G2170-90037 OpenLABOption

Agilent ChemStation
OpenLAB Option
Concepts Guide
ChemStation OpenLAB Option Concepts Guide
Agilent Technologies
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In This Guide ...
In This Guide ...
This guide contains installation and reference information for ChemStation

OpenLAB Option G2189BA, the ECM interface between Agilent ChemStation
and an Agilent Enterprise Content Manager (ECM) client/server system.
1 Introduction
This chapter introduces ECM, the implementation of OpenLAB Option in
ChemStation, and the requirements of 21 CFR Part 11.
2 Installation
This chapter describes the installation and configuration of ChemStation
OpenLAB Option.
3 Basic Concepts of ChemStation OpenLAB Option

This chapter describes how to log in to ECM in ChemStation, and explains the
ECM-related user interface items and toolbars, as well as the main preference
settings.
4 Working With ChemStation OpenLAB Option

This chapter describes the basic workflows with ChemStation OpenLAB
Option. There are four data-related workflows and two workflows for methods
and sequence templates.
5 Administration Regarding 21 CFR Part 11 Compliance

This chapter explains the purpose of 21 CFR Part 11 and its implementation in
ChemStation with ChemStation OpenLAB Option.
6 Custom Fields
This chapter explains the purpose and usage of custom fields in ChemStation.
ChemStation OpenLAB Option Concepts Guide 3

In This Guide ...
7 Treatment of ChemStation Legacy Data and Data Migrated from ChemStore

This chapter provides information on migrating legacy ChemStation sequence
data to sequence container format, in order to be able to upload these data
sets to ECM.
8 Interface to OpenLab Intelligence Reporter

This chapter provides information on the integration of OpenLAB Intelligence
Reporter in Agilent ChemStation.
9 Attribute Extraction Services for ChemStation Data

This chapter provides an overview of the available ECM Attribute Extraction
Services (AES) for ChemStation data. The AES extract metadata information
from the ChemStation data files. These metadata make the ChemStation data
searchable. For detailed information, refer to the ECM documentation.
10 Using Print Services in ChemStation

This chapter gives a brief overview of how to install and configure the Print
Services. This enables you to automatically upload ChemStation reports to
ECM in a PDF format.
11 Troubleshooting
The chapter gives some elementary troubleshooting hints.
12 Appendix
4 ChemStation OpenLAB Option Concepts Guide

Contents
Contents
1 Introduction 9
What is ECM? 10
Add-On Solution for ChemStation: OpenLAB Option 11
Data Storage in ECM 16
21 CFR Part 11 Compliance 17
2 Installation 19
Prerequisites 20
Compatibility 21
Support for Windows 7 with OpenLAB Option 22
Installation and Configuration Tasks on ECM Server 23
Installation Tasks on the ChemStation Computer 28
Uninstallation 37
3 Basic Concepts of ChemStation OpenLAB Option 39

User Permissions 40
OpenLAB Option User Interface in ChemStation 43
ECM Preferences 47
Remote Data Path as Sequence Parameters 57
Compressed ChemStation File Formats 59
4 Working With ChemStation OpenLAB Option 61

Transferring Data to or from ECM 62
Data-related workflows 63
Workflows for Methods and Sequence Templates 74
5 Administration Regarding 21 CFR Part 11 Compliance 83

Introduction to 21 CFR Part 11 84
Overview of Configuration Steps Required for Part 11 87
Audit Trails and Logbooks 88
Administration in ECM 93
Administration of ChemStation Settings 97
Electronic Signature 100

Contents
6 Custom Fields 103

About Custom Fields 104
Setting Up Custom Fields 105
Specifying Custom Fields Values 108
Reporting of Custom Fields 110
Reprocessing with Custom Fields 112
7 Treatment of ChemStation Legacy Data and Data Migrated from

ChemStore 113
Introduction 114
Result set Migration 115
Conversion of Data Migrated from ChemStore 117
8 Interface to OpenLab Intelligence Reporter 119

Introduction 120
Interface Components Concerning OpenLAB IR 128
9 Attribute Extraction Services for ChemStation Data 131

Attribute Extraction Services for ChemStation Data 132
ACAML Filter 135
ChemStation XML Attribute Extraction Service 136
ChemStation Filter 137
10 Using Print Services in ChemStation 139

ECM Print Services 140
Setting Up ECM Print Services 141
Configuring ECM Print Services for use with Amyuni PDF Converter 142
Configuring ECM Print Services - Adobe Distiller 144
Working with ECM Print Services in ChemStation 146
11 Troubleshooting 147
General Problems 148
Alerts and Error Messages at ChemStation Startup 149
Error Messages in the Spooler Queue Manager 150

Contents
12 Appendix 153
ChemStation Privileges in ECM 154
ChemStation Roles in ECM 157
ECM related privileges concerning the ChemStation configuration 161

Contents

1
Introduction
What is ECM? 10
Add-On Solution for ChemStation: OpenLAB Option 11
Overview of data-related workflows 12
Overview of workflows for methods/sequence templates 14
Data Storage in ECM 16
21 CFR Part 11 Compliance 17
This chapter introduces ECM, the implementation of OpenLAB Option in

ChemStation, and the requirements of 21 CFR Part 11.
Agilent Technologies 9
1 Introduction
What is ECM?
What is ECM?
The Agilent Enterprise Content Manager (ECM) is a web-based electronic

library that allows you to safely archive and catalog any electronic file. ECM
allows you to store and index analytical raw data, reports, and all other types
of documents. The stored files can be shared with other users.
You can store any electronic file type, such as Microsoft Office documents,
Adobe PDF documents, images, and molecular drawings, as well as raw data
and reports generated by ChemStation.
ECM allows you to easily collect, organize, search, and review all of your data.
It automatically extracts searchable metadata from files, and provides
powerful search capabilities. In addition, ECM provides embedded viewers for
many file types.
The ECM interface is opened via Microsoft Internet Explorer, also referred to
as the ECM Web Client.

Introduction 1
Add-On Solution for ChemStation: OpenLAB Option
Starting with revision B.02.01 SR1, Agilent ChemStation provides an interface

to the Agilent Enterprise Content Manager (ECM), which enables you to store
analytical data and reports in a secure location. From ChemStation, you can
log in to ECM and store methods, sequence templates, data files, and reports
in ECM. Data storage can be either automatic (that is, at the end of a single
run or sequence) or manual. ChemStation data stored in ECM can later be
downloaded to ChemStation for review or reprocessing at any time.
Furthermore, ChemStation OpenLAB Option offers features that enable users
to comply with 21 CFR Part 11 and similar regulations for electronic records
and electronic signatures:
• Mandatory login/connection to ECM
• Configurable session locking
• Configurable ChemStation user roles and privileges
• Full data traceability through audit trails for methods and results
• Full data versioning
ChemStation OpenLAB Option requires the following components:
• ECM Server
• ChemStation OpenLAB Option installed on the ECM Server
• ECM Web Client installed on the ChemStation computer
• ChemStation with ChemStation OpenLAB Option installed on the
ChemStation computer
• Connection between the ChemStation computer and the ECM Server
The main workflows for the transfer of raw data and methods/sequence
templates are listed below. These workflows indicate the system activities in
relation to the work processes.

1 Introduction
Overview of data-related workflows
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Workflow 1: Raw data acquisition and automatic transfer to ECM

1 Analytical raw data is acquired using ChemStation.
2 The raw data is automatically uploaded to ECM using the configured path
definitions immediately after the single run/sequence is finished.
3 A new ECM data set is created in the defined ECM location.

Introduction 1
Workflow 2: Offline revision during acquisition

1 Analytical raw data is acquired using ChemStation.
2 While the acquisition is still running, part of the data is changed using an
offline ChemStation.
3 The raw data is automatically uploaded to ECM using the configured path
definitions immediately after the single run/sequence is finished.
A new ECM data set is created in the defined ECM location.
4 After work in the offline ChemStation is finished, the changed data is also
automatically uploaded to ECM.
Another new version of the ECM data set is created.
Workflow 3: Reprocessing data and automatic upload to ECM

1 Existing analytical data is loaded from ECM into ChemStation.
2 The data is reprocessed in ChemStation.
3 The data is automatically uploaded to ECM. The location in ECM is defined
by the original path definitions of the downloaded ECM data.
4 A new version of the data is created in ECM.
Workflow 4: Import after reprocessing

1 Existing analytical data is opened locally.
2 The data is reprocessed in ChemStation.
3 After reprocessing, the data is automatically uploaded to ECM. The location
in ECM is defined by the current preferences in ChemStation.
4 A new version of the data is created in ECM.
For more details, and for additional workflows, refer to “Data-related
workflows” on page 63

1 Introduction
Overview of workflows for methods/sequence templates
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Workflow 1: Uploading a new method

1 A new method or sequence template is created.
2 The method or sequence template is uploaded to ECM using the path
selected by the user.
3 The version 1 of the method or sequence template is automatically created
in ECM.

Introduction 1
Workflow 2: Saving a changed method

1 An existing method or sequence template is loaded from ECM.
2 The changed method or sequence template is saved to ECM.
3 A new version of the method or sequence template is automatically created
in ECM.
For more details, and for additional workflows, refer to “Workflows for
Methods and Sequence Templates” on page 74

1 Introduction
Data Storage in ECM
Data Storage in ECM
ECM provides a four-level data storage model with the structure of Location,
Cabinet, Drawer, Folder. The Location, Cabinet, Drawer and Folder names
comprise the path name (called either LCDF path or Remote Data Path) of the
storage location. Data is stored at Folder level only.
The ECM program’s content structure is similar to rooms filled with file
cabinets. Each cabinet has multiple drawers, which then contain hanging
folders. Finally, paper files are stored in the folders. The LCDF structure can
be created using the ECM Web Client. In addition, it is possible to create
additional Locations, Cabinets, Drawers, and Folders using the ChemStation
Remote Data Path. In ChemStation, it is also possible to set predefined tokens
for the Drawers and Folders.
In the ECM tree view, locations are denoted by a house icon. Inside each
Location, Cabinets are denoted by the file cabinet icon. Inside each Cabinet,
Drawers are denoted by the drawer icon. Finally, inside each Drawer, Folders
are denoted by the folder icon. The entire content structure appears in the
Content book.
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Figure 1 LCDF structure in ECM
Uploaded objects can be stored in the lowest (i.e. Folder) level only. It is not
possible to upload data to other levels of the hierarchy.

Introduction 1
21 CFR Part 11 Compliance
Effective August 20, 1997, the U.S. Food and Drug Administration (FDA)
released and published a new rule to enable pharmaceutical companies to
approve their results with electronic signatures and to transfer paper-trail
documentation into electronic records. This rule is known as 21 Code of
Federal Regulations Part 11 (referred to as 21 CFR Part 11) and applies to all
industry segments regulated by the FDA.
21 CFR Part 11 includes the US Federal guidelines for storing and protecting
electronic records and applying electronic signatures. The intent of these
guidelines is to ensure that electronic records subject to these guidelines are
reliable, authentic, and maintained with high integrity.
ChemStation OpenLAB Option with ChemStation B.04.xx provides the
necessary controls for managing system access, audit trail functions,
versioning of ChemStation data, and electronic signature functions. Agilent
OpenLAB ECM ensures secure record keeping and data archival. Agilent
OpenLAB ECM is proven and has been deployed at many leading life sciences
companies to satisfy compliance mandates for 21 CFR Part 11.

1 Introduction

2
Installation
Prerequisites 20
Compatibility 21
Support for Windows 7 with OpenLAB Option 22
Installation and Configuration Tasks on ECM Server 23
Updating the ECM Database 23
Updating roles in existing ECM Accounts 25
Configuring users, roles and privileges 26
Installation Tasks on the ChemStation Computer 28
Preparing the ECM Web Client 29
Installing a new ChemStation with ChemStation OpenLAB Option 29
Adding ChemStation OpenLAB Option to an existing ChemStation 33
Enabling users to start the ChemStation Administration Tool 34
Uninstallation 37
To uninstall Agilent ChemStation und Windows XP 37
To uninstall other ChemStation components 37
This chapter describes the installation and configuration of ChemStation

OpenLAB Option.
2 Installation
Prerequisites
Prerequisites
Before you install Agilent ChemStation OpenLAB Option, make sure that the
following prerequisites are met:
• The ECM Server software must be installed and configured as described in
the Enterprise Content Manager Installation Guide. All server-related
prerequisites, as well as the installation and configuration details, are
described in the guide.
The ECM versions supported with ChemStation are:
• OpenLAB ECM Workgroup 3.3.1 - MS SQL Server 2005, with ECM 3.3.1
Hotfixes 1-5,
• OpenLAB ECM Enterprise with ECM 3.3.1 Hotfixes 31, 45, 47-54, 56-57,
59, and 70,
• OpenLAB ECM Workgroup 3.3.2 SP1 - MS SQL Server 2005,
• OpenLAB ECM Enterprise 3.3.2 SP1 - MS SQL Server 2005, or
• OpenLAB ECM Enterprise 3.3.2 SP1 - Oracle 10.2.0.1 or Oracle database
server 10.2.0.4 with Oracle client 10.2.0.1
• Ensure that the minimum PC and operating requirements are met for
ChemStation. Details can be found in the Installing your ChemStation
manual for your respective instrument.
• Setting up the connection from ChemStation to the ECM Server requires
the address of the ECM Server.

Installation 2
Compatibility
Compatibility
ChemStation Add-Ons
ChemStation OpenLAB Option is not supported in combination with the
following ChemStation Add-Ons and features:
• ChemStore / Security Pack
• Purify
• Easy Access
• ChemStation Unique Folder Creation OFF (item is not accessible)

2 Installation
Support for Windows 7 with OpenLAB Option
Support for Windows 7 with OpenLAB Option
Please note that the installation instructions in the following sections describe
installation of OpenLAB Option on client computers running on Winodws XP
or Windows Vista.
For ChemStation computers running on Windows 7 a different ECM API is
required and the ECM server requires an update to support the new API. For
details about Windows 7 support with ChemStation OpenLAB Option, please
refer to the ReadMe.txt file on the ChemStation B.04.03 DVD. The ReadMe.txt
is also available in the ChemStation program group after installation of the
ChemStation.

Installation 2
Installation and Configuration Tasks on ECM Server
You must execute the database script for ChemStation privileges on the ECM
Server to implement ChemStation related users, roles and privileges within
OpenLAB ECM. In addition, after installing the program, you must take care of
several ECM settings.
Updating the ECM Database

A database script is provided on the ChemStation DVD that creates specific
ChemStation privileges and ChemStation roles in ECM. The procedure
depends on the ECM Database type (Oracle or SQLServer).
Prerequisites
You need the login data of the following users:
• A Windows user who can connect to the ECM Database.
• An ECM Database user who is authorized to access the ECM schema and to
update the tables in this schema.
To update an Oracle ECM Database

1 Log on to a Windows computer that has SQLPlus installed.
2 Insert the ChemStation DVD in your DVD drive. Navigate to the folder
ECM-DatabaseScript\Oracle.
3 If you have the password for the database user SYS, execute InstallOracle.cmd.
Otherwise, execute InstallOracleNonSYS.cmd.
A command window opens.
4 You are prompted to enter several parameters. Type in the required data
and press Enter to confirm each entry:
• Database name (host string): The host string for your ECM Database.
• User name: A user name is only requested if you executed
InstallOracleNonSYS.cmd.

2 Installation
• Path and filename of the log file: An installation log file is created in the
given location.
• Password for database user: The password is not shown while typing.
• Schema/user name for ECM
• Directories where the data files, index files, and map files of the new
database schema should be stored.
5 Review the data.
• If something is wrong: press Ctrl+C to abort the installation.
6 If everything is OK: Press Enter.
The installation begins. When the installation is finished, the text Installation
finished is shown in the command window.
7 Press any key to close the command window.
8 Check the installation log file. It should only include messages about
changing the database, no warnings or errors.
To update an SQLServer ECM Database

1 Log on to a client that has SQLCmd installed.
2 Insert the ChemStation DVD in your CD-ROM drive. Navigate to the folder
EMC-DatabaseScript\SQLServer.
3 If you have the password for the database user SA, execute InstallSQL.cmd.
Otherwise, execute InstallSQLNonSA.cmd.
A command window opens.
4 You are prompted to enter several parameters. Type in the required data
and press Enter to confirm each entry:
• ECM Database Server: Server name of the ECM Database Server.
• ECM Database Name
• Database User Name: Normally:
CYBERLABLOGIN
• Directory and Name for log file: An installation log file is created in the given
location.
5 Review the data.
• If something is wrong: press Ctrl+C to abort the installation.

Installation 2
6 If everything is OK: Enter the password for the database user you provided
before.
The installation begins. When the installation is finished, the text Installation
finished is shown in the command window.
7 Press any key to close the command window.
8 Check the installation log file. It should only include messages about
changing the database, no warnings or errors.
Updating roles in existing ECM Accounts

When updating the ECM Database, certain specific ChemStation roles and
privileges have been created. If you create a new ECM Account, these roles
their privileges are automatically available in that new account. However, if
you want to use ChemStation OpenLAB Option with an existing ECM Account,
you must first update the roles in that specific account. The new ChemStation
roles and their privileges will be available only after updating the roles for the
existing account.
To make the new roles and privileges available in an ECM Account
All system roles will be reset to default when performing Reset Role. If you made manual
NOTE changes to a system role, these changes will be lost!
All other roles that were created manually will be deleted!
1 Open a browser window and connect to the ECM Web Server.

2 Log in to the ECM Account in which you want to update the roles.
3 Select the Administration tab.
4 Click Account Administration.
5 Double-click Users / Groups / Roles.
The Account Administration dialog opens.
6 Select the Roles tab.
7 Click Reset Roles.

2 Installation
The default ChemStation roles and the according ChemStation privileges

(see “ChemStation Roles in ECM” on page 157) are now available in the
current account and can be assigned to the users.
The default ChemStation roles do not contain any ECM privileges! A ChemStation user who
NOTE wants to access ECM must additionally be assigned the required ECM roles (see
“Assigning roles” on page 27 and “ECM related privileges concerning the ChemStation
configuration” on page 161).
Configuring users, roles and privileges

Concept of users, roles, and privileges
In ECM, you can either create specific ECM users or operate with the Windows
users. Each user can be member of a specific group. The available groups
depend on the ECM configuration.
You must assign a specific ECM role to each group. You can also assign roles to
single users, however, for the sake of clarity, it is strongly recommended to
assign roles only on the group level.
The roles are equipped with numerous specific privileges, which define what
the users are allowed to view or do in ECM and in ChemStation.
Once you created a new ECM user, group, or role, you can not delete it again. You can only
NOTE deactivate the unused item.
Default roles and privileges

There are a number of default roles and privileges in ECM that are created
during the installation of ECM and ChemStation OpenLAB Option. The
following tables show an overview of these roles and privileges.
Name Description
• Starting with “:CS” Default ChemStation role.

Can be restored by the Reset Roles function.
• Starting with “:” Default ECM role. Can be restored by the Reset Roles function.

Installation 2
Name Description
• Starting with “CS:” Privilege related to ChemStation

For details on the ChemStation privileges, see “Appendix” on
page 153.
• Starting with “Content:” Privilege related to ECM
• Starting with “System:” Privilege related to ECM
In addition, you can create your own roles in ECM, or grant further privileges
to the default roles. For detailed information, refer to the ECM
Administrator’s Guide.
Assigning roles
Users do not need any specific role in order to log in to ECM. However, in
order for users to see a particular Location, Cabinet, Drawer, or Folder in the
user interface, they must have the :Reader role as a minimum requirement. As
a result, domain users with no global roles might not be able to view anything
in the content unless they were granted the appropriate privileges.
You should grant the users of the ChemStation OpenLAB Option the
:Contributor role. This can be done at the global level for the entire ECM
Account, or individually for specific folders (see “Roles and folders” on
page 96). The :Contributor role allows the ChemStation OpenLAB Option user to
view and add content to ECM. The :Contributor role should be enhanced with
the Content: Add Folder privilege. This allows ChemStation ECM users to add
folders to the LCDF hierarchy.
If the role does not include the Add Folder privilege, the users cannot add a new Remote
NOTE Data Path (LCDF) in ChemStation.
In addition to the ECM roles, user of ChemStation OpenLAB Option must be

assigned at least one of the ChemStation roles or another, customized role
with according ChemStation privileges. You find a complete list of all
ChemStation roles and all relevant privileges in the Appendix.
If a ChemStation user has no ChemStation privileges in ECM, this user is not able to work
NOTE with ChemStation OpenLAB Option!

2 Installation
Installation Tasks on the ChemStation Computer
ChemStation OpenLAB Option (G2189BA) is a separate installation package

delivered on the ChemStation DVD. It can be initially installed with the
ChemStation software, or added to an existing ChemStation. After
installation, ChemStation OpenLAB Option is available for all ChemStation
instances installed on the particular client PC.

Installation 2
Preparing the ECM Web Client

Preparations You need to make sure there is an up-to-date version of the ECM Web Client installed on the
ChemStation computer.
If you use Windows Vista: Make sure the User Account Control feature is disabled before
NOTE you connect to ECM!
To prepare the ECM Web Client

1 On the ChemStation computer: Open a browser window and connect to the
ECM Web Server.
2 Log in to ECM.
All relevant hotfixes are automatically installed. You may be asked to
restart the ChemStation computer during the installation.
Installing a new ChemStation with ChemStation OpenLAB Option

Before installing the software, verify that all prerequisites are met (see
“Prerequisites” on page 20).
The installation is divided in the following steps:
• Installing the ECM API
• Installing ChemStation
• Adding instruments
• Providing license keys
• Configuring instruments
To install the ECM API

1 Insert the ChemStation DVD into the DVD drive.
2 In Windows Explorer, navigate to the folder [diskdrive]:\ECMAPI and
double-click the file ECMAPIDeploy.mci.
The Agilent OpenLAB ECM API Installation wizard Opens.
3 Click Next.

2 Installation
4 Enter User Name and Organization. Select the option to install the API for
“Anyone who uses this computer (all users)”. Click Next.
5 Select a destination folder where you want to install the ECM API (the
default folder is C:\Program Files\Agilent Technologies\ECM API\1.0.24.1). Click
Next.
6 Click Install.
7 After the installation has completed, click Finish.
To install ChemStation
1 Insert the ChemStation DVD into the DVD drive.
2 From the Start menu in the Task Bar, select Start > Run.
3 At the command line, type
[diskdrive]:\Setup For example: D:\Setup
The setup software checks if the following software components are
available:
• Microsoft .NET Framework 3.5 SP1
• PDF-XChange 4.0
4 If there are missing components, additional dialogs open to install these
components. Click Install to install the missing components. For the
Microsoft .NET Framework also read and agree to the License Agreement.
After the missing components have been installed, the Agilent ChemStation
Setup Wizard opens.
5 Click Next.
6 Select the check box to confirm the license agreement. Click Next.
7 Select a destination folder where you want to install the new ChemStation
(the default folder is C:\Chem32). Click Next.
8 Click Install.
ChemStation is now being installed. This can take several minutes.
9 Click Finish.
The Setup Wizard - Instruments dialog opens. Proceed now with adding the
instruments.

Installation 2
To add instruments
1 In the Setup Wizard - Instruments dialog, click the Add buttons to add the
required instruments.
Figure 2 Setup Wizard - Instruments
2 Under General Addon products, select the ChemStation OpenLAB Option check
box.
3 Click Next.
The Setup Wizard - Licenses dialog opens.
4 Proceed now with providing the license keys.
To provide license keys

1 In the Setup Wizard - Licenses dialog, enter a valid license key for
ChemStation OpenLAB Option in the input field at the bottom.
The applicable license product and license numbers are printed on your Software
NOTE Certificate and Registration Packet.

2 Installation
Note that any Windows user with administrative privileges can remove the G2189BA
NOTE OpenLAB Option license and thus disable OpenLAB Option functionality from the
ChemStation. It is therefore recommended that in an regulated environment ChemStation
users work as Windows Users or Powerusers.
2 Click Add to add the license key to the list.

3 Provide valid license keys accordingly for all of the instruments shown in
the list.
The software automatically recognizes which license is valid for which
module.
4 Click Next.
The ChemStation Administration Tool dialog opens.
Figure 3 ChemStation Administration Tool
5 Select or clear the Mandatory Login check box, depending on whether the
ECM login should be mandatory or optional in ChemStation (the settings
will be used for all ChemStation instances that are installed on this
computer). For more details on the login functions see “User
Permissions” on page 40.

Installation 2
You do not need to configure the other options in this dialog during the installation. You can
NOTE configure these items anytime in ChemStation (see “ECM Preferences” on page 47 and
“Audit Trails and Logbooks” on page 88) or by using the ChemStation Administration Tool
directly (see “ChemStation Administration Tool” on page 97).
6 Click OK.
7 Click Finish.
The Configuration Editor opens.
8 Proceed now with configuring the instruments.
To configure instruments
You can configure the instruments in the Configuration Editor. For details see
the manual Installing your ChemStation.
After the successful installation, ChemStation contains the new ECM menu
and a number of other ECM interface elements (see “Overview of new
interface elements” on page 43.
Adding ChemStation OpenLAB Option to an existing ChemStation

To add ChemStation OpenLAB Option subsequently
1 From the Start menu in the Task Bar, select Start > All Programs > Agilent
ChemStation > Add instrument.
The Setup Wizard - Instruments dialog opens (see Figure 2 on page 31).
2 Under General Addon products, select the ChemStation OpenLAB Option check
box.
3 Click Next.
The Setup Wizard - Licenses dialog opens.
4 Enter a valid license key for ChemStation OpenLAB Option in the input
field at the bottom.
5 Click Add to add the license key to the list.
6 Click Next.
The ChemStation Administration Tool dialog opens (see Figure 3 on page 32).

2 Installation
7 Select or clear the check box Mandatory Login, depending on whether the
ECM login should be mandatory or optional in all ChemStation instances
on this computer.
8 Click OK.
9 Click Finish.
The Configuration Editor opens. As you have already configured the
instruments, and have now added the OpenLAB Option, you can exit the
Configuration Editor without any further actions.
10 Prepare the ECM Web Client and install the ECM API as described in
“Preparing the ECM Web Client” on page 29.
Enabling users to start the ChemStation Administration Tool

The ChemStation Administration Tool is automatically installed as a part of
ChemStation OpenLAB Option during the procedure described above.
The ChemStation Administration Tool offers you to change the transfer
settings (see “Automatic Data Transfer Settings” on page 50) for all
ChemStation instances on a computer in a single step. In addition, there are a
number of functions which are helpful if the connection from the ChemStation
client to the ECM Server is lost. As one of these functions is to switch off the
mandatory ECM login, access to the ChemStation Administration Tool must be
strictly limited.
During the Installation of ChemStation OpenLAB Option, the local user group
CSAdministrators is automatically created. Only members of this group are
allowed to run the ChemStation Administration Tool. The user who installs
ChemStation, is automatically added to the CSAdministrators group.
Additionally, the Windows group Administrators and the user who installs
ChemStation are granted Full Control privileges on the Administration Tool
program executable (Agilent.ChemStation.ECM.ECMAdmin.exe) itself, thus
they are able to run the tool.
See “Administration of ChemStation Settings” on page 97 for more details on the

NOTE ChemStation Administration Tool.

Installation 2
To add a Windows user to the CSAdministrators group:

1 From the Start menu in the Task Bar, select Start > Settings > Control Panel >
Administrative Tools > Computer Management.
The Computer Management window opens.
Figure 4 Computer Management window
2 Right-click the group CSAdministrator and select Add to Group... from the
context menu.
The Properties dialog shows the users who are currently member of the
group.

2 Installation
3 Use the Add button to add the required users.

After confirming with OK, the Properties dialog also contains the newly
added users.

Installation 2
Uninstallation
Uninstallation
To uninstall Agilent ChemStation und Windows XP

To uninstall Agilent ChemStation und Windows XP
1 From the Start menu in the Task Bar, select Start > Settings > Control Panel >
Add or Remove Programs.
2 Select the Agilent ChemStation program and click Remove.
3 When asked for confirmation, click Yes.
To uninstall Agilent ChemStation under Windows Vista

1 From the Start menu in the Task Bar, select Start > Control Panel >
Programs > Programs and Features.
2 Select the Agilent ChemStation program and click Uninstall.
3 When asked for confirmation, click Yes.
The program is uninstalled. All files of the ChemStation folder (by default:
C:\chem32) are removed. Only files that have been modified by the user (for
example, methods, sequence templates, or data files) are not deleted.
To uninstall other ChemStation components

During the installation of ChemStation, a few additional components were
installed. You can remove these components using the Add or Remove Programs
function, with which you can also remove ChemStation.
The following components may have been installed together with
ChemStation:
• PDF-XChange 4.0
• Microsoft .NET Framework 3.5 SP1

2 Installation
Uninstallation

3
Basic Concepts of ChemStation
OpenLAB Option
User Permissions 40
Log In/Log Out 40
ChemStation Operator and ECM User 41
Session lock 41
OpenLAB Option User Interface in ChemStation 43
Overview of new interface elements 43
The ECM menu 44
ECM Preferences 47
Remote Data Path 48
Automatic Data Transfer Settings 50
Transfer Management Settings 52
Spooler Queue Manager 53
Remote Data Path as Sequence Parameters 57
Compressed ChemStation File Formats 59
This chapter describes how to log in to ECM in ChemStation, and explains the
ECM-related user interface items and toolbars, as well as the main preference
settings.
User Permissions
User Permissions
Log In/Log Out

To prevent unauthorized access to ECM or unauthorized use of ChemStation
OpenLAB Option, ECM requires authentication with a user name and
password. In addition, each user needs user privileges defining the accessible
content.
The user administration is set up and managed on the ECM Server. For more
details about login and user setup refer to the ECM User/Administrator's
Guide.
Optional or mandatory
Depending on the configuration during the installation of ChemStation, the
ECM login can be optional or mandatory. If it is mandatory, you must log in to
ECM during the ChemStation startup. If it is optional, you can initially skip
the login and then log in to ECM later.
If you are already logged in to ECM server in the online instrument session
and start the offline session via the item Reprocessing Copy from the View
menu, the user will be automatically connected to ECM with the same login
information (silent login).
If you are not connected to ECM, all of the ECM functions are grayed out.
You can log in to ECM from the following ChemStation views:
• Method and Run Control
• Data Analysis
Once you have logged in to ECM, it is possible to upload data to ECM and
simultaneously work on the local ChemStation file system.
The login is dependent on the instrument session; only one user can be logged
in to ECM at any one time. If another user wants to log in, you must first log
out.

Basic Concepts of ChemStation OpenLAB Option 3
User Permissions
User credentials
The Login dialog requires you to enter a set of valid authorization details in
order to log in to ECM. The login information is ECM Server-specific and will
be provided by the ECM administrator.
You need to enter the following login details:
• Server URL: the URL of the ECM Server
• Account: you can store content to the locations assigned in the specific
account; one ECM Server may have several accounts.
• Username: the user name defined in the ECM Account, or your NT domain
user name (depending on the user configuration in ECM)
• Password: the password provided by your administrator, which can be
changed on request (for ECM ‘built-in’ users), or the password of your NT
domain account, if you are logging in using your NT domain user name.
• Log on to: the domain administrating the ECM users
ChemStation Operator and ECM User

If you log in to ECM and have been authorized by the ECM system, the
ChemStation operator name in the sample info (when running single samples)
or the sequence parameters (when running a sequence) is overwritten by your
ECM user name.
As long a user is logged on to ECM, the operator name is given by the ECM
logon and cannot be overwritten. As soon as you log out of ECM, the
ChemStation operator name defined by the ECM is removed, and is replaced
by the entry “disconnected”. While acquiring data to ECM, it is not possible
either to log in or to log out of ECM. This prevents the operator name from
being changed during data acquisition.
Session lock
If you leave the ChemStation computer for a certain period of time, you can
lock ChemStation so that no other user can access the program. This is a
safety feature to ensure that there is no unauthorized access to ChemStation.

User Permissions
When you activate the session lock, you or another user must first provide a
valid ECM login before continuing to work with ChemStation.
There are the following options to activate the session lock:
• Privately (ECM > Lock Session > privately): Only the user who activated the
session lock, or a user with the CS: Break Session Lock privilege, can log in.
• Non privately (ECM > Lock Session > non privately): Any valid ECM user can
log in. This is useful, for example, if there is a shift change, and the leaving
personnel secures ChemStation until the personnel of the new shift starts
work.
• Toolbar Lock Button: The toolbar lock button can be configured to lock the
ChemStation session privately or non privately (see “Login options” on
page 98).
• Time based: Depending on the ECM Account configuration, ChemStation is
automatically locked after a given period of time without any user
interaction (see Inactivity Timeout under “Administration in ECM” on
page 93). If there is no activity in an ECM Web Client, the ECM Web Client is
also locked after the given period of time. ChemStation and ECM Web Client
are locked independently from each other.
The time based session lock can be configured to lock the ChemStation
session either privately or non privately (see “Login options” on page 98).

OpenLAB Option User Interface in ChemStation
Overview of new interface elements

With the installation of ChemStation OpenLAB Option, the following new
menus, menu items, and interface elements are available:
Menu New elements Description
Method New command See “Method Audit Trail” on

• Enable Audit page 88
Trail
Sequence > Sequence Parameters, Sequence Parameters tab New fields on the See “Remote Data Path as
Sequence Sequence Parameters” on page 57
Parameters tab:
• Remote Data
Path
Sequence > Sequence Parameters, Sequence Output tab New fields on the See “Template selection in
Sequence Output Sequence Output” on page 128
tab:
• OpenLAB
Intelligence
Reporter
Template
Report New command See “Report History” on page 90

• Report History
View > Preferences New tabs in the See “ECM Preferences” on page 47
Preferences and “Audit Trails and
dialog: Logbooks” on page 88
• Transfer
Settings
• Audit Trail
ECM Completely new See “The ECM menu” on page 44

menu

Menu New elements Description

Toolbar (depending on the current view) • Shortcuts to • LCDF info in the Data Analysis
several view: shows the LCDF path of a
commands of file that has been stored to
the ECM menu ECM.
• LCDF info • LCDF info in the Method and
Run Control view: drop down
list showing the last ten LCDF
paths as defined in the
Preferences if the automatic
upload After Acquisition is
selected.
ECM related details in the System Diagram in Method and Run Completely new The following details are available:
Control view (classic UI only). details view • LCDF
• Operator
• Automatic transfer after
acquisition
• Automatic transfer after
reprocessing
• Automatic transfer after any
data modification
• Automatic import after
reprocessing
• Calculate peak performance
The ECM menu

The ECM menu and its commands depend on the view that is currently active.
See the following table for details.
There is no ECM menu in the Report Layout, Verification (OQ/PV), or Diagnosis view.
NOTE

Command Description Available in ChemStation views
User-related commands: See “User Permissions” on page 40 and “Session • Method and Run Control
lock” on page 41. • Data Analysis
Log In ...
Log out
Change User ...
Lock Session
Update-commands: Update all methods/sequence templates that are • Method and Run Control
Update Methods ... stored in the local file system with the current
Update Sequences Templates ... version from ECM (if existing in ECM). Local
changes are overwritten.
Cleanup Data The Cleanup Data command deletes all data or • Data Analysis
sequence containers from the local file system
that exist in ECM as well. Make sure you uploaded
the latest version to ECM before you confirm this
command. See “Cleanup Data on Shutdown” on
page 52.
Manage Queue With the Manage Queue command you can • Method and Run Control
continue any interrupted data upload to ECM. See • Data Analysis
“Manage Queue on Connect” on page 52.
See “ECM Preferences” on page 47 for more • Method and Run Control
Preferences details on the Preferences dialog. • Data Analysis
Method-related commands: See “Workflows for Methods and Sequence • Method and Run Control
Templates” on page 74 • Data Analysis
Load Method ...
Save Method
Data-related commands: See “Data-related workflows” on page 63 • Data Analysis
Load Data ...

Save Data
Save Data As ...

Command Description Available in ChemStation views
Commands related to the sequence See “Workflows for Methods and Sequence • Method and Run Control
template: Templates” on page 74
Load Sequence Template ...
Save Sequence Template
Commands related to OpenLAB See “Interface Components Concerning OpenLAB • Data Analysis
Intelligence Reporter: IR” on page 128
Start OpenLAB IR
Create OpenLAB IR Report

ECM Preferences
ECM Preferences
The Preferences dialog contains two tabs that are relevant to ChemStation
OpenLAB Option: the Transfer Settings tab and the Audit Trail tab.
Several settings in the Transfer Settings tab and the Audit Trail tab may have been
NOTE specified for all ChemStation instances on the computer via the ChemStation
Administration Tool (see “ChemStation Administration Tool” on page 97). In this case, you
cannot change the settings in the Preferences dialog.
On the Transfer Settings tab, you must specify the following preferences in order
to automatically store ChemStation data to ECM:
• Remote Data Path
• Automatic Data Transfer Settings
• Transfer Management Settings
Figure 5 Transfer Settings tab in the Preferences dialog
All of these items can be specified independently for each instrument. Offline
and online sessions are automatically synchronized.

ECM Preferences
On the Audit Trail tab, you can enable the Method Audit Trail and Results Audit
Trail. For details on audit trails see “Audit Trails and Logbooks” on page 88.
Figure 6 Audit Trail tab in the Preferences dialog
You can change these settings for all ChemStation instances on the client PC in one single
NOTE step by using the ChemStation Administration Tool (see “ChemStation Administration
Tool” on page 97).
Remote Data Path

In ChemStation OpenLAB Option, the Remote Data Path needs to be specified in
order to save the data to the correct location in ECM.
In the Preferences dialog, the Transfer Settings tab (see Figure 6 on page 48)
allows you to define the Remote Data Path. The Remote Data Path reflects the
LCDF structure in ECM.
Server/Account
In the text fields Server and Account, you can specify the ECM Server and ECM
Account that you want to use to store the ChemStation data.

ECM Preferences
At your first login from ChemStation to ECM, you must specify the server and
account information. You can either enter the information manually, or you
can click Get Server to fill the fields with the Server and Account where you are
currently logged in. ChemStation then keeps the Server and Account
information for future sessions.
If you log in to a different ECM Server later, you have to update the Server and
Account information. You can click Get Server again to fill the fields with the
current ECM Server name and the current ECM Account.
Path
To specify the Remote Data Path, you need to select a Location and Cabinet
available in the ECM Browser. Click Select Path to select the required path in
an ECM Explorer dialog.
If no Remote Data Path is specified, a warning message will be shown at ChemStation

NOTE startup.
For the Drawer and Folder, you can either keep the selected items, or you can
select predefined tokens for an automatic path creation. When you use the
predefined tokens in the Remote Data Path, the system automatically creates
the items if they do not already exist in ECM.
If you use tokens, make sure you have the required ECM privileges to create folders!
NOTE Alternatively, another user who has the required privileges can create the necessary folders
in advance.
Alternatively, the Remote Data Path can be specified as Sequence Parameter (see
“Remote Data Path as Sequence Parameters” on page 57). Uploaded objects
can be stored only at the Folder level.

ECM Preferences
Table 1 Remote Data Path items
ECM Data Path Item Convention
Location Fixed location

to be selected in ECM
Cabinet Fixed cabinet

to be selected in ECM
Drawer Drawer available in ECM

Tokens: Instrument Name, Instrument Number, Operator
Folder Folder available in ECM

Tokens: Instrument Name, Instrument Number, Operator
Automatic Data Transfer Settings

In the Preferences dialog (View > Preferences), the ECM tab allows you to specify
the automatic settings for the transfer of raw data. The transfer settings, as
well as the Remote Data Path, are used to automatically upload data to ECM.
If you are not logged in to ECM in ChemStation, the data cannot be automatically uploaded
NOTE to ECM as specified in the transfer settings. The data is then queued in the Spooler Queue
Manager (see “Spooler Queue Manager” on page 53).
If you perform data acquisition from the Diagnosis view or OQ/PV view, the transfer
NOTE settings are ignored. The analytical raw data is written to the ChemStation data file system
as predefined in the diagnosis or verification methods.
After Acquisition
If you select this check box the data is automatically uploaded to ECM after an
acquisition. The raw data files are written to the local ChemStation file system
while the sequence is still running. When the complete sequence is finished,
the raw data files are compressed to an SSIZip file which is then uploaded to
ECM.
For more information, please refer to “Workflow 1: Acquisition and automatic
upload” on page 63.

ECM Preferences
After Any Data Modification

If you select this check box, the sequence data container is automatically
uploaded to ECM after you changed the data analysis parameters for a sample.
The data is uploaded even if you do not reprocess the sequence.
For more information, please refer to “Workflow 2: Offline review during
acquisition” on page 65.
After Reprocessing
If you select this check box, the sequence data container is automatically
uploaded to ECM each time after you reprocessed the sequence.
For more information, please refer to “Workflow 3: Reprocessing data and
automatic upload” on page 68.
Import after Reprocessing

If you select this check box, a sequence that is only stored locally is
automatically uploaded to ECM after reprocessing.
For more information, please refer to “Workflow 4: Import after
reprocessing” on page 72.
Calculate Peak Performance

This option influences the amount of transferred data. If you select this
option, extended performance values (such as noise or system suitability) are
always calculated, saved to ECM, and can be used in OpenLAB Intelligence
Reporter. If the check box is cleared, the extended performance values are
only available if you choose the ChemStation report styles Performance or
Extended Performance.
For more information, please refer to “Calculation of performance values” on
page 130.

ECM Preferences
Transfer Management Settings

Manage Queue on Connect
If the connection to ECM breaks down for any reason, a running data upload
might be interrupted. In this case, the remaining data is written to an internal
queue.
If you select the check box Manage Queue on Connect, ChemStation tries to
upload the remaining data to ECM each time a connection to ECM is
established (that is, each time a user logs on to ECM from ChemStation).
Alternatively, you can open the Spooler Queue Manager dialog (see “Spooler
Queue Manager” on page 53) at any time with the ECM > Manage Queue
command in the Data Analysis view.
Cleanup Data on Shutdown

If you select this check box, ChemStation checks the local file system at each
shutdown. It deletes all local data and sequence files that are known to be
stored in ECM as well. Methods and sequence templates remain on the local
file system.
If you select the Cleanup Data on Shutdown check box, you should also select the
NOTE Automatic Data Transfer Settings After Acquisition, After Reprocessing, and After Any
Data Modification. Otherwise, if the users forget to upload the data to ECM before closing
ChemStation, data might be lost.
Consider selecting the Cleanup Data on Shutdown check box when the system shall be
NOTE compliant to 21 CFR Part 11. Using this function prevents unauthorized access to the local
data files.
Alternatively, you can open the Data Cleanup dialog at any time with the ECM >
Cleanup Data command in the Data Analysis view.
This dialog box lists all data sets related to ECM apart from the currently
loaded data. The following columns are available:
• Directory: Location of the local file
• ECM Information: ECM server, account information, and LCDF path of the file
in ECM

ECM Preferences
• Last Modified: Date/Time when the copy in ECM was last changed
• Locally Modified: Information whether the local copy has been modified
• Local Version: Version that was downloaded to the local directory
You can now manually select the data sets to be deleted from the local disk.
Alternatively, via a drop down list deselect all data sets, select all, select only
single runs, select only sequence containers, select items older than today, or
items older than a week.
After pressing OK, the local copies of the selected data sets are deleted.
Both automatic cleanup on shutdown and manual cleanup are only possible if
the following conditions are fulfilled:
• the ChemStation user is logged on to ECM
• no other instance of the ChemStation instrument is open
• the spooler queue is empty
If one of these conditions is not fulfilled, automatic cleanup will not be
performed and it is not possible to open the Data Cleanup dialog.
Spooler Queue Manager

The Spooler Queue Manager dialog is opened via ECM > Manage Queue. If you
selected the check box Manage Queue on Connect, and there are interrupted
transfers, the dialog is also opened when you start ChemStation.
With this dialog, you can manage the data transfers from ChemStation to ECM
that were interrupted or could not be started for any reason. Each failed
transfer job is listed in a separate line.
Figure 7 Spooler Queue Manager

ECM Preferences
The following information is provided for each line:

• Description: Information on the version of the data that will be transferred.
Two values are possible:
• Import: No older version of the data exists in ECM at this time. The data
has been newly created and will be uploaded as Version 1.
• Commit: There is already at least one version of the data in ECM. The
version number of the uploaded data will be increased by one.
• Error: Error that disrupted the data transfer. For details on the possible
errors, see “Error Messages in the Spooler Queue Manager” on page 150.
• Queued at: Date when the unsuccessful transfer was queued in the Spooler
Queue Manager.
• Processed last at: Date when the transfer was last attempted.
The toolbar offers you the following commands to manage the queue:
Table 2 Queue management toolbar
Icon Tooltip Description
Process queue Continue processing the transfer jobs. As long as there

is no error, all pending transfer jobs will be processed in
the order as they are shown in the list. This function is
only active if you select the first line in the list.
Stop processing Stop processing the transfer jobs.
Save selected item locally Save the selected lines to a file.

Only the displayed error, description, and dates are
saved to the file. The respective data is not included!
Delete selected item Delete the selected transfer job from the queue. The
concerned data will not be transferred to ECM.
Properties Display the Queue Management dialog box, which

shows details of the items in the queue in either
summary or detailed form.
Refresh view Update the display of the items in the list.
When items are selected from the queue or saved to the local disk, an audit
trail entry will be added to Audit Trail of ECM.

ECM Preferences
When items are deleted from the queue or saved to the local disk, they have not yet been
NOTE uploaded to ECM.
Queue Management Details Dialog Box
The Queue Management Details dialog box is displayed when you click the
tool in the toolbar of the Queue Management dialog box. It shows the
command-specific details of the commands in the Queue Management dialog
box. The Queue Management Details tabs offer two views of the command
details:
• Summary tab
• Details tab
In either tab, the tools in the toolbar allow you to navigate through the
command details:
Displays the details of the first command in the list.
Displays the details of previous command in the list.
Displays the details of next command in the list.
Displays the details of last command in the list.
Summary tab
The Summary tab gives the following summary information about the selected
item:
Command Description The description of the item.
Created The date and time when the item was added to the queue.
Changed The date and time when the item was last processed.
Last Error A description of the error that caused the item to be added to the queue.

ECM Preferences
Details tab
The Details tab gives detailed information about the selected item. You cannot
edit the information in this list. The toolbar provides the following tools:
Sorts the properties by category.
Sorts the properties alphanumerically.
This tool is disabled under all circumstances in the ChemStation.

Remote Data Path as Sequence Parameters
Instead of specifying the Remote Data Path in the Preferences for all acquisition
sequences to be run (see “Remote Data Path” on page 48), the remote data
path can also be set directly in the sequence template. This allows to set up
different remote paths for each sequence without having to modify the
Preferences. The Remote Data Path for a sequence template is set up in the
Sequence Parameters tab.
Figure 8 Sequence Parameters tab of the Sequence Parameters dialog
Use Preferences: When this checkbox is enabled, the Remote Data Path as
specified in the Preferences will be used. Any LCDF path specified in the
Sequence Parameters will be ignored for this sequence. When this checkbox is
disabled, the Remote Data Path will be used as specified when the sequence
template is used for data acquisition.

Path: To specify the Remote Data Path, you need to select a Location and Cabinet
available in the ECM Browser. Click Select Path to select the required path in
an ECM Explorer dialog. For the Drawer and Folder, you can either keep the
selected items, or you can select predefined tokens for an automatic path
creation. When you use the predefined tokens in the Remote Data Path, the
system automatically creates the items if they do not already exist in ECM.
If you use tokens, make sure you have the required ECM privileges to create folders!
NOTE Alternatively, another user who has the required privileges can create the necessary folders
in advance.

Compressed ChemStation File Formats
When ChemStation data is uploaded to ECM, the data is automatically

packaged into an SSIzip file. Depending on the type of data, different
packaging formats are used.
ChemStation data Packaging format Icon in

ChemStation
Single Runs *.D.SSIZIP

(*.d file, ACQ.m and DA.M)
Sequence Container *.SC.SSIZIP

The sequence container contains recursively
the whole sequence data stored in the sequence
subdirectory:
• all *.d files along with ACQ.m and DA.M
• all methods *.m used during acquisition
• batch file *.b
• sequence logbook file *.log
Methods *.M.SSIZIP
Sequence templates *.S or

*.S.SSIZIP
The packaging of ChemStation items is part of ChemStation OpenLAB Option

and cannot be changed manually.
The packaging is automatically carried out when the data is uploaded to ECM.
When the SSIZIP files are downloaded from ECM to ChemStation, they are
automatically unpacked into the according directory in the ChemStation
Explorer.


4
Working With ChemStation OpenLAB
Option
Transferring Data to or from ECM 62
Data-related workflows 63
Workflow 1: Acquisition and automatic upload 63
Workflow 2: Offline review during acquisition 65
Workflow 3: Reprocessing data and automatic upload 68
Workflow 4: Import after reprocessing 72
Workflows for Methods and Sequence Templates 74
Workflow 1: Local files – Save new method 74
Workflow 2: ECM – Save changed method 76
Updating the Local Master Method or Sequence Template 80
This chapter describes the basic workflows with ChemStation OpenLAB

Option. There are four data-related workflows and two workflows for methods
and sequence templates.
Transferring Data to or from ECM
Transferring Data to or from ECM
ChemStation OpenLAB Option provides the ability to open and save different
ChemStation items into their ChemStation contexts:
• Methods
• Sequence templates
• Single run data
• Sequence data
All of this data is stored in ECM as SSIZIP containers (see “Compressed
ChemStation File Formats” on page 59).
When the data is uploaded to ECM, local copies of the files still remain in the
ChemStation file system. If an item is loaded from ECM back into
ChemStation, it is automatically loaded into its original location.
Different options are available regarding the automatic upload of single
run/sequence data to ECM. Loading back stored data from ECM to
ChemStation, however, always requires a manual load action. Methods and
sequence templates require always a manual upload to ECM as well as a
manual load or update into ChemStation.
For downloading data from ECM, several load commands are available in the
ECM menu. Depending on the current view, you can load different files from
ECM. In the Data Analysis view, you can load single run data or sequence data.
These data are automatically set to the status checked out in ECM. In the
Method and Run Control view, you can load methods and sequence templates.
These items are only retrieved and not checked out.
The following workflows are examples that represent typical tasks done with
ChemStation OpenLAB Option.

Working With ChemStation OpenLAB Option 4
Data-related workflows
Workflow 1: Acquisition and automatic upload

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Figure 9 Acquisition and automatic upload
The workflow Acquisition and automatic upload, see Figure 9 on page 63,
illustrates how raw data is uploaded to ECM directly after the acquisition is

finished. The raw data is initially stored locally. After completing the
acquisition, the data is automatically uploaded to ECM.
To save data to ECM automatically after completion of a single run or
sequence:
1 Log in to ECM in an online ChemStation.
2 Load a sequence template.
Your ECM user name is automatically inserted as operator name into the
sequence template.
3 In the Data Analysis view, click View > Preferences.
4 On the Transfer Settings tab, configure the following settings:
• Remote Data Path: Select the ECM location that you want to use for the
sequence data upload.
• Select the After Acquisition check box.
5 Configure the sequence parameters and the sequence table.
6 Start the acquisition.
While the acquisition is running, the raw data, method definition, and a
copy of the sequence template are locally stored on the ChemStation
computer.
After the sequence is finished, all data is automatically uploaded as an
.SC.SSIZIP file to ECM to the previously defined LCDF path. The local copy
of the data remains on the ChemStation computer. The file name of the
sequence container is determined by the settings in the sequence template
(for more details on the sequence template settings, refer to the manual
Understanding Your ChemStation). After uploading the sequence
container the sequence icon in the ChemStation Navigation Pane changes
from to . The LCDF path of the sequence container is shown in the

ChemStation toolbar.
The color of the Sequence Data icon in the Navigation Pane allows to track the
NOTE modification status of the data:
: The sequence container is stored in ECM and has not been modified locally
: The sequence container is stored in ECM and has been modified locally

The upload process may take some time when large amounts of data are uploaded. During
NOTE this time ChemStation is busy and the user cannot perform tasks in ChemStation. Please
wait until the upload is completed.
Workflow 2: Offline review during acquisition

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Figure 10 Offline review during acquisition

The workflow Offline revision during acquisition, see Figure 10 on page 65,
illustrates how raw data is reviewed while the acquisition is still running.
Directly after the acquisition is finished, the original raw data is automatically
uploaded to ECM. After the review, the changed data is again uploaded to
ECM. When the data is uploaded the second time, a new version is created.
To save data to ECM automatically after changing the data:
1 Log in to ECM in an online ChemStation.
2 Load a sequence template.
Your ECM user name is automatically inserted as operator name into the
sequence template.
• Select the After Acquisition check box.
• Select the After Any Data Modification check box.
5 Start the acquisition.
While the acquisition is running, the raw data, method definition, and a
copy of the sequence template are stored locally on the ChemStation
computer.
6 Open an offline ChemStation and change some data analysis parameters for
one of the already finished samples. Save your changes locally.
7 After the acquisition has been finished, two things will happen:
• The original raw data is automatically uploaded as an .SC.SSIZIP file,
Version 1, to ECM to the previously defined LCDF location. The LCDF of
the new sequence is shown in the toolbar in the online ChemStation.
The file name of the sequence container is determined by the settings in
the sequence template (for more details on the sequence template
settings refer to the manual Understanding Your ChemStation).
The sequence icon in the ChemStation Navigation Pane changes from

to .
• The ECM forced upload dialog opens in the online ChemStation. Click OK
to confirm that you finished all work in the offline instance. As soon as

you confirm this dialog, the changed data is uploaded as Version 2 to

ECM.
A local copy of the changed data remains on the ChemStation computer.
For both versions (the one after acquisition and the one from the parallel offline review) the
NOTE ECM operator is the user who has run the acquisition, even if another user has performed
the review in the Offline ChemStation.

Workflow 3: Reprocessing data and automatic upload

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Figure 11 Reprocessing data and automatic upload
The workflow Reprocessing data and automatic upload, see Figure 11 on

page 68, illustrates how data is reprocessed and then automatically uploaded.
This workflow applies to data that has been previously stored in ECM. A new
version of the data is created in ECM for the reprocessed or changed data.

To save data to ECM automatically after reprocessing:

1 Log in to ECM in ChemStation (online or offline).
2 Select ECM > Load Data to download a sequence from ECM.
The ECM Desktop Open dialog opens. Navigate to the ECM folder to load the
data of your choice and select one of the following packaged files:
• Single run data: *.D.SSIZIP files
• sequence data: *.SC.SSIZIP files
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Figure 12 ECM Desktop Open dialog
If the item is checked out, it is marked with a blue or red icon (see
marker 1):
(blue icon): the item has been checked out by you (current user)
(red icon): the item has been checked out by another ECM user
You can load any checked out item. However, if an item has been checked
out by another ECM user, the other user must check in the item before you
can save it back to ECM.
To check out or check in an item, you can use the respective icons available
in the ECM Desktop Open dialog (see marker 2). You can only check out the
latest version of an item.
In order to see more details regarding the type and version of the available
items, select the Detail view (see Figure 12 on page 69, marker 3). To open
an older version of an item, select the Open Revisions command from the

Open menu (see Figure 13 on page 70). This opens the File Versions dialog,
where all available versions of the item are listed (see Figure 14 on
page 70).
Figure 13 Open Revisions command
Figure 14 File versions dialog
3 Select Open in either dialog to download the item to ChemStation.

If the item was not already checked out, it is automatically checked out of
ECM when you load it to ChemStation.

The LCDF path of the data is shown in the ChemStation toolbar.

• Select the After Reprocessing check box.
• Select the After Any Data Modification check box.
6 Modify or reprocess the sequence data.
After the reprocessing is finished, the sequence data is uploaded with its
original name to its original LCDF path. The version number is increased by
one.
The local copy of the reprocessed data remains on the local file system of
the ChemStation computer.

Workflow 4: Import after reprocessing

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Figure 15 Import after reprocessing
The workflow Import after reprocessing, see Figure 15 on page 72, illustrates
how locally saved data is reprocessed and then automatically imported in
ECM.
To save data to ECM automatically after reprocessing:
1 Log in to ECM in an offline ChemStation.

2 From the local file system, open a sequence that has never been saved to
ECM before.
• Select the Import after Reprocessing check box.
5 Reprocess the sequence data.
The data will not be uploaded if you only modify it. You need to reprocess the sequence
NOTE data.
The sequence data is uploaded as a new .SC.SSIZIP file, version 1, to the

previously defined LCDF path in ECM. The file name of the sequence
container is determined by the settings in the sequence template (for more
details about the sequence template settings refer to the manual
Understanding Your ChemStation).
The sequence icon in the ChemStation Navigation Pane changes from to
.
The local copy of the reprocessed data remains on the local file system of the

Workflows for Methods and Sequence Templates
Workflow 1: Local files – Save new method
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Figure 16 Local files - Save new method

The workflow Local files - Save new method, see Figure 16 on page 74,
illustrates how newly created or locally stored methods or sequence template
can be manually uploaded to ECM.
To upload a new method or sequence template:
1 Log in to ECM in an offline ChemStation.
2 In ChemStation, load the method/sequence template or create a new one.
3 In the Method and Run Control view, click ECM > Save Method or
ECM > Save Sequence Template, respectively.
The ECM Save dialog opens.
4 Navigate to the Remote Data Path of your choice to upload the
method/sequence template.
You can only upload items into a Folder, not into a Location, Cabinet, or
Drawer.
5 If necessary, save the item using a different name. the original name is used
by default, but you can modify the name.
6 Click Save.
The Add File dialog opens.
7 Enter a reason for the upload and click OK. The reason is then shown in the
ECM Audit Trail (see “ECM Audit Trail” on page 90).
The progress of the upload is displayed in a window until the item is
uploaded to ECM.
After finishing the upload, the SSIZIP file is available in ECM as version 1.
The file is saved to the Remote Data Path defined in the Preferences (see
“Remote Data Path” on page 48).
The method icon in the ChemStation Navigation Pane changes from to
. The icon for a sequence template changes from to accordingly.

Workflow 2: ECM – Save changed method
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Figure 17 ECM - Save changed method
The workflow ECM - Save changed method, see Figure 17 on page 76,
illustrates how methods or sequence templates that are already stored in ECM
are edited and saved under the same name as a new version.
1 Log in to ECM in ChemStation.
2 Load a method or sequence template.

• Open a method/sequence template from your local PC. Choose a

method/sequence template that has been uploaded to ECM before. ECM
Methods are indicated by , ECM sequence templates by in the

ChemStation Navigation Pane.
– or –
• Select ECM > Load Method or ECM > Load Sequence Template respectively to
download a method/sequence template from ECM.
If you use one of the Load commands, the ECM Desktop Open dialog will open.
Navigate to the ECM folder to load the method (*.M.SSIZIP) or sequence
template (*.S or *.S.SSIZIP) of your choice.
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Figure 18 ECM Desktop Open dialog
If the item is checked out, it is marked with a blue or red icon (see Figure 18
on page 77, marker 1):
(blue icon): the item has been checked out by you (current user)
(red icon): the item has been checked out by another ECM user
You can load any checked out item. However, if an item has been checked
out by another ECM user, the other user must check in the item before you
can save it back to ECM.

To check out or check in an item, you can use the according icons available
in the ECM Desktop Open dialog (see Figure 18 on page 77, marker 2).With
these icons, you can only check out the latest version of an item.
In order to see more details regarding the type and version of the available
items, select the Detail view (see Figure 18 on page 77, marker 3). To open
an older version of an item, select the Open Revisions command from the
Open menu (see Figure 19 on page 78, marker 1). This opens the File Versions
dialog, where all available versions of the item are listed (see Figure 20 on
page 79).
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Figure 19 Open Revisions command

Figure 20 File versions dialog
3 Select Open in either dialog to download the item to ChemStation. In order

to prevent other users from modifying the item, it is possible to select the
Open As Checked Out command to mark the item as checked out from ECM
(see Figure 19 on page 78, marker 2).
Unlike the data files, the methods and sequence templates are not automatically checked
NOTE out of ECM! In order to modify those items in ChemStation, you should check them out from
ECM manually. Otherwise, there is no guarantee that you are working on the latest version.
If the file already exists on the ChemStation computer in the specified

location, you must choose a different download location.
The LCDF path of the loaded method/sequence template is shown in the
ChemStation toolbar in ChemStation.
4 Make some changes to the method/sequence template.
The modified method is indicated by
, a modified sequence templates by in the Navigation Pane.

5 Select ECM > Save Method or ECM > Save Sequence Template respectively to
save the changed method/sequence template.
If you have not checked out the item before loading it from ECM, and another ECM user has
NOTE checked out the item in the meantime, you cannot proceed with the upload back to ECM. A
warning message is displayed, and it is not possible to save the item back to ECM until the
other user has released the checked out item.

6 When the Add File dialog opens, enter a reason for the upload and click OK.
The reason is then shown in the ECM Audit Trail (see “ECM Audit Trail” on
page 90).
The progress of the upload is displayed in a window until the item is
uploaded to ECM.
The .M.SSIZIP/.S file is uploaded with its original name to its original LCDF
path (the path is shown as a tooltip of the method/sequence template in
ChemStation). The version number is automatically increased by one.
Updating the Local Master Method or Sequence Template

If a master method or sequence template is updated in ECM (i.e. a new version
is created), it is possible to update the local copies with the following update
procedure.
1 Make sure the master method or sequence template to be updated is
currently not loaded. The currently loaded method or sequence template is
not available for update.
2 Select ECM > Update Methods ... or Update Sequence Templates ...
Figure 21 Update Methods dialog box
The Update from ECM dialog box is displayed.

The dialog box lists all methods that are connected to ECM. The following
columns are available:

• Name: Path and Name of the local copy of the method/sequence template.
• ECM Information: ECM server, account information, and LCDF path of the
file in ECM.
• Locally Modified: A check box indicating whether the local copy was
modified.
• Local Version: Version number of the local copy of the method/sequence
template.
• ECM Version: Version number of the file in ECM.
3 You can now manually select the methods that are to be updated.
Alternatively you can via the drop down list deselect all methods, select all
methods, select to those methods with a higher version number in ECM, or
select all methods that have been modified locally.
After pressing OK, the selected local methods/sequence templates are
updated with the version in ECM.


5
Administration Regarding
Introduction to 21 CFR Part 11 84
21 CFR Part 11 Requirements 85
General Aspects of Data Security in Computerized Networks – Open
Versus Closed Systems 85
Overview of Configuration Steps Required for Part 11 87
Audit Trails and Logbooks 88
Method Audit Trail 88
Results Audit Trail 89
Report History 90
ECM Audit Trail 90
ECM System Log 92
Administration in ECM 93
Account configuration 93
Users/Groups/Roles 94
Administration of ChemStation Settings 97
ChemStation Administration Tool 97
Electronic Signature 100
Preparation 100
Using electronic signatures 101
This chapter explains the purpose of 21 CFR Part 11 and its implementation in
ChemStation with ChemStation OpenLAB Option.
Introduction to 21 CFR Part 11
Effective August 20, 1997, the U.S. Food and Drug Administration (FDA)
released and published a new rule to enable pharmaceutical companies to
approve their results with electronic signatures and to transfer paper-trail
documentation into electronic records. This rule is known as 21 Code of
Federal Regulations Part 11 (referred to as 21 CFR Part 11) and applies to all
industry segments regulated by the FDA.
The impact of this rule on current work practices and data handling in the
pharmaceutical industry has been much higher than expected. “The industry
wanted to have a rule on electronic signatures, but what they got was a rule
on electronic records.” (Martin Browning, former FDA inspector, during a
validation seminar in Washington D.C.)
21 CFR Part 11 places high emphasis on the implementation of all measures to
protect and secure electronic records. Notwithstanding the uncertainties and
the changes that 21 CFR Part 11 requires in the behavior of both the
pharmaceutical industry and the vendors of chemical analysis equipment, it is
well worth implementing in today’s laboratories because it can help the
industry with one of the most important issues in pharmaceutical
research-bringing new drugs on the market faster.
The major benefits of this shift towards electronic data management are in the
potential productivity increase for the industry. The industry can decrease its
data output on paper, speed up the data review and approval process, and
benefit from new automation technology based on computerized system
control, for example, in manufacturing or dissolution drug release testing.
In addition to this rule on electronic records, other general requirements for
computerized systems are brought to the auditor’s attention. These rules cover
the basic requirements of validation which are limiting data access and
ensuring data integrity and data traceability.
It is, of course, the industry that must ensure that its work practices support
the FDA rules, but most of the requirements also affect the chemical analysis
systems and suppliers of these systems.

Administration Regarding 21 CFR Part 11 Compliance 5
21 CFR Part 11 Requirements

To fulfill the FDA rules and guidelines for compliant electronic records and
computerized systems, it is important to understand the basic aspects of
secure data handling.
• Data security: physical protection of data by limiting access to the system
and preventing unauthorized access.
• Data integrity: protecting raw data and metadata and preventing these
from unauthorized modification, and linking raw data and results to
reproduce the original results at any time, for example, in an audit
situation, and document each new result copy.
• Audit traceability: documenting who did what to the results and when, and
tracing the user adding new reanalyzed versions to the original raw data.
General Aspects of Data Security in Computerized Networks –

Open Versus Closed Systems
Before discussing details of data security in a chromatographic system, some
general aspects of data security in a computerized network need to be
considered.
It is generally known that data transfer over a public network can be accessed
by unauthorized external persons, “hackers”, who gain access either for
personal amusement or intentional fraud.
If an electronic identification comprising user ID and a password is used to
approve confidential or important data, users must be sure that their
signatures are unbreakably linked to the data and that nobody can copy this
signature or get access to the passwords. In a public system, this would
require additional encryption technology, for example, a private/public key
combination of data encryption. In contrast, if a computerized system is
protected from unauthorized access, users can be sure that their signatures
are private and are not accessible to unauthorized individuals.
The FDA also distinguishes between these two scenarios and defines them as
open and closed systems. A public network system can therefore only be
viewed as an open system and a protected network as a closed system, if it
fulfills additional requirements.

In FDA terms, “closed system means an environment in which access is

controlled by persons who are responsible for the content of electronic
records on the system” (11.3.5). The evidence of a system being a closed
system is not a one-time check but an ongoing process of executing and
documenting the system controls that make sure that the system is closed. In
contrast, in an open system, “those persons being responsible for the content
of electronic records do not control the system access.”
As a result, open systems require additional encryption technology for all data
transfer over the network.
ChemStation OpenLAB Option is designed for and supported in closed
systems.

Overview of Configuration Steps Required for Part 11
Overview of Configuration Steps Required for Part 11
If you want to configure ChemStation OpenLAB Option to be compliant with

21 CFR Part 11, you need to go through the following checklist:
• LCDF structure on the ECM Server prepared according to your needs
See “Data Storage in ECM” on page 16.
• ChemStation OpenLAB Option installed on the ECM Server
See “Updating the ECM Database” on page 23.
• ECM Roles/Users/Groups configured
See “Configuring users, roles and privileges” on page 26.
• ECM Account configuration with active audit trail and mandatory reason
See “To enable the ECM Audit Trail” on page 91 and “Account
configuration” on page 93.
• Password policy realized in ECM (including E-mail Notification)
See “To configure the password settings for an ECM Account according to
the password policy” on page 94.
• E-Signatures prepared (messages and privileges)
See “Using electronic signatures” on page 101.
• ChemStation with ChemStation OpenLAB Option and mandatory ECM
login
See “Installing a new ChemStation with ChemStation OpenLAB Option” on
page 29.
• Automatic Data Transfer Settings and Transfer Management Settings
activated
See “ECM Preferences” on page 47.
• Audit trail active for methods and results
See “Method Audit Trail” on page 88 and “Results Audit Trail” on page 89.
• Emergency Plan available, based on options of the Administration Tool
See “ChemStation Administration Tool” on page 97.

Audit Trails and Logbooks
In order to comply to 21 CRF Part 11, ChemStation OpenLAB Option offers

various audit trails and logbooks to document all activities associated with
methods, results, reports, or with ECM files generally. These audit trails and
logbooks track all changes that are made to any file, including data
acquisition, re-analysis, and long-term archiving.
The audit trails are stored in separate files, which are stored together with the
sample or method data. The audit trail files are archived together with the
other data in the according SSIZIP files. The ECM logbooks are available only
directly in ECM.
Method Audit Trail

Each method has a Method Audit Trail. By default, this Method Audit Trail
contains only the comments that you must provide each time when you save a
method. As there is no control on the provided text, there is no guarantee that
the method changes are reproducible.
With regards to 21 CFR Part 11, ChemStation OpenLAB Option makes it
possible to generate a more detailed Method Audit Trail. If the function is
activated, the Method Audit Trail contains not only the user comments, but
also each individual changed parameter with its old and new value. All
changeable data analysis parameters are tracked. This means that you can
reproduce exactly which value has been changed to what, when, and by whom.
To enable the Method Audit Trail for all methods

This is required if you want to comply to 21 CFR Part 11.
1 Select View > Preferences
2 In the Audit Trail Status dialog, select Enable Audit Trail for this method and click
OK.
Once enabled, the Method Audit Trail cannot be disabled.

You can also use the ChemStation Administration Tool to enable the Method Audit Trail for
NOTE all methods (see “ChemStation Administration Tool” on page 97).
To enable the Method Audit Trail only for the currently open method
You can also activate the Method Audit Trail only for one method. This might
be useful, for example, when you finished the development of new method and
want to track all further changes.
1 Select Method > Enable Audit Trail
2 On the Audit Trail tab, select Enable Method Audit Trail for all methods.
To view the Method Audit Trail for the currently open method in
ChemStation
1 Select Method > Method Audit Trail.
To remove the detailed Method Audit Trail

Once a method is enabled for the detailed audit trail, you cannot disable it
again. The only way to get rid of an existing Method Audit Trail is to save the
method under a different method name. In this case, the only hint in the new
method’s audit trail is a comment about the method being based on another
method.
Results Audit Trail

Manual integration events are not saved in the method. Therefore, the Method
Audit Trail contains no information on manual integration events. These
events are only saved in the data file. Nevertheless, they have an influence on
the results. Manual integration events are therefore saved as part of the
Results Audit Trail.
If activated, this Results Audit Trail is added to the existing Data File Logbook
(file name RUN.LOG). By default, the Data File Logbook only contains the
acquisition parameters and reprocessing information for each sample. The
Results Audit Trail additionally tracks the changes of all data analysis
parameters for a sample.

To enable the Results Audit Trail

If you enable the Results Audit Trail, the relevant changes are tracked for all
samples, independent of the sequence they belong to and independent of the
user who carries out the change.
1 Select View > Preferences
2 On the Audit Trail tab, select Enable Results Audit Trail.
To view the Results Audit Trail for the loaded sample in ChemStation
1 In the Data Analysis view, select View > Current Data File Logbook.
Report History
If you create a ChemStation report, you can display the report on the screen,
send it to a printer, or save the report as a specific file (report.pdf). These
report outputs may easily be lost or overwritten, especially when you create
several reports after each other.
With ChemStation OpenLAB Option, ChemStation automatically tracks any
report that was generated. In order to reproduce an old or overwritten report,
select Report > Report History. Here, you can see all reports created for the
current data file since the installation of ChemStation OpenLAB Option. You
can also export or print this history.
ECM Audit Trail

Audit Trail is a record showing who accessed the system and what operations
he or she performed during a given period of time.
You can view file-related, system administration, folder administration, and
scheduler-related entries. For example, you can see when a file was added and
who added it.
For each operation, ECM asks the user for a reason. This reason is also shown
in the ECM Audit Trail. For automatic uploads there are default reasons given
by the system. The reason entry may be optional or mandatory, depending on
the ECM configuration (see “Account configuration” on page 93). If the system

is configured to be compliant to 21 CFR Part 11, providing a reason is

mandatory.
To enable the ECM Audit Trail

You can enable the ECM Audit Trail only for a complete ECM Account. To
activate the ECM Audit Trail, you must select the check box Enable audit trail for
this account when creating a new account.
There is no possibility to activate the ECM Audit Trail afterwards for an
existing account, or to deactivate the ECM Audit Trail again.
If the system shall be compliant to 21 CFR Part 11, the ECM Audit Trail must be enabled.
NOTE
To view the ECM Audit Trail for a specific file

1 In ECM, right-click the respective file and select Properties from the context
menu.
2 In the File Properties dialog, select the Audit Trail tab.
All actions related to this specific file are listed here, together with the
date, ECM user name who performed the action, and a reason provided by
the according user.
To view the ECM Audit Trail for all files

1 In ECM, select the Administration page.
2 In the Navigation Pane, select the Activity Log > Audit Trail node.
All actions related to any ECM file are listed here, together with the file
name, date, ECM user name who performed the action, and a reason
provided by the according user.
You can search the entries, for example, for a specific date or date range, or
for entries related to specific categories (Files, Folders, System, Scheduler,
or Instrument). Also you can print the entries or export them to a file.

ECM System Log

The System Log is a record that shows changes to the system, including
configuration changes, e-mail notifications, and additions or changes of
Locations, Cabinets, Drawers, or Folders.
You can view file-related, system administration, folder administration, or
Scheduler-related entries. For example, you can see when a Location was
added and by whom.
The System Log is always active; you do not need to enable it.
To view the ECM System Log

2 In the navigation pane, select the Activity Log > System Log node.
All general actions related to ECM are listed here, together with the date,
ECM user name who performed the action, and a reason provided by the
respective user. Depending on the ECM Account administration, the reason
may be optional or mandatory (see “Account configuration” on page 93).
You can search the entries, for example, for a specific date or date range, or
for entries related to specific categories (Files, Folders, System, Scheduler,
or Instrument). Also you can print the entries or export them to a file.

Administration in ECM
When you install ChemStation OpenLAB Option, you need to carry out certain
basic configuration tasks in ECM (see “Installation and Configuration Tasks
on ECM Server” on page 23). In addition, there are several other settings in
ECM that are relevant with regard to 21 CFR Part 11. These settings are
described in the following section.
Account configuration
To configure the ECM Account
2 In the Navigation Pane, select the Account Administration node.
3 Double-click the Configuration item.

Setting Description 21 CFR Part 11 Requirements
Lockout If a user tries too often to log in with You should limit the number of
invalid user credentials, he is locked out allowed login attempts to
of the system and cannot log in any three.
more – not even with valid user
credentials. You can define the number
of allowed login attempts.
Inactivity Timeout If a user does not perform any action in You should specify a timeout.
ChemStation for the given period of
time, he is automatically logged out. The
same applies to the ECM Web Client.
System administrator The e-mail address you provide here will You should provide an e-mail
email automatically be notified when a user address.
was locked out after too many
unsuccessful login attempts.
Minimum Password If users change their passwords, they You should require a minimum
Length must choose a password with at least password length of at least 5
the given number of characters. The characters.
default setting is 5.
Require entry in In each ECM Audit Trail or System Log The ECM Audit Trail and
Reason fields entry the users can enter a specific System Log reasons must be
reason for the action. If this check box is mandatory.
selected, the entry is mandatory.
Users/Groups/Roles
To configure the password settings for an ECM Account according to the
password policy
21 CFR Part 11 requires that company/the laboratory has a password policy.

NOTE

2 In the navigation pane, select the Account Administration node.
3 Double-click the Users/Groups/Roles item.


21 CFR Part 11 does not define any specific rules for the password settings.
However, your company must have defined a password policy. You may
consider the following settings:
• User cannot change password
• User must change password after next login
Note that the minimum password length is defined in the ECM Account
configuration (see “Account configuration” on page 93).

Roles and folders

ECM allows you to assign specific roles to users or user groups. This can be
done at the global level for the entire ECM Account, or individually for specific
folders. For example, a specific user group may have the Contributor role for
folder A, but at the same time have only the Reader role for folder B.
Preparations If you want to assign roles at the folder level, you must first enable this feature in ECM. The setting is
valid for the complete ECM Account.
To enable roles for folders:

3 Double-click the Users/Groups/Roles item.
4 On the Roles tab, select the required role and click Edit.
5 Select the Available in folder access tab check box.

Administration of ChemStation Settings
ChemStation Administration Tool

The ChemStation Administration Tool offers a number of functions which are
helpful if the ECM Server is down and the connection from the ChemStation
client to the ECM Server is lost. As one of these functions is to switch off the
mandatory ECM login, the access to the ChemStation Administration Tool is
strictly limited. The ChemStation Administration Tool can only be started by
users who are a member of the local user group CSAdministrators (see “Enabling
users to start the ChemStation Administration Tool” on page 34).
To start the ChemStation Administration Tool:
1 From the Start menu in the Task Bar, select Start > All Programs > Agilent
ChemStation > ChemStation Administration Tool.
Figure 22 ChemStation Administration Tool

Login options
The following check boxes are relevant in case of an emergency, that is, if the
ECM Server is down:
• Mandatory Login: If you clear this check box, all ChemStation instances on
this client can be started without an ECM login. If the ECM login used to be
mandatory and the ECM Server is down, clearing this check box can be
used to make ChemStation accessible again.
Be aware that, as a consequence, the privileges of the ChemStation users are now
NOTE unlimited. The users have access to all ChemStation functions.
• Start ChemStation when ECM is unavailable: If you select this check box, the
ChemStation can be started when the ECM server is unavailable even if
Mandatory Login is enabled. The Login dialog at startup of ChemStation can
be cancelled. With this option selected, any user can continue to work in
ChemStation in case the server is down without contacting a user who has
access to the Administration Tool.
Be aware that, as a consequence, the privileges of the ChemStation users are now
NOTE unlimited. The users have access to all ChemStation functions.
• Break Session Lock: If you select this check box, a locked ChemStation can be
accessed by any user just by clicking Cancel in the Login dialog. If a
ChemStation is currently locked and the ECM Server is down, selecting this
check box is the only possibility to regain access to the current
ChemStation session.
Be aware that, as a consequence, the user who regained access to ChemStation now has
NOTE unlimited access to all ChemStation functions.
The following check boxes allow you to configure the timebased session lock
and the ChemStation toolbar Lock Button:
• Timebased session lock locks private: If you select this check box, the time
based session lock will lock the ChemStation sessions privately. Otherwise,
the timebased session lock will be non private.

• Toolbar Lock Button locks private: If you select this check box, the ChemStation
toolbar lock button will lock the ChemStation session privately. Otherwise,
a non-private lock will be applied.
Data Handling and Audit Trail Configuration

The ChemStation Administration Tool offers to conveniently configure all
ChemStation instances on a client at the same time with the same settings. By
default, the option Use instance specific settings is selected, so that the settings
are not overwritten.
To change the settings for all ChemStation instances
1 Select the option Use these settings for all instances on this computer.
2 Select the required check boxes. The settings are the same as in the
Preferences dialog (see “ECM Preferences” on page 47).
3 Click OK.

Electronic Signature
Electronic signatures provide a means to sign documents as equally binding as

a handwritten signature. In addition, electronic signatures are reproducible,
because they are recorded in a secure, time stamped audit trail. Manipulation
is prevented by enabling only users with specific privileges to sign
electronically.
An electronic signature contains the user name (full name), date, and time
when the signature was applied, the location where the signing occurred, and
a user-configurable definition associated with the signature. The signature is
always related to the complete SSIZIP container, not to a single file inside the
container.
CFR 21 Part 11 requires that companies, especially ones that employ any type
of approval process, use electronic signatures. With the help of the Agilent
OpenLAB Business Process Manager (BPM) module, you can create highly
automated review or approval processes including e-mail notification.
Preparation
Privileges
An ECM user needs to have the privilege Content: File Signatures in order to be
able to sign electronically. This privilege is, for example, assigned to the ECM
default role: :Approver.
Reasons for the signature

With each signature the ECM users must either select a given reason or, if they
are allowed to, provide their own reason.
To configure the reasons for signatures:
3 Double-click the Electronic Signature item.


4 To provide a new reason, enter the required text into the Reasons field and
click .
5 To delete an existing reason, select the reason in the Default reasons list and
click .
6 If you want to allow users to provide their own reason with a signature,
select the User can specify reason check box.
If you clear this check box, the users can only select one of the given default reasons.
NOTE
7 If necessary, adjust the timeout settings:

• The Signature screen timeout defines, how long an e-signature dialog will
stay open if no signature is submitted. The default setting is 5 minutes.
• The Consecutive signature timeout is relevant if an ECM user carries out
several successive e-signatures. If the next e-signature takes place within
the given timeout interval, the location and the reason provided in the
first e-signature will be pre-filled in the next dialog. The default setting
for the consecutive signature timeout is 5 minutes.
Using electronic signatures

To apply an electronic signature
1 Right-click the required SSIZIP container and select Electronically Sign >
Electronic Signature from the context menu.
The Electronic Signature dialog opens.
The other command in the context menu, Electronically Sign > Acrobat Plug-In
NOTE Signature, works only for PDF documents and only if you purchased the according plugin. It
enables you to add signatures directly inside PDF documents.
2 Enter your ECM user credentials (username, password, and domain).

3 Enter your current location. With this information, the location from where
you provide the signature is reproducible.
4 Select a reason for the signature from the Default reason drop-down list.
- Or -
Select the User specified check box and enter a different reason into the text
field. Note that this option is only available if the ECM Account is
configured accordingly.
5 Click Sign.
The file is now signed electronically. The e-signature is shown in the file
properties in the eSig tab. The e-signature is also included in the ECM Audit
Trail.
To view electronic signatures

The user preferences in ECM can be configured in such a way that the number
of e-signatures applied to a file is shown by default in the ECM content display,
together with the file name and status.
The electronic signature itself is shown in the file properties in the eSig tab,
and it is also part of the ECM Audit Trail.
To adjust the user preferences:

3 Double-click the User Preferences item.
4 Click Modify... to modify the column settings.
5 Select # of signatures and click to add this property to the selected

columns.
6 Click OK.
The number of e-signatures is then shown on every content page in ECM.

6
Custom Fields
About Custom Fields 104
Setting Up Custom Fields 105
To define new custom fields 105
To import custom fields from an existing method 107
Specifying Custom Fields Values 108
To provide sample custom fields values 108
To provide compound custom fields values: 109
Reporting of Custom Fields 110
To display custom fields in ChemStation reports 110
Reprocessing with Custom Fields 112
This chapter explains the purpose and usage of custom fields in ChemStation.

6 Custom Fields
About Custom Fields
About Custom Fields
ChemStation provides numerous fields in which you can enter information on

a sequence, specific samples, or the expected compounds. These fields are
sufficient for many standard analysis tasks. However, for some specific tasks
you may need to save additional information on the samples or compounds. In
this case, you can define the so-called custom fields.
Custom fields are available for sample information and for compound
information. The custom fields definition is saved as part of the method
definition. When you define custom fields, you can define a suitable field
name and data type for the additional information, according to your needs.
After you have defined the custom fields, you can enter the actual values in
the sequence table of the current sequence. These values will be shown on
ChemStation reports and are available also for OpenLAB Intelligence reports.
In OpenLAB Intelligence reports, the values can even be used for calculations
or statistical evaluations.
In addition, you can use custom fields to flag all samples related to a specific
project or study. This flag is then used by OpenLAB Intelligence Reporter to
find all results related to this specific project or study.

Custom Fields 6
Setting Up Custom Fields
The custom fields definition is part of the method. You can define up to ten
custom fields related to the samples, and up to ten custom fields related to the
compounds. Also, you can import the custom fields definitions from another,
existing method.
To define new custom fields

1 Select the Method and Run Control view.
2 Load the required method.
3 Select Method > Custom Fields Setup.
The Set up Custom Fields definitions dialog opens. It contains two sections, one
for sample custom fields, and one for compound custom fields.

6 Custom Fields
Figure 23 Set up Custom Fields definitions dialog
4 Click to add a new custom field in the according section.

5 Enter a suitable name for the new custom field (for example, Color).
If you create sample custom fields named Project or Study, these custom fields will be
NOTE reported twice in the .acaml file: in the regular custom fields section, and also in the
projects/study mapping. This enables OpenLAB Intelligence Reporter to find all results
related to a specific project or study.
6 Select a suitable data type (for example, TEXT).

7 If appropriate, enter a default value (for example, Blue).
8 If appropriate, select the Mandatory check box to ensure that the custom
field is always filled.
If you make a custom field mandatory, you should also provide a default
value.
9 If required, click to delete a selected custom field.

Custom Fields 6
10 If required, adjust the order of the custom fields with the Up and Down
buttons.
To import custom fields from an existing method

1 Make sure the method with the custom fields is available in your local file
system.
2 Load the target method (the one to which you want to import the custom
fields definition).
3 Select Method > Custom Fields Setup.
4 Click Import. A dialog opens where you can select the source method from
the local file system.
5 Click OK.

6 Custom Fields
Specifying Custom Fields Values
The specific values of the predefined custom fields depend on the actual
sequence. Therefore, the values are specified in the sequence table.
To provide sample custom fields values

1 In the Method and Run Control view, load the required sequence.
2 Select Sequence > Sequence Table to open the sequence table.
3 Click Custom Fields.
The Set up Custom Fields values dialog opens. The Sample Custom Fields tab is
active. Each predefined custom field is shown in a separate column.
Mandatory custom fields are marked with (*) in front of the field name.
The lines correspond to the lines in the sequence table.
Figure 24 Set up Custom Fields values - Sample Custom Fields
4 Enter the required values for each sample and custom field.
You can only start a sequence after the mandatory fields have been completed.
NOTE

Custom Fields 6
To provide compound custom fields values:

1 Select the Compound Custom Fields tab.
Figure 25 Set up Custom Fields values - Compound Custom Fields
This tab is only available if compounds have been set up in the method's calibration table.
NOTE
2 Select the required compound from the drop-down list at the top, or click
, , , or to navigate to the required compound.
3 Enter the required values for each sample and custom field.
4 Select the other compounds and provide the values accordingly.
5 Click OK.

6 Custom Fields
Reporting of Custom Fields
Custom fields values are always saved to ECM and are therefore always
available in OpenLAB Intelligence Reporter. However, they are not
automatically shown in ChemStation reports. If you want to display the
custom fields in your ChemStation reports, you must first adjust the report
options.
To display custom fields in ChemStation reports

1 Select the Data Analysis view.
2 Select Report > Specify Report.
3 Select the check boxes Add Sample Custom fields to Sample info and Add
Compound Custom fields.
4 Click OK.
The custom fields and the according values are then displayed on
ChemStation reports (see examples below).
Figure 26 Sample custom fields

Custom Fields 6
Figure 27 Compound custom fields

6 Custom Fields
Reprocessing with Custom Fields
Reprocessing with Custom Fields
It is possible to modify the values of the custom fields during reprocessing.

When you prepare the reprocessing, you can edit the custom fields values in
the Sequence Table in the Data Analysis view. For more information on
editing custom fields values, see “Specifying Custom Fields Values” on
page 108.
After an acquisition, you can only edit the values of existing custom fields,
that is, custom fields that were defined in the method used for the acquisition.
You can not add new custom fields afterwards, even if the method used for
reprocessing contains different custom fields than the original method.

7
Treatment of ChemStation Legacy Data
and Data Migrated from ChemStore
Introduction 114
Result set Migration 115
Conversion of Data Migrated from ChemStore 117
This chapter provides information on migrating legacy ChemStation sequence

data to sequence container format, in order to be able to upload these data sets
to ECM.

Introduction
Introduction
When ChemStation OpenLAB Option is installed, Unique Folder Creation can not
be switched off. All sequence data sets that are acquired are therefore stored
as sequence container. Please refer to the manual “Getting Started with New
ChemStation Workflow” for more details on working with Unique Folder
Creation.
The sequence container format of sequences is essential for upload to ECM.
Therefore ChemStation legacy sequence data acquired with ChemStation
prior to B.02.01 or while Unique Folder Creation was off, have to be migrated to
sequence container format before they can be uploaded to ECM.
Legacy ChemStore data that have been migrated to ECM can also be converted
to be reviewed in the Navigation Table.

Treatment of ChemStation Legacy Data and Data Migrated from ChemStore 7
Result set Migration
ChemStation provides a tool to migrate non-result set data to result set

format. To successfully perform this task, it is required that the original
sequence file is still available. It must contain all the necessary sequence lines
and follow the original data file naming scheme to reprocess all the data files
of the sequence. In addition, all the methods in the Method column of the
sequence table have to be available.
To perform migration,
start the Result Set Migration from the Sequence menu in Data Analysis view.
Figure 28 Result Set Migration
Fill in the following required fields:

Select Sequence Template: Select the sequence file (*.S) that contains the
sequence table that matches the data set to be migrated.
Select Method Path: Select the directory where the methods are located that are
referenced in the sequence table.
Select Source: Select the directory that contains the data files to be migrated.

Select Destination: Specify the path and name of the result set to be created. You
may select an existing folder or create a new one.
When all fields are filled in, the migration can be started.
The following steps will be performed:
• The result set directory will be created.
• The sequence template will be copied to the result set. It will also be
converted to a state where it is able to reprocess data files in Data Analysis
view.
• The methods referenced in the sequence table are copied from the specified
method path to the result set folder.
• The data files, the sequence logbook, and the batch file are copied from the
data source directory to the destination directory.
• According to the information in the sequence table, a copy of the
corresponding method is copied to each data file as DA.M.
When the result set migration is completed, a success message is displayed in
the Messages and warnings field. Otherwise a warning message indicates any
problem during migration. Details about the warning can be obtained by
double-clicking the warning message.

Treatment of ChemStation Legacy Data and Data Migrated from ChemStore 7
Conversion of Data Migrated from ChemStore
When ChemStore sequence data have been migrated to ECM, they are already
available in the form of .sc.ssizip files and thus ready to be downloaded into
ChemStation Data Analysis view. However, such sequence containers have to
be converted to be ready for review in the Navigation Table.
The conversion process is started automatically after downloading the data
from ECM:
1 Select ECM > Load Data and select the data set you want to view in
ChemStation.
A message is displayed that the sequence data will be reprocessed. Press Yes
to continue.
If you press No, the local copy of the data set will be deleted immediately.
NOTE
2 When asked to save the sequence file, press Yes.

In order to prevent printing reports for the reprocessing step for
conversion, the Sequence Output settings of the sequence are changed in the
following way:
• Print sequence summary report: on
• Report to printer: off
• Report to file: off
• Report to PDF: off
• Report to HTM: off
• Print individual report for each run as well: off
3 Now you can review or reprocess the sequence data.

If the sequence container is uploaded to ECM after conversion (either

automatically after reprocessing or manually), the new versions of the
sequence can be loaded into ChemStation without further conversion steps
later on.

8
Interface to OpenLab Intelligence
Reporter
Introduction 120
Prerequisites 122
Typical reporting workflows 122
To create a Single Sequence OpenLAB Summary Report 127
Interface Components Concerning OpenLAB IR 128
Template selection in Sequence Output 128
Automatic Creation of OpenLAB Intelligence Report at the End of the
Sequence 129
OpenLAB IR commands in the ECM menu 129
Calculation of performance values 130
This chapter provides information on the integration of OpenLAB Intelligence

Reporter in Agilent ChemStation.

Introduction
Introduction
Agilent OpenLAB Intelligence Reporter provides advanced reporting

functions for any chromatographic data generated by Agilent ChemStation or
Agilent OpenLAB ICM. The reports are based on the standardized ACAML 1.1
or 1.2 data, which is automatically generated by ChemStation (B.02.01.SR1 or
higher, with ChemStation OpenLAB Option).
OpenLAB Intelligence Reporter enables you to generate knowledge by creating
various types of intelligent reports:
• Sequence reports with summary calculations and statistics
• Reports of complex tests with condensed information, for example by
visualizing key results or by presenting trend charts
• Reports presenting decision-based results (for example, with flagged
outliers, or with results automatically sorted by pass/fail criteria)
You can either use OpenLAB Intelligence Reporter to report the results
currently shown in ChemStation, or you can define the required data in the
Reporter Client.
For more detailed information on OpenLAB Intelligence Reporter, please see the OpenLAB
NOTE Intelligence Reporter documentation.
ACAML version
ChemStation stores all data in the ACAML format (ACAML = Agilent Common
Analytical Markup Language), which results in .acaml files. There is one
.acaml file for each sequence or single run. When the data is uploaded to ECM,
the .acaml file is part of the SSIZIP sequence container. OpenLAB Intelligence
Reporter uses the data provided in these .acaml files.
In ChemStation B.04.02, the ACAML schema is updated from version 1.1 to
1.2. This version 1.2. of the ACAML schema is only supported by OpenLAB
Intelligence Reporter revision A.02.01.

Interface to OpenLab Intelligence Reporter 8
Introduction
Data flow - example

When using ChemStation together with ECM and OpenLAB Intelligence
Reporter, data is transferred at different times from the ChemStation client to
the ECM Server and back. There are several possible scenarios for the data
flow, depending on the workflow you follow.
As an example, the following figure shows the data flow for creating a single
sequence report.
Figure 29 Example: Data flow for creating a single sequence report
1 In ChemStation:
• You select a report template for the OpenLab Intelligence Reporter in the
Sequence Output.
• If the report is to created automatically at the end of the sequence, you
select Preview at end of sequence in the Sequence Output.
• You select the Automatic Data Transfer Setting After Acquisition.
• You start the sequence.
2 After the acquisition, all data is automatically transferred to ECM.
3 The result data and metadata is automatically extracted from the .acaml
files into the Reporting Database.
4 In ChemStation: You trigger the creation of the report by clicking Create
OpenLAB Intelligence Report. If Preview at end of sequence was selected in the
Sequence Output, the report is created automatically without additional
user interaction.

Introduction
5 The previously selected report template is automatically applied to the new

sequence data. The resulting report is transferred to the ChemStation client
computer.
6 The resulting OpenLAB IR report is shown in ChemStation.
Prerequisites
If you want to use OpenLAB Intelligence Reporter, the following prerequisites
must be met:
• OpenLAB ECM is installed.
• OpenLAB Intelligence Reporter is installed.
• ChemStation OpenLAB Option is installed.
• The chromatographic data has been uploaded to ECM.
Typical reporting workflows

Depending on the scenario, there are different workflows when working with
OpenLAB Intelligence Reporter. Typically one of the following workflows
applies:
• Single Sequence OpenLAB Summary Report (see “To create a Single Sequence
OpenLAB Summary Report” on page 127)
A single sequence is acquired in ChemStation, and the data is reviewed in
ChemStation first. The OpenLAB summary report is created for this single
sequence only.
• Multiple Sequence Summary Report
Multiple sequences are acquired over time (days to weeks). A user
subsequently searches for these sequences, and creates a summary report
for the selected sequences.
• Study/Project Summary Report
A large number of sequences (10’s to 100’s) are acquired over time (weeks
to months). A user searches for all data for these sequences and creates a
complex study summary report based on these data.

Introduction
Only the Single Sequence Summary Report can be directly generated from ChemStation.
NOTE For the other two reporting workflows, you need to perform all tasks in OpenLAB
Intelligence Reporter. See the OpenLAB Intelligence Reporter documentation for more
details.
When printing an Intelligence Report directly in the ChemStation only a report based on the
NOTE latest version of the data can be created. For reports based on earlier versions the report
template has to be modified, or the report has to be created in the OpenLAB Intelligence
Reporter software.
Example reports
The reports generated by OpenLAB Intelligence Reporter can include a wide
variety of information, such as:
• Custom calculations (e.g. summary calculations, statistics, and complex
tests)
• Decision-based result presentation (flag outliers, automatically sort results
by pass/fail criteria, etc.)
• Search-based report content selection
• Condense information by visualizing key results (e.g. in trend charts)
In addition, interactive reports can be based upon specific parameters, such
as a date range, or the reports can contain expandable detail information.
See the following figures as an example.

Introduction
Figure 30 Multi-sequence summary report
(1) Report header with company logo
(2) Sequence information
(3) Sequence table
(4) Results for calibration standards

Introduction
(5) Statistical calculations
(6) Results for quality control samples, grouped by sample name
Figure 31 Interactive column usage report
(1) User parameters (here: Start Date and End Date) as selected by the user
(2) Expandable detail information

Introduction
Figure 32 Cross sequence statistics with trend chart
(1) Expandable detail information on each sequence
(2) Overall statistics
(3) Trend chart

Introduction
To create a Single Sequence OpenLAB Summary Report

1 Prepare the data in ChemStation. There are different ways of preparing the
data (see “Data-related workflows” on page 63). For example, run a
sequence with the Transfer Setting After Acquisition.
Make sure the data has been uploaded to ECM.

NOTE
2 In the Data Analysis view, load the relevant data set.

3 Under Sequence > Sequence Output, select a suitable OpenLAB IR template.
4 Select ECM > Create OpenLAB Intelligence Report.
The resulting OpenLAB IR report is opened with the data of the current
sequence.

Interface Components Concerning OpenLAB IR
If OpenLAB Intelligence Reporter is installed, several new interface

components are available in ChemStation. These components are described in
the following.
Template selection in Sequence Output

Under Sequence > Sequence Output, you can select an OpenLAB Intelligence Report
Template for the currently loaded sequence. This setting is optional.
• If you select a specific report template:
When you create a report, OpenLAB Intelligence Reporter automatically
uses the given report template. The resulting report is shown in OpenLAB
Intelligence Reporter without any further inquiry.
• If you do not select any specific report template:
When you create a report, OpenLAB Intelligence Reporter opens with the
relevant data already selected, but without applying any specific report
template to the data. You must open a suitable report template manually in
the OpenLAB IR Reporter Client.
On an ECM installation with multiple accounts, projects from all accounts are visible in the
NOTE Projects menu of OpenLAB Intelligence Reporter! Ensure that you select a project
belonging to the ECM Account you are working on.
This is not an issue when selecting a template directly from ChemStation, as you select the
template from the LCDF structure of the specific ECM Account you are working on.
Depending on the options selected in the OpenLAB IR Reporter Client, the

report is either generated automatically after loading the template or must be
generated manually.
The link to the selected report template is stored in the sequence parameters.
Thus, when you create the report the next time, the report template will be
automatically applied.

You can select a different report template in OpenLAB Intelligence Reporter at

any time. The setting in the Sequence Output in ChemStation is only used as a
default setting.
Automatic Creation of OpenLAB Intelligence Report at the End of

the Sequence
Under Sequence > Sequence Output, you can select Preview at end of sequence for
the currently loaded sequence template. This setting is optional. It requires
that an OpenLAB Intelligence Report Template is also selected.
With this setting enabled, the OpenLAB Intelligence Report will be created
automatically at the end of sequence acquisition or sequence reprocessing
based on the selected template.
OpenLAB IR commands in the ECM menu

In the ECM menu, there are two commands related to OpenLAB Intelligence
Reporter:
• Start OpenLAB IR
This command opens OpenLAB Intelligence Reporter. No data is passed

from ChemStation to the Reporter Client. You can select the required data
directly in the Reporter Client.
• Create OpenLAB IR Report
After acquiring or reprocessing sequence data, you can create a report in

OpenLAB Intelligence Reporter as soon as the data has been uploaded to
ECM. The report is based specifically on the current sequence, that is, the
sequence that is currently loaded in the Data Analysis view in ChemStation.

You must first upload the sequence data to ECM before you create a report. Only data that
NOTE is available in ECM can be used by OpenLAB Intelligence Reporter to generate a report.
Calculation of performance values

In ChemStation, certain specific values, such as noise and peak performance
values, are not necessarily calculated and uploaded to ECM. If these values are
not uploaded to ECM, you can not use them in your reports.
Under ECM > Preferences, there is the check box Calculate Peak Performance. This
check box is cleared by default.
• If you select Calculate Peak Performance:
Values such as noise and peak performance values are always calculated.
They are uploaded to ECM together with the other sequence data. You can
use the values in your reports.
• If you do not select Calculate Peak Performance:
Values such as noise and peak performance values are only calculated if
you choose the ChemStation report styles Performance or Extended
Performance. As a consequence, there is no guarantee that these values
always exist in ECM, and you can not generate reliable OpenLAB IR reports
containing this type of information.

9
Attribute Extraction Services for
ChemStation Data
ACAML Filter 135
ChemStation XML Attribute Extraction Service 136
ChemStation Filter 137
This chapter provides an overview of the available ECM Attribute Extraction

Services (AES) for ChemStation data. The AES extract metadata information
from the ChemStation data files. These metadata make the ChemStation data
searchable. For detailed information, refer to the ECM documentation.

Attribute Extraction Services for ChemStation Data
ECM Attribute Extraction Services (AES) provides the following AES for the
extraction of metadata from ChemStation data files:
• The ChemStation XML filter extracts peak, compound and result data from
the result.xml file generated by the XML export routine in ChemStation
revision A.10.02 and later.
• The ChemStation filter extracts basic sample and run data from the header
of the channel files (*.ch), *.uv and *.txt files generated by all ChemStation
revisions.
AES need to be installed by an ECM Administrator on the ECM Server; in
addition, the filters need to be enabled for the system. The keys of an AES that
are to be applied to a ChemStation file need to be selected for the respective
LCDF structure. These are ECM administration tasks, and are described in the
Enterprise Content Manager Administrator’s Guide and the ECM online help.
The metadata can be queried using various search types in ECM. The ECM
Search functionality is also available within ChemStation. When opening a file
from ECM, the ECM Open dialog allows you to search for files of interest using
the ‘magnifying glass’ icon, see Figure 33 on page 133.
Using the Quick Search, you can search through various alphanumeric fields
by entering a search key, such as an operator name. On the upcoming search
page, you select the Advanced tab where, depending on the enabled filter
packages, various keys are enabled, see Figure 34 on page 133.

Figure 33 Search options
Figure 34 Filters available in search options
In the Search dialog, you can specify the available keys, and it is possible to
define a search expression by combining two or more of the available keys
using boolean operators. For detailed information regarding the use of the

various search algorithms, refer to the online help of your ECM system or the
Enterprise Content Manager Administrator’s Guide, as well as the AES-related
manuals.

ACAML Filter
ACAML Filter
The ACAML Filter extracts information from the ACAML files that are also
used for the OpenLAB Intelligence Reporter (see “Interface to OpenLab
Intelligence Reporter” on page 119. The ACAML files are always created when
acquiring or reprocessing data when the OpenLAB Option is installed.
Please note that the ACAML filter is only available for ECM 3.3.2 SP1.

ChemStation XML Attribute Extraction Service
ChemStation XML Attribute Extraction Service
The AES for ChemStation XML extracts key information from the following
categories of the result.xml generated by ChemStation Rev. A (revision A.10.02
and later) and ChemStation Rev. B (revision B.01.01.and later) per data file.
Note that ChemStation must be configured to generate the result.xml file, see
the ChemStation XML Connectivity Guide.
• Acquisition (for example, instrument name, method information)
• Chromatogram (for example, derivative order, detector name)
• Custom
• Module
• Peaks (for example, peak name, amount, retention time, compound name)
• Sample (for example, calibration method, LIMS ID)
• Signal/noise

ChemStation Filter
ChemStation Filter
The AES for ChemStation extracts attributes from *.ch, *.uv, and *.txt files
created by the 16-Bit ChemStation (Rev A.x.x) or 32-Bit ChemStation (Rev
B.x.x). It extracts key information from the header of ChemStation *.ch and
*.uv data files (for example, sample name, method file, instrument model).
From the report.txt file, it extracts key information (for example, sample
name, acquisition method, analysis method). In addition, the service extracts
information on support files from the category Content.
An ECM Scheduler Add-in for Agilent ChemStation enables the ECM
Scheduler to automatically upload data generated by ChemStation to ECM.

ChemStation Filter

10
Using Print Services in ChemStation
ECM Print Services 140
Setting Up ECM Print Services 141
Installing ECM Print Services 141
Configuring ECM Print Services for use with Amyuni PDF Converter 142
To set the printer to ‘unattended mode’ 143
Configuring ECM Print Services - Adobe Distiller 144
To set the printer to ‘unattended mode’ 145
Working with ECM Print Services in ChemStation 146
This chapter gives a brief overview of how to install and configure the Print
Services. This enables you to automatically upload ChemStation reports to
ECM in a PDF format.

ECM Print Services
ECM Print Services
ECM Print Services are print management systems that transfer human
readable electronic documents to ECM. They can be used to print ChemStation
reports to ECM in PDF format.
When you add and configure a print service, it appears as an available printer
on your computer. When you print with ECM Print Services, a PDF file is
created and automatically uploaded to the ECM system. In addition, you can
also set up the system to print additional hard copies to a conventional
printer.
ECM Print Services can be installed for ECM Server revision 3.3.1 or later.
The ECM Print Service consists of two components:
• The ECM Print Service Manager, where you add and manage printers for
the ECM Print Service.
• The ECM Print Service, which monitors a folder on your local disk drive.
When a print service receives a print job, the print driver prints to a file in
the monitor folder. Then the ECM Print Service intercepts the file and
uploads it to ECM. In order for a file to be uploaded to the ECM program, it
must have the file extension *.pdf.

Using Print Services in ChemStation 10
Setting Up ECM Print Services
Setting Up ECM Print Services
Installing ECM Print Services

The installation and setup of ECM Print Services requires following steps. The
installation details are given in the ECM Print Services documentation.
1 Connect to the ECM Server revision 3.3.1 and select the Administration tab.
2 In the Download section of the Administration tab, select ECM Print Services for
ECM and run the installation. Follow the instructions given by the
installation wizard.
3 After the installation, the ECM Print Services icon is available in the task
bar and the Amyuni PDF Convert is available as printer (see Start > Settings
> Printers and Faxes > Amyuni PDF Converter).
4 Double-click the ECM Print Services icon. The ECM Login dialog opens.
5 Enter the required user credentials and click Login to proceed for
configuration.

Configuring ECM Print Services for use with Amyuni PDF Converter
Configuring ECM Print Services for use with Amyuni PDF

Converter
1 Create a monitor folder on your ChemStation ECM Client system. The

folder should not be placed in the Chem32 directory.
2 Right-click the ECM Print Services icon in the task bar and select Configure
Printers.
Figure 35 ECM Print Service icon
3 Log on to the ECM Print Services.

4 Select the Add Printer icon to add a printer with the following details:
• Type: PDF Converter
• Name: Specify a unique name, e.g.
Chem1 Print
• Define the printer security options in accordance with your
organization’s security policies.
5 Click Add to continue. Depending on your PC configuration, a message
regarding the Browse for Folder dialog is shown. Exit that message with OK.
6 In the upcoming Browse for Folder dialog, select the monitor folder for the
ECM print service.
7 The printer has now been created successfully and is available in the ECM
Service dialog.
8 Right-click the ECM Print Service icon in the task bar and select Configure
Printers, see Figure 35 on page 142.
9 Open the printer configuration by marking your specific printer and select
the Configuration tab. For details, refer to the ECM Print Services online
help.
• ECM: you need to specify the ECM (LCDF) data path where the uploaded
files will be stored after transfer.
• Settings: Transfer-specific settings.

Configuring ECM Print Services for use with Amyuni PDF Converter
• Hardcopy Printers: It is also possible to get a hardcopy printout.

• Email: It is possible to enable e-mail notification.
10 Click Apply to apply the configuration to the ECM Print Service and leave
the dialog box with OK.
11 Leave all printer-related dialog boxes with OK.
12 In ChemStation, it is now possible to specify the newly configured printer
in the File pull-down menu under Printer set up. It is possible to select the
ECM Print Service as specific printer; if the printer has been marked as
default printer in the Windows Settings, it will be already defined as default
printer in ChemStation.
To set the printer to ‘unattended mode’

Typically, when you print to an ECM Print Service, a dialog box asks you to
confirm the upload location in ECM as well as some other settings for each
report. If you are planning to print a whole sequence of reports, you can
confirm these settings once for the series and than run the printer in
unattended mode for a specified time. The duration of the unattended mode is
set in the Configuration of the ECM Print Service during setup, but can be
modified at any time.
1 Right-click the toolbar icon ECM Print Service and select Login Printer
Unattended.
Figure 36 Define Logon for Print Service
2 Select the printer that you want to operate in unattended mode.

3 Confirm the job settings once and click OK.

Configuring ECM Print Services - Adobe Distiller
1 Create a monitor folder on your ChemStation computer. The folder should

not be placed in the Chem32 directory.
2 Select the Add Printer icon to add a printer with the details:
• Type: Adobe Distiller
• Name: Specify a unique name, e.g. Chem1 Print
• Define the printer security options in accordance with your
organization’s security policies.
• In the upcoming Add Port dialog, choose Add Port and select the specified
monitor folder on the ChemStation computer.
3 Click Add to continue and browse for the monitor folder for the ECM print
service.
4 Open the printer configuration by marking your specific printer and select
the Configuration tab.
• ECM: you need to specify the ECM data path where the uploaded files will
be stored after transfer.
• Settings: Transfer specific settings.
• Hardcopy Printers: It is also possible to get a hardcopy printout.
• Email: It is possible to enable e-mail notification.
For details, refer to the ECM Print Services online help.

HINT
5 Click Apply to apply the configuration to the Print Service and leave the
dialog box with OK.
6 Depending on the Acrobat Distiller version in use, additional configuration
settings are necessary. A message requests you to perform certain tasks.
Example for Adobe Distiller Rev. 6.00:
In Start > Settings > Printers open the properties of the newly added printer.
Select Print Preferences.
• In the Adobe PDF Conversion Settings, deselect View Adobe PDF results.

• In the Adobe PDF Output Format, select the monitored path of the
• Select Edit for the default settings. On the upcoming Adobe PDF Settings
dialog, deselect optimize for fast Web View and save the settings.
7 Exit all printer-related dialog boxes with OK.
8 In ChemStation, it is now possible to specify the newly configured printer
in the File pull-down menu under Printer set up. It is possible to select the
ECM Print Service as specific printer; if the printer has been marked as
default printer in the Windows Settings, it will be already defined as default
printer in ChemStation.
To set the printer to ‘unattended mode’

Typically, when you print to a Print Service, a dialog box asks you to confirm
the upload location in ECM as well as some other settings for each report. If
you are planning to print a whole sequence of reports, you can confirm these
settings once for the series and than run the printer in unattended mode for a
specified time. The duration of the unattended mode is set in the
configuration of the ECM Print Service during setup, but can be modified at
any time.
1 Right-click the ECM Print Services toolbar icon and select Login Printer
Unattended, see Figure 36 on page 143.
2 Select the printer that you want to operate in unattended mode.
3 Confirm the job settings once and click OK.

Working with ECM Print Services in ChemStation
Working with ECM Print Services in ChemStation
When you use the ECM Print Service in ChemStation, any report printed using
the Print Services is converted to a *.pdf file, placed in the monitored folder,
and transferred by the print service to the specified location in ECM. During
conversion to PDF, the name supplied by the system is fixed. It is defined as
follows:
• single runs: [datafile name].pdf
• sequence runs: [sequence name]_ [datafile name].pdf
• sequence summary reports: SSR_[sequencename].pdf
The maximum file length for this automatically generated report name is 30
characters; longer files names are truncated. If, due to the truncation,
filenames are the same, the existing file is overwritten.
Be aware that when you specify the sequence pattern and datafile name in the sequence
NOTE setup, the complete *.pdf file name may not exceed 30 characters.

11
Troubleshooting
General Problems 148
ECM Server is not Available 148
Alerts and Error Messages at ChemStation Startup 149
Error Messages in the Spooler Queue Manager 150
The chapter gives some elementary troubleshooting hints.

11 Troubleshooting
General Problems
General Problems
ECM Server is not Available

If the ECM Server is not available while working with ChemStation, there are
two possible scenarios.
ECM Server is not available before/during login

If the ECM Server is not available while logging in to ECM from ChemStation,
the user cannot be authenticated by the ECM system. Login is aborted and
there will be no access to the ECM functions in ChemStation; all ECM-related
menu items will be grayed out.
For further troubleshooting, please contact your ECM administrator.
ECM Server is not available after login

If the ECM Server connection is interrupted after login to ECM from
ChemStation, the user has been authenticated by the ECM system. In this case,
ChemStation knows the current logged-in user.
When the ECM Server becomes unavailable, ChemStation automatically tries
to reestablish the user login.
The ECM Load and Save functions are accessible, but an alert informs the user
about the interrupted connection to the ECM.
While acquiring data, the automatic transfer of data to ECM cannot be
completed. The user is notified by an error message. and must manually
upload the data as soon as the connection is reestablished (ECM > Manage
Queue).
As soon as the ECM Server is available again, all ECM tasks are available
without restarting the application. A new login is not required.
For further troubleshooting, please contact your ECM administrator.

Troubleshooting 11
Alerts and Error Messages at ChemStation Startup
Alerts and Error Messages at ChemStation Startup
Your Transfer Settings/Remote Data Path seems to be set to default

At every startup, Agilent ChemStation checks whether all necessary
information is provided for transferring data to ECM. This message is shown if
the Remote Data Path is not set or is incomplete.
Probable cause Suggested actions
1 The Remote Data Path is not set or is Make sure that the information on ECM Server,
incomplete. ECM Account, and a complete LCDF path is
provided in the Transfer Settings (ECM >
Preferences > Transfer Settings).

11 Troubleshooting
Error Messages in the Spooler Queue Manager
Account Mismatch
1 Account setting in Preferences differs from Correct the Transfer Settings and connect to
current connection (or offline). ECM.
Host Mismatch
1 ECM Server in Preferences differs from Correct the Transfer Settings and connect to
current connection (or offline). ECM
The queue already contains items
1 There are items in the queue that have been Process queue in the correct order. If necessary,
queued before the current item. export items that can't be resolved.
Invalid license ID or license has expired.
1 Server license timeout. Log out and log in again.

Troubleshooting 11
You do not have permission to create a new Drawer/Folder.
1 You do not have appropriate privileges to Ask an administrator to give you the
create the Drawer or Folder. corresponding privileges or to create the needed
directories.
You do not have permission to add files.
1 You do not have appropriate privileges to Ask an administrator to give you the
save files to the specified location in ECM. corresponding privileges.
Unable to upload (filename). This file is currently checked out to

another user and may not be updated. (error -1).
1 Another user has checked out the file. The other user has to check in the file before
you can upload the file.

11 Troubleshooting

12
Appendix
ChemStation Privileges in ECM 154
ChemStation Roles in ECM 157
ECM related privileges concerning the ChemStation configuration 161

12 Appendix
ChemStation Privileges in ECM
Privilege Description
CS: Audit Trail Run: Enable the audit trail for a specific method
CS: Batch Run: Enables all operations in Batch view
CS: Break Session Lock Run: Unlock a ChemStation session locked by

other users
CS: Calibration Edit: Create and modify the calibration table;

change calibration settings
CS: Command Line Run: Turn on / off the command line
CS: Companion View: Access to Companion view (GC

ChemStation only)
CS: Control View: Access to Method and Run Control view
CS: Data Edit: Interactive saving of data to ECM

Delete: Delete data files in ChemStation
Explorer
CS: Data Analysis Run: Access to Data Analysis view
CS: Diagnostic View: Access to Diagnosis view
CS: Full Menu Run: Enable the ChemStation Full Menu

CS: Instrument Configuration Edit: Modify instrument configuration
parameters
CS: Instrument Setup Edit: Modify instrument method parameters
CS: Integration Events Edit: Modify Integration Events + perform Auto

Integration
CS: Ion Labels Edit: Edit options for Ion Labels (LC/MS-only)
CS: Logbook Edit: Save the current logbook

Delete: Clear the current logbook

Appendix 12
CS: Manage Transfer Queue Run: Access to the following items of the
Spooler Queue Manager
• Save selected item locally
• Delete selected item
• Properties
CS: Manual Integration Run: Perform manual integration
CS: Method Edit: Save method changes (includes Update

Sequence/Master Method in Data Analysis
view)
Delete: Delete a method in ChemStation
Explorer
CS: Method Properties Edit: Modify Run Time Checklist and Method
Information
CS: Print Report Run: Print/preview a report
CS: Recalibration Run: Perform interactive recalibration
CS: Report Edit: Modify report calculation/print style +edit

Instrument Curves dialog
CS: Report Layout View: Access to Report Layout view
CS: Report Template Edit: Save a report template

CS: Reprocess Run: Reprocess a sequence
CS: Retention Time Lock Edit: Access to the Retention Time Lock menu
(GC only)
CS: Retention Time Search Edit: Access to Retention Time Search menu
(GC only)
CS: Run Run: Start acquisition (single sample or

sequence)
CS: Sequence Edit: Save sequences

Delete: Delete sequences in ChemStation
Explorer
CS: Sequence Summary Edit: Modify sequence summary report and

extended statistics settings
CS: System Suitability Edit: Edit noise ranges and performance limits

12 Appendix
CS: Transfer Preference Edit: Edit the Transfer Settings in the

Preferences
CS: Tune View: Access to Tune view (LC-MSD

ChemStation only)
CS: Verification View: Access to Verification (OQ/PV) view

Appendix 12
ChemStation Roles in ECM
Please note: the default ChemStation roles do not contain any ECM privileges.
Table 3 Default CS Administrator privileges
Privilege View Edit Delete Add Run
CS: Audit Trail X
CS: Break Session Lock X
CS: Command Line X
CS: Control X
CS: Data X X
CS: Data Analysis X
CS: Diagnostic X
CS: Full Menu X
CS: Instrument Setup X
CS. Logbook X X
CS: Manage Transfer Queue X
CS: Manual Integration X
CS: Method X X
CS: Method Properties X
CS: Print Report X
CS: Report Layout X
CS: Report Template X
CS: Sequence X
CS: Transfer Preferences X

12 Appendix
Table 4 Default CS Analyst privileges
CS: Batch X
CS: Calibration X
CS: Control X
CS: Data X
CS: Data Analysis X
CS: Full Menu X
CS: Integration Events X
CS. Logbook X
CS: Method X X
CS: Print Report X
CS: Recalibration X
CS: Report X
CS: Report Layout X
CS: Reprocess X
CS: Run X
CS: Sequence X X
CS: Sequence Summary X
CS: System Suitability X

Appendix 12
Table 5 Default CS Lab Manager privileges
CS: Audit Trail X
CS: Batch X
CS: Break Session Lock X
CS: Calibration X
CS: Command Line X
CS: Companion X
CS: Control X
CS: Data X X
CS: Data Analysis X
CS: Diagnostic X
CS: Full Menu X
CS: Instrument Configuration X
CS: Integration Events X
CS. Logbook X X
CS: Manage Transfer Queue X
CS: Method X X
CS: Print Report X
CS: Report X
CS: Report Layout X
CS: Reprocess X
CS: Run X

12 Appendix
Table 5 Default CS Lab Manager privileges
CS: Sequence X X
CS: System Suitability X
CS: Transfer Preferences X
CS: Tune X
CS: Verification X
Table 6 Default CS Operator privileges
CS: Control X
CS: Data X
CS: Print Report X
CS: Run X
CS: Sequence X

Appendix 12
ECM related privileges concerning the ChemStation configuration
ECM related privileges concerning the ChemStation

configuration
The privileges described in the following table must be assigned to at least one
of your roles in order to become active.
Table 7 List of ECM related privileges
Privilege View Edit Delete Add Run Description
Content: File X X • Minimum privilege for ChemStation

to access ECM
• Privileges to view ECM Properties in
ChemStation
Content: File Filtering X • Minimum privilege for ChemStation

to access ECM
• Privilege to add files manually to an
ECM folder
Content: File Revisions X • Privilege to view revisions in

ChemStation
Content: File Type [XLS] X X • Privilege to add and check in files

with an .xls extension
Content: Folder X X X • Minimum privilege for ChemStation

to access ECM
• Privilege to view ECM Properties in
ChemStation
Content: Folder Access X • Privilege to view and change any

Properties folder property tab
Content: Rekey File X • Privilege to rekey files in ECM e.g.

with XML Filters
System: Advanced Search X • Privilege to use the Advanced

Search in ChemStation
System: Audit Trail X • Privilege to view ECM Properties in

ChemStation

12 Appendix
ECM related privileges concerning the ChemStation configuration
Table 7 List of ECM related privileges
Privilege View Edit Delete Add Run Description
System: Filtering X • Privilege to view or change the

Configuration filtering configuration
• Privilege to use attribute extraction
services and to manage
user-defined attributes
System: indexing X • Minimum privilege for ChemStation

Configuration to access ECM
• Privilege to view ECM Properties in
ChemStation
System: Quick Search X • Privilege to use Quick Search in

ChemStation
System: Super Object X • Privilege is mandatory for OLIR
System: Project X • Privilege to view projects in OLIR
System: Project Access X • Privilege to access projects in OLIR

Index
Index
2 checkout status 69, 77 ECM web client 11

ChemStation administration tool 32 ECM web client 16, 29
21 CFR Part 11 17, 84
ChemStation administration tool 34, 97 ECM account 25, 48
A ChemStation operator 41 ECM audit trail 90
ChemStation filter 132 ECM database 23
ACAML filter 135
ChemStore 21 ECM menu 44
ACAML 120
cleanup data 45, 52 ECM server 48
access 40
closed system 85 ECM unavailable
account configuration 93
configuration steps for part 11 87 start ChemStation 98
account 25, 41, 93
consecutive signature timeout 101 ECM versions 20
activity log 91, 92
Contributor role 96 ECM 10
Add File dialog 75, 80
Contributor role 27 electronic signature 17, 84, 100
Add Folder privilege 27
Create OpenLAB Intelligence Report 121 error messages 149
administration tool 32
Create OpenLAB IR Report 129
administration tool 34, 97 F
CSAdministrators 35
AES 131, 132
custom fields reporting 110 file format 59
after acquisition 64, 66
custom fields values 108 filter keys 132
after any data modification 66, 71
custom fields 104 filter
after any data modification 51
ACAML 135
after reprocessing 71
D folder 16, 50, 96
after acquisition 50
data file logbook 89
after reprocessing 51
default printer 145 G
attribute extraction service 131, 132
diagnosis view 44 group 35, 94
audit trail 17, 88
domain 41
authentication 40
drawer 16, 50 I
available in folder access tab 96
import after reprocessing 51, 72
B E inactivity timeout 94
Easy Access 21 installation
break session lock 98
ECM Desktop Open dialog 69, 77 on ChemStation computer 28
ECM forced upload 66 on ECM server 23
C
ECM print services 140
cabinet 16, 50 K
ECM system log 92
calculate peak performance 51
ECM user 41 keys 132
checked out 69, 77, 79

Index
L preferences 47 server software 20

prerequisites server URL 41
LCDF 16, 27, 48
OpenLAB IR 122 session lock 41, 99
license key 31
OpenLAB Option 20 signature screen timeout 101
load data 68
print management system 140 software certificate 31
load method 77
print services 140 spooler queue manager 53
location 16, 50
privately locked 42 SQLCmd 24
lockout 41, 94
privilege 26, 27, 100 SQLPlus 23
logbook 88
Purify 21 SQLServer 24
login 32, 40, 98
ssizip 59, 62
Q Start OpenLAB IR 129
M
quick search 132 system administrator email 94
manage queue 45, 52
system log 92
mandatory login 32, 98
R
menu items grayed out 148
Reader role 27 T
metadata 131
registration packet 31 time based lock 42
method audit trail 88
registration 31 time based lock 99
Microsoft .NET Framework 30
remote data path 16, 48 timeout 94, 101
minimum password length 94
remote data path 47 token 49
monitor folder 142
report template 128 transfer settings 47, 50
N report examples 123
report history 90 U
non privately locked 42
report.txt 137 unattended mode 143, 145
reporter client 128 unauthorized access 40
O
report 127 uninstallation 37
open system 85 reporting 110 update methods 45
OpenLAB Intelligence Reporter 120 require entry in reason field 94 update sequences 45
OpenLAB Option 11 result.xml 136 URL 41
operator 41 results audit trail 89 user interface
OQ/PV view 44 role 25, 26, 27, 94, 96 OpenLAB IR 128
Oracle 23 run.log 89 OpenLAB Option 43
user name 41
P S user preferences 102
Part 11 17, 84 save method 79 user 26, 41, 94
password 41, 95 search expression 133
path 16, 47, 49 search types 132 W
PDF format 139 sequence container 59 web client 11, 16
PDF-XChange 30 server not available 148 web client 29

Index
workflows
data related 63
data related 12
methods/sequence templates 14,
74
OpenLAB IR 122

www.agilent.com
In This Book
This guide contains installation and reference

information for the ECM Interface between
Agilent ChemStation and an Agilent Enterprise
Content Manager (ECM) client/server system.
© Agilent Technologies 2008-2009, 2010

Printed in Germany
09/2010
*G2170-90037*
*G2170-90037*
G2170-90037
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Agilent ChemStation

ChemStation OpenLAB Option Concepts Guide

In This Guide ...

This guide contains installation and reference information for ChemStation

3 Basic Concepts of ChemStation OpenLAB Option

4 Working With ChemStation OpenLAB Option

5 Administration Regarding 21 CFR Part 11 Compliance

ChemStation OpenLAB Option Concepts Guide 3

7 Treatment of ChemStation Legacy Data and Data Migrated from ChemStore

8 Interface to OpenLab Intelligence Reporter

9 Attribute Extraction Services for ChemStation Data

10 Using Print Services in ChemStation

4 ChemStation OpenLAB Option Concepts Guide

3 Basic Concepts of ChemStation OpenLAB Option 39

4 Working With ChemStation OpenLAB Option 61

5 Administration Regarding 21 CFR Part 11 Compliance 83

ChemStation OpenLAB Option Concepts Guide 5

6 Custom Fields 103

7 Treatment of ChemStation Legacy Data and Data Migrated from

8 Interface to OpenLab Intelligence Reporter 119

9 Attribute Extraction Services for ChemStation Data 131

10 Using Print Services in ChemStation 139

6 ChemStation OpenLAB Option Concepts Guide

ChemStation OpenLAB Option Concepts Guide 7

8 ChemStation OpenLAB Option Concepts Guide

This chapter introduces ECM, the implementation of OpenLAB Option in

The Agilent Enterprise Content Manager (ECM) is a web-based electronic

10 ChemStation OpenLAB Option Concepts Guide

Add-On Solution for ChemStation: OpenLAB Option

Starting with revision B.02.01 SR1, Agilent ChemStation provides an interface

ChemStation OpenLAB Option Concepts Guide 11

Overview of data-related workflows

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Workflow 1: Raw data acquisition and automatic transfer to ECM

12 ChemStation OpenLAB Option Concepts Guide

Workflow 2: Offline revision during acquisition

Workflow 3: Reprocessing data and automatic upload to ECM

Workflow 4: Import after reprocessing

ChemStation OpenLAB Option Concepts Guide 13

Overview of workflows for methods/sequence templates

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Workflow 1: Uploading a new method

14 ChemStation OpenLAB Option Concepts Guide

Workflow 2: Saving a changed method

ChemStation OpenLAB Option Concepts Guide 15

Data Storage in ECM

Figure 1 LCDF structure in ECM

16 ChemStation OpenLAB Option Concepts Guide

21 CFR Part 11 Compliance

ChemStation OpenLAB Option Concepts Guide 17

18 ChemStation OpenLAB Option Concepts Guide

This chapter describes the installation and configuration of ChemStation

20 ChemStation OpenLAB Option Concepts Guide

ChemStation OpenLAB Option Concepts Guide 21

Support for Windows 7 with OpenLAB Option

22 ChemStation OpenLAB Option Concepts Guide

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