UV IQP ZEMA-0004B Rev310

ZEMA-0004B
Document No.
SHIMADZU UV-VIS SPECTROPHOTOMETER

UV-1700 / 1800 / 1650PC / 2450 / 2550 / 3600series
Installation Qualification
Installation Qualification Protocol
We here by confirm that all contents (including changes) of the verification inspection described in this document have
been approved in the presence of the performer, reviewer and the manager.
· Performer Signature Date
Print / /
Title
Certificate No.
(Shimadzu-certified Performer only)
Company
· Reviewer Signature Date
Print / /
Title
Company
· Manager Signature Date
Print / /
Title
Company
Installation Qualification Table of Contents
Table of Contents
1. DEFINITIONS ..........................................................................................................................................4
1-1 Documentation ................................................................................................................................4
1-2 Scope...............................................................................................................................................5
1-3 Entries and Revisions ......................................................................................................................6
2. PRELIMINARY CHECKS ......................................................................................................................7
2-1 Reviewer Confirmation ...................................................................................................................7
2-2 Performer Identification & Approval ..............................................................................................7
2.3 Product Specifications ....................................................................................................................7
3. PRE-INSTALLATION QUALIFICATION ...........................................................................................8
3-1 Equipment List ................................................................................................................................8
3-2 Instruction Manuals ........................................................................................................................8
3-3 Certificates ......................................................................................................................................8
3-3-1 Certificate of Compliance and Inspection Result Sheet ...........................................................8
3-3-2 Software Development and its Validation ................................................................................9
3-4 Installation Environment ...............................................................................................................10
3-4-1 Installation Environment........................................................................................................10
3-4-2 Power Supply .........................................................................................................................10
3-5 Equipment Information ................................................................................................................. 11
3-5-1 UV-VIS Spectrophotometer ................................................................................................... 11
3-5-2 UVProve Spectrophotometer Control Software .................................................................... 11
3-5-3 Computer and Peripherals ......................................................................................................12
3-5-4 Syringe Sipper N/CN .............................................................................................................12
3-5-5 Auto Sample Changer ASC-5 ................................................................................................12
3-5-6 Elution Test 6-Cell Holder DIS-1200 ....................................................................................12
3-5-7 Elution Test 8-Cell Holder DIS-8 ..........................................................................................13
3-5-8 Cell Positioner CPS-240A/B .................................................................................................13
3-5-9 Thermoelectrically Temperature Controlled Cell Holder TCC-240A....................................13
3-5-10 Screen Copy Printer ...............................................................................................................14
3-5-11 ESC/P Compatible Screen Copy Printer ................................................................................14
3-5-12 PCL Compatible Printer .........................................................................................................14
3-5-12 Time Course (Multi λ) Program Pack ....................................................................................14
3-5-13 DNA/Protein Quantitation Program Pack ..............................................................................14
3-5-14 Protein Quantitation Program Pack .......................................................................................14
3-5-15 CLASS-Agent Software ........................................................................................................14
3-5-16 Validation Software Package .................................................................................................15
3-5-17 Color Measurement Software COL-UVPC ...........................................................................15
3-5-18 Film Thickness Measurement Software FLM-UVPC ............................................................15
4. INSTALLATION QUALIFICATION ...................................................................................................16
4-1 Personal Computer and Peripherals ..............................................................................................16
4-1-1 Personal Computer Setup.......................................................................................................16
4-1-2 Computer Date and Time .......................................................................................................17
4-2 UVProbe Spectrophotometer Control Software............................................................................18
4-2-1 Appearance and Installation Check .......................................................................................18
4-2-2 Installation Mode Check ........................................................................................................18
4-2-3 Alteration Check ....................................................................................................................18
4-2-4 Security Settings Check .........................................................................................................18
4-3 UV-VIS Spectrophotometer UV-1700 ..........................................................................................19
4-4 UV-VIS Spectrophotometer UV-1800 ..........................................................................................19
4-5 UV-VIS Spectrophotometer UV-1600PC/UV-1650PC .................................................................19
4-6 UV-VIS Spectrophotometer UV-2401PC/UV-2450 ......................................................................19
4-7 UV-VIS Spectrophotometer UV-2501PC/UV-2550 ......................................................................20
4-8 UV-VIS-NIR Spectrophotometer UV-3600 ..................................................................................20
4-9 Syringe Sipper N/CN ....................................................................................................................20
4-10 Auto Sample Changer ASC-5 .......................................................................................................20
Page 2 of 29 Rev 3.10

4-11 DIS-1200 Elution Test 6-Cell Holder............................................................................................20
4-12 DIS-8 Elution Test 6-Cell Holder .................................................................................................21
4-13 Cell Positioner CPS-240 A/B ........................................................................................................21
4-14 Thermoelectrically Temperature Controlled Cell Holder TCC-240A ...........................................21
4-15 HCP-1C Screen Copy Printer .......................................................................................................21
4-16 DPU-414 Screen Copy Printer ......................................................................................................21
4-17 MPU Screen Copy Printer ............................................................................................................21
4-18 ESC/P Compatible Screen Copy Printer .......................................................................................21
4-19 PCL Compatible Screen Copy Printer ..........................................................................................21
4-20 Time Course (Multi λ) Program Pack ...........................................................................................22
4-21 DNA/Protein Quantitation Program Pack .....................................................................................22
4-22 Protein Quantitation Program Pack...............................................................................................22
4-23 Class-Agent Software ...................................................................................................................23
4-23-2 Installation Mode Check ........................................................................................................23
4-24 Validation Software Package ........................................................................................................24
4-25 Color Measurement Software COL-UVPC ..................................................................................24
4-26 Film Thickness Measurement Software FLM-UVPC ...................................................................25
5. EQUIPMENT MANAGEMENT ...........................................................................................................26
5-1 Control of Changes .......................................................................................................................26
5-2 Maintenance ..................................................................................................................................26
5-3 Spare Parts ....................................................................................................................................26
6. CHANGE LIST .......................................................................................................................................27
Rev 3.10 Page 3 of 29

Installation Qualification Definitions
1. Definitions
1-1 Documentation
1. The purpose of this document is to collect, confirm and record the results of the Installation Qualification of the
Shimadzu UV-VIS spectrophotometers.
This document checks the installation site/environment, confirms equipment specifications, checks
documentation such as instruction manuals, and verifies the condition of the installed equipment.
2. The following are established as the responsible parties in the execution of inspections.
· Performer
The Performer is the individual who actually performs the procedures stipulated in the Installation
Qualification Protocol and the Operational Qualification Protocol. The Performer also verifies the validity of
the procedures.
The Performer shall either be an individual who, having been trained by the Quality Assurance Department
of the Analytical & Measuring Instruments Division of Shimadzu Corporation, has been certified as an
IQ/OQ inspector by the relevant manager (General Manager of the Quality Assurance Department), or an
individual recognized by the Manager to be equipped with the ability to conduct this inspection.
· Reviewer
The Reviewer is an individual designated by the Manager charged with responsibility for the system.
The Reviewer verifies the contents of the Installation Qualification Protocol and Operational Qualification
Protocol documentation. In addition, the Reviewer shall attend the inspection procedures together with the
Performer, and evaluate the procedures.
The Manager can serve concurrently as the Reviewer.
· Manager
The Manager is the individual responsible for administering the entire UV-VIS system being inspected. As
well as verifying the contents of the Installation Qualification Protocol and Operational Qualification
Protocol documentation, the Manager shall also grant final approval to the inspection procedures.
3. The Performer shall first check the content of this entire document. After checking all items, the Performer
shall sign and date the cover sheet of this document and submit this document as an installation qualification
protocol. (IQ must be performed by a trained and knowledgeable individual in accordance with 21 CFR Part
211 Section 211.25 (cGMP, USA promulgated 29 September 1978)).
4. The Reviewer shall first check the content of this entire document. After checking all items, the Reviewer shall
sign and date the cover sheet of this document as approval of the Installation Qualification Protocol.
5. The Manager shall first check the content of this entire document. After checking all items, the Manager shall
enter a unique document control No. in the Document No. space at the top right of the cover sheet, and then
sign and date the cover sheet of this document as final approval of the Installation Qualification Protocol.
6. This document is comprised of 1. Definitions, 2. Preliminary Checks, 3. Pre-installation Qualification, 4.

Installation Qualification, 5. Equipment Management and 6. Change List. All of these sections must be
included.
7. This document contains important information and any form of duplication, photography, or reproduction
without the permission of the General Manager of the Quality Assurance Department, Analytical & Measuring
Instruments Division, Shimadzu Corporation, is prohibited. However, the records of the inspections conducted
using this document may be duplicated at the discretion of the Manager.

1-2 Scope
(Scope of Installation Qualification)
The Installation Qualification Protocol shall include the following.
· Pre-installation Qualification
Confirmation of the specifications of the analytical equipment.
Confirmation and maintenance of documents (instruction manuals, Qualification Protocol and certificates).
Confirmation of installation site and conditions.
Confirmation of the delivered equipment.
· Installation Qualification
Connection, confirmation, and installation qualification of each unit shall be executed by verifying that each
unit is connected correctly.
· Confirmation of Software and Firmware

The scope of the Installation Qualification extends to the verification of software and firmware. Verify that the
versions stated in the certificates etc. provided with the equipment is consistent with the actual versions
displayed when the power is turned on. Verifications with the power turned on shall be executed in
accordance with the OQ (Operational Qualification) Protocol.
During installation, the software and firmware may be upgraded to versions regarded appropriate by
Shimadzu Corporation. In this case, enter the new version in the version information entry column in “4.
Installation Qualification”, and clearly state a comment to this effect in the margin.

1-3 Entries and Revisions

1. Making entries
Use a permanent ballpoint pen, or equivalent, when recording results.
Names should be clearly printed.
Confirm that all items, except “Remarks” columns, are completed, and that there are no omissions.
Draw a diagonal line (from bottom left to top right) across all blank columns. (When making no entries, it is
not necessary to enter the “Change List No.__”, “Date” or “Signature”, or to enter the reason for the change in
the Change List of this document.)
Columns in which nothing has to be written in has been filled in with “N/A” in advance.
If choices are available within an item, place a checkmark in the box to select the appropriate decision.
2. Deletion and correction of mistakenly filled items

To correct mistaken entries such as inspection results, delete the entire entry by drawing a diagonal line
through it and enter the correction in the margins. To correct numerical values or symbols (checkmarks), draw
2 horizontal lines across the mistake and re-write the entry. Moreover, write the date, and the signature, and the
reason for the change. (When deletion and correction of mistakenly filled items, it is not necessary to enter the
“Change List No.__”, “Date” or “Signature”, or to enter the reason for the change in the Change List of this
document.)
3. Changing or deleting steps, procedures or acceptance criteria

If there are parts of the steps or procedures which will not be applied, draw a diagonal line through the entire
item and write “Change List No. __” above the line and assign a number to it. Date and sign it. Enter the
necessary information in the Change List of this document.
When making a change, delete the existing description as explained above, enter the change point, and then
write down the reason for the change in the Change List.
4. Revising entries
If the need to alter the contents of an entry arises, change the entry in accordance with “2. Deletion and
correction of mistakenly filled items”, and then write the reason for the change in the Change List of this
document.
When adding a new description, write it in the margins of the relevant page, and write “Change List No. _”, the
date and signature. Then, write the reason for the change in the Change List.
5. Handling Problems
Any problems identified in Installation Qualification must be investigated and appropriate actions must be
taken. All such actions must be documented and be approved by the Manager.
6. In the event of a Fail

If troubles occur during an inspection and the item fails the inspection, place a checkmark in the “Fail” box and
describe the problem in the margins of the relevant page. Write “Change List No. _” and date and sign the entry.
Enter an outline of the problem in the Change List.
After the problem is solved, describe the solution and the result (“Pass”) in the margins of the relevant page.
Write “Change List No.__” and date and sign the entry. Enter the summary of the solution in the Change List
of this document.
7. Attaching data
Attached data are added by assigning page numbers as “A, B, C…” for each inspection item. If, for example,
there is a total of 3 sheets for attachment A, notate the pages as “32-A-1/3 - A-3/3”, ensuring that no numbers
are omitted. The Performer shall date and sign the attached data.
8. Other
Every item entered into the Change List shall be approved by the Reviewer and Manager.

Installation Qualification Preliminary Checks
2. Preliminary Checks
2-1 Reviewer Confirmation

Before conducting this inspection, the Manager shall designate the Reviewer. Record the Reviewer information
in the report. The Manager may also double as the Reviewer.
2-2 Performer Identification & Approval

The performer must be an individual who is trained and has adequate knowledge of this installation
qualification procedure. The Quality Assurance Department of the Analytical & Measuring Instruments
Division of Shimadzu Corporation performs such education, and recognizes individuals who are qualified to
perform the IQ/OQ procedures. An individual who is recognized as having been trained and who possesses
sufficient knowledge is certified by the General Manager of the Quality Assurance Department as a qualified
IQ/OQ Inspector, as proven by the certificate. A person who is recognized as having the ability to perform this
inspection may also perform this installation qualification procedure.
Before performing this installation qualification, the Performer’s qualification shall be confirmed and recorded
in the report.
2.3 Product Specifications

Verify the product specifications of each unit, and check that the delivered products satisfy the specification
requirements for the purpose intended.
Rev 3. 10 Page 7 of 29
Installation Qualification Pre-installation Qualification
3. Pre-installation Qualification
3-1 Equipment List

The units and items comprising this system are to be recorded in the following equipment list. Place check marks
in the “Applicable” check box for the units comprising this system, and also enter the Serial No. for each unit.
If the unit is not included in the system, place a check mark in the “Not Applicable” box.
3-2 Instruction Manuals

For the units included in the system to be inspected, place a checkmark in the “Applicable” box and verify that
the instruction manual is supplied. If the instruction manual is supplied, place a checkmark in the “Checked”
column and record its storage site. If the unit is not included in the system, place a checkmark in the “Not
Applicable” box.
Place a checkmark by the letter, A - C and enter the details of the storage site in the Storage Site Table to
designate the site where the instruction manuals are stored. Choose a letter (A, B, or C) that represents the
storage site of each manual and enter it into the “Storage Site” column in the table below.
3-3 Certificates
3-3-1 Certificate of Compliance and Inspection Result Sheet
Shimadzu Corporation provides the following certificates for each unit. Check that they are provided with the
equipment.
· Certificate of Compliance
· Inspection Report (Spectrophometer unit only)
The Certificate of Compliance certifies that the delivered equipment was inspected at the time of production and
shipping based on predetermined procedures; that it passed the inspections, and that it meets the prescribed
specifications.
When strict control is required for the instrument (e.g., GLP/GMP compliance is required), the Certificate of
Compliance can be used as a document that proves the conformance of the equipment at the time of shipping
from the manufacturer. The submission of the Certificate of Compliance may be required during audits by public
organizations such as the U.S. FDA (Food and Drug Administration).
The Inspection Report shows the results of the final inspection at the time of shipping from the factory.
Page 8 of 29 Rev 3. 10
3-3-2 Software Development and its Validation
Development and quality assurance of the software provided by Shimadzu Corporation are performed as
described below.
Overview
Shimadzu's Software Development Group always uses the latest technology in order that software products are
developed in a controlled and traceable environment. This fulfills the requirements of the Japanese Ministry of
Health, Labour and Welfare and the U.S. FDA.
Development Process
The development procedure follows the waterfall model. That is to say, the development procedure is
comprised of a process to ascertain the functions required by the user (external design), a process to design the
required functions and the program functions (internal design), a program structure design process (program
design), programming process, test process, and maintenance process. Engineers are assigned to each project
according to the development content, period of the development cycle, and its development priority. Project
engineers are not only equipped with software expertise, but have also received training regarding relevant laws
and regulations.
Quality Control
Shimadzu Corporation tests all firmware and software with stringent functional testing and validation during
code development according to our internal quality control system.
Document Control
Documents pertaining to the development of software are recorded and controlled. If the records need to be
presented during audits by public organizations such as the Japanese Ministry of Health, Labour and Welfare
and the U.S. FDA, the documents may be presented to a neutral third party upon the conclusion of a
non-disclosure agreement.
Management of Design Changes

All changes to software are documented for design consistency and code management.

3-4 Installation Environment

The environmental conditions specified below shall be satisfied for the equipment to operate normally.
3-4-1 Installation Environment

(Temperature) Temperature during operation must be within the 15 to 35ºC range with small daily
temperature fluctuations.
(Humidity) Humidity during operation must be within 20 to 80%.

(Above 30ºC, however, humidity must be 70% or less.)
(Bench)
· Space Requirements: Listed in section 3-5 for each component
· Strength Requirements: Listed in section 3-5 for each component
(Other) Avoid exposure to air from air-conditioners.

Avoid exposure to direct sunlight.
Avoid exposure to vibrations.
Clean location, free of dust and corrosive gases.
Avoid exposure to instruments that can generate strong magnetic fields.
3-4-2 Power Supply

(Voltage) 100V – 120V±10%, 220V – 240V±10%
(Frequency) 50/60 Hz
(Connection) The instrument must be grounded.

If the outlet used is the two-prong type, use a power adapter with a grounding lead wire
connected to the grounding terminal. If the outlet used is not equipped with a grounding
terminal, the equipment must be connected to an earth-grounded object. If the outlet used is the
three-prong type, the connection above is not required.
(However, this excludes items that do not require to be grounded, even if the outlet is the
2-prong type.)

3-5 Equipment Information

Check the equipment information for each unit. Check that all of the accessories listed in the instruction manual
for each unit are provided, and select the allocation connection addresses at the pump units and detectors. In
addition, for each unit that will be managed, enter the management ID for the Component ID column. If only
the system is to be managed, the component IDs need not be entered.
In addition, from the information below, check the size of each unit, power consumption, etc., and place a
check in the checked check box.
As for the Workstation, enter the necessary information for the PC and peripheral devices, as well as the
installed software (UVProbe).
3-5-1 UV-VIS Spectrophotometer
Power Power
Model Size (mm) Weight Frequency
Consumption
Supply
UV-1700 130 VA
W550 ×D470 ×H200 (mm) AC 100 - 120 V
UV-1601PC 17 kg 50/ 60 Hz
(*W700 ×D500 ×H450) AC 220 - 240 V 160VA
UV-1650PC
* The specification requirements for installation space include 10 cm for ventilation in the back of the unit, the space for
cable connections on the sides and the space required for opening and closing the sample compartment lid.
Power Power
Consumption
Supply
W450 ×D490 ×H270 (mm) AC 100 - 120 V
UV-1800 15 kg 50/ 60 Hz 140 VA
(*W600 ×D600 ×H550) AC 220 - 240V
Power Power
Consumption
Supply
UV-2401PC
UV-2450 W570 ×D660 ×H275 (mm) AC 100 - 120 V
36 kg 50/ 60 Hz 190 VA
UV-2501PC (*W800 ×D760 ×H500) AC 220 - 240V
UV-2550
Power Power
Consumption
Supply
W1020 ×D660 ×H270 (mm) AC 100 - 120 V
UV-3600 96 kg 50/ 60 Hz 300 VA
(*W1300 ×D800 ×H500) AC 220 - 240V
3-5-2 UVProve Spectrophotometer Control Software

Model Supported Models
UV-1700*1)/1800*2)/1601PC/1650PC
UVProbe
/2401PC/2450/2501PC/2550/3600
*1 Control of the UV-1700 requires that a PC and peripheral devices, and a communication cable (RS-232C cable) be
obtained separately.
*2 Control of the UV-1800 requires that a PC and peripheral devices, and a USB communication cable be obtained
separately.

3-5-3 Computer and Peripherals
The personal computer and peripheral devices are used to control the spectrophotometer via an RS-232C port,
and acquire, display and print data. The personal computer that is used to run UVProbe and other optional
software must comply with the following specifications.
CPU Intel Pentium II processor CPU 400MHz or greater
RAM 256 MB minimum
HDD 3.2GB minimum
Mouse PS/ mouse
Interface Serial port (RS-232C: D-SUB (male) 9-pin)
CRT SVGA (800 × 600, 256 colors) minimum
Printer Printer compatible with the Windows version
(It is recommended to use a printer with operation guaranteed.)
Software Driver for the printer
OS The following software packages have been verified to run using the indicated
operating systems (OS).
Microsoft Windows 2000 Professional / XP Professional
The software versions that are supported are as follows.

· UVProbe Ver.2.00 or higher
· CLASS-Agent Ver.2.20 or higher
· Validation Software Ver.3.00 or higher
· UVPC-COL Ver.3.00 or higher
· UVPC-FLM Ver.3.00v
3-5-4 Syringe Sipper N/CN

Power Power
Consumption
Supply
Syringe Sipper N 3.4 kg
*W 95×D 145×H 300 (mm) N/A N/A N/A
Syringe Sipper CN 3.7 kg
* The cell section of the Syringe Sipper N/CN attaches to the spectrophotometer sample compartment, so the syringe
pump dimensions are given as the required space for installation. However, keep in mind that space is also necessary
for routing the cable that connects the pump section with the main unit.
3-5-5 Auto Sample Changer ASC-5

Power Power
Consumption
Supply
W410 ×D490 ×H495 (mm)
ASC-5 19.5 kg AC 100 V 50/ 60 Hz 65.2 VA
(*W510 ×D590 ×H495)
* Installation space requirements include space for cables.
3-5-6 Elution Test 6-Cell Holder DIS-1200

Power Power
Consumption
Supply
N/A
DIS-1200 (Installed inside main unit sample 3 kg N/A N/A N/A
compartment)

3-5-7 Elution Test 8-Cell Holder DIS-8
Power Power
Consumption
Supply
N/A
DIS-8 (Installed inside main unit sample 3.3 kg N/A N/A N/A
compartment)
3-5-8 Cell Positioner CPS-240A/B

Power Power
Consumption
Supply
CPS-240A Controller unit:
W160 ×D420 ×H140 (mm)
(*1 W260 ×D520 ×H140)
*3
12.5 kg AC V Hz 90 VA
CPS-240B Sample compartment unit:
W120 ×D470 ×H155 (mm)
(*2 W120 ×D260)
*1 Installation space requirements include space for cables.

*2 This is the size of the portion projecting from the sample compartment. The cell section of the CPS-240A/B attaches
to the spectrophotometer sample compartment. However, the actuation control section projects forward from the
front of the equipment. Therefore it is necessary to consider work efficiency when deciding the installation location.
*3 The controller weighs 7kg, and the cell holder 5.5kg.
3-5-9 Thermoelectrically Temperature Controlled Cell Holder TCC-240A

Power
Power
Model Size (mm) Weight Frequency Consumpti
Supply on
Controller unit:
W160 ×D420 ×H140 (mm)
(*1 W260 ×D520 ×H140)
*3
TCC-240A 9.5 kg AC V Hz 80 VA
Sample compartment unit:
W130 ×D340 ×H130 (mm)
(*2 W100 ×D120)
*1 Installation space requirements include space for cables.

*2 This is the size of the portion projecting from the sample compartment. The cell section of the TCC-240A attaches to
the spectrophotometer sample compartment. However, the actuation control section projects forward from the front
of the equipment. Therefore it is necessary to consider work efficiency when deciding the installation location.
*3 The controller weighs 7kg, and the cell holder 2.5kg.

3-5-10 Screen Copy Printer
Power Power
Consumption
Supply
W190 ×D250 ×H110 (mm) *2
80 VA
HCP-1C 2.2 kg
(*1 W290 ×D350 ×H110) (*315VA)
W160 ×D170 ×H66.5 (mm) *2
DPU-414 0.58 kg AC V Hz 30 VA
(*1 W160 ×D220 ×H70)
W168 ×D155 ×H87 (mm) *2
MPU 0.82 kg 40 VA
(*1 W220 ×D160)
*1 The installation space requirement specification includes the space for connecting cables.
*2 The weight of the recording paper and battery are not included.
*3 Indicates the standby power consumption.
3-5-11 ESC/P Compatible Screen Copy Printer

The ESC/P compatible printer is a commercially available printer, and by connecting it to the UV-1700/1800
using a parallel printer cable, it enables printing out hard copies of the screen, etc. In order to print out screen
copies, the printer control mode must support ESC/P*1 printer commands.
*1 The UV-1600/1700 is equipped with a parallel port. The UV-1800 is equipped with a USB interface, and uses a
USB cable.
*2 Depending on the printer, ESC/P-J84 or ESC/P Super are denoted. Printers specified only as ESC/P Raster or
ESC/Page cannot be used with the UV-1600 and 1700. ESC/P Raster printers can be used with the UV-1800.
3-5-12 PCL Compatible Printer

The PCL compatible printer is commercially available, and by connecting it to the UV-1800 using USB cable, it enables
printing out hard copies of the screen, etc. In order to print out screen copies, the printer control mode must support PCL
printer commands.
3-5-13 Time Course (Multi λ) Program Pack

Model Supported Model
N/A UV-1700
3-5-14 DNA/Protein Quantitation Program Pack

N/A UV-1700
3-5-15 Protein Quantitation Program Pack

N/A UV-1700
3-5-16 CLASS-Agent Software

CLASS-Agent UVProbe

3-5-17 Validation Software Package

UV-1601PC/1650PC/2401PC/2450
N/A
/2501PC/2550
3-5-18 Color Measurement Software COL-UVPC

1)
UV-1700* /1601PC/1650PC/2401PC/2450
COL-UVPC
/2501PC/2550/3600
3-5-19 Film Thickness Measurement Software FLM-UVPC

1)
UV-1700* /1601PC/1650PC/2401PC/2450
FLM-UVPC
/2501PC/2550/3600

Installation Qualification Installation Qualification
4. Installation Qualification
This section verifies that the equipment has been installed correctly.
Place a checkmark in the “Applicable” box for the units included in the system to be inspected.
4-1 Personal Computer and Peripherals

4-1-1 Personal Computer Setup
Check that the personal computer setup, including the computer settings and installed programs, matches the
relevant specifications.
4-1-1-1 Checking Computer Appearance, Connection, and Installed Software

1. Appearance Check
Check the external appearance of the PC for scratches, dirt, and other abnormalities.
2. Wiring Check
Install the computer and peripherals, connect the wiring and power supply in accordance with the
instruction manuals. Connect the spectrophotometer as described in the “Connecting an External
Computer” section of the spectrophotometer instruction manual (Operation Manual).
3. Version Check
Confirm the operating system (OS) version by following the procedures below. Also install the printer
driver and confirm its version.
1) Checking the Operating System Version

From the Windows [Start] menu, choose [Settings] and [Control Panel] to open the control panel and
select [System]. Confirm and note the version from the system information included under the [General]
tab.
2) Checking the Printer Driver Version

Install the printer driver that comes with the printer and confirm that it has been installed properly. From
Window’s [Start] menu, choose [Settings], then [Printer]. Select the printer that will be used from the list
shown in the printer dialog box and right-click it to choose [Properties] for that printer. From the
[General] tab, execute [Print Test Page]. Confirm and enter the driver version from that information.
3) Other Software Checks

Enter the names of any the other installed software, place a check mark in the check box in front of the
software name, and enter the version number. For details on the method for checking the software version,
refer to the respective software instruction manual.
Note) This is not required for software included as standard with Windows, such as Internet Explorer, etc.
4. Hard Drive File System Check

From the Windows desktop double-click and open “My Computer”. Right-click each drive on the hard disk
and select [Properties] from the menu. The [General] tab display will indicate FAT, FAT32 or NTFS for the
file system. Check that it matches the specification requirements. If the specifications do not specify a
requirement, simply note the file system.
Page 16 of 29 Rev 3. 10
4-1-1-2 Checking the Security-related Settings

Windows Account Policy
This procedure applies only when work group management is conducted in either a standalone or
network-connected user environment. Setting conditions must be prescribed in the specification requirements.
This procedure does not apply if administration is conducted via a network domain server.
In Windows 2000, items related to the user manager can be checked by opening the [User and Password]
window from the [Control Panel]. For other items, open the [Local Security Policy] window from
[Administrative Tools] in the [Control Panel].
In Windows XP, the User Manager items are accessed via Control Panel. Start up [Administrative Tools],
[Computer Management] and [Local Users and Groups], and verify the settings. For the other items, start up
[Local Security Policies] included in [Administrative Tools].
Confirm that each policy meets the specified requirements, place a check in the checkbox and enter the result.
It the computer is managed by a network domain server, confirmation is made during the server computer IQ.
4-1-1-3 Settings Related to Network Connection

1. Network connection settings (only if network-connected)
Check the network settings in Windows to confirm that the internet protocol (TCP/IP) IP address and subnet
mask, the computer name and domain name or the workgroup name are properly set and record them. Note
that same IP addresses and computer names cannot be used within a network. Detailed procedures will vary
depending on the Windows version. Refer to online help or the Windows instruction manual.
2. Automatic system time adjustment for reference computer (if set)
In order to perform these procedures, a user with administrator rights for Windows needs to login. Perform
these procedures with the system administrator.
If Tasks will be used, open the Windows Control Panel and start up [Scheduled Tasks]. Verify that automatic
adjustment of the system time is recorded in the schedule as described in the example below. Capture this
screen (press the Prt Sc key while pressing the Alt key), paste this into the Windows Paint program and print
it. In addition, open the set *.bat file using Notepad, etc., print it and at the same time, confirm the name of
the reference computer.
Example) Set Date : 2003… Start Time: 12:00 / Interval Weekly, Monthly, Tuesday...
If the AT command will be used, start the DOS command prompt, and enter C:¥>AT. Verify that automatic
adjustment of the system time is recorded in the schedule as described in the example below.
Example) Daily Monday Tuesday ….. 12:00… C:¥NetTime.bat
Capture this screen (press the Prt Sc key while pressing the Alt key), paste this into the Windows Paint
program and print it. In addition, open the set *.bat file using Notepad, etc., print it and at the same time,
confirm the name of the reference computer.
4-1-2 Computer Date and Time
Check that the computer date and time setting is correct. Double-click [Date/Time] in Control Panel to
display the [Date/Time Properties] window. Check that the date and time are correct. Check the time against
an accurate clock, such as the telephone time service.
(Criteria) Date and time are correct.

4-2 UVProbe Spectrophotometer Control Software

4-2-1 Appearance and Installation Check
1. Boot up the computer.
2. Visually check the CD-ROM for damage, uncleanliness or any other abnormality.
3. Install*1) the Shimadzu User Authentication Tool by following the procedures indicated in the “Installing
UVProbe” section, located in the “Introduction” chapter of the UVProbe Instruction Manual (Tutorial), and
confirm that installation finishes normally.
4. Install UVProbe and confirm that installation finishes normally.
5. Perform an alteration check by following procedures 4.2.3 and enter the version number.
*1) The Shimadzu User Authentication Tool software is included in the optional CLASS-Agent software. If the CLASS-Agent
software will also be installed, compare the Shimadzu Authentication Tool version numbers, and install the software
having the newest version.
4-2-2 Installation Mode Check

When UVProbe is installed, either the GLP, security or normal mode can be selected. This procedure checks that
the installation was performed according to the specification requirements. If no requirements are specified,
simply check the mode status.
1. Launch UVProbe.
2. Choose [Options] from the [Edit] menu.
3. Check the UVProbe mode status.
4-2-3 Alteration Check
The alteration check confirms that the file size, file date/time and checksum for each file have not been changed
from the time of shipment from Shimadzu. This check verifies the integrity of the program.
From the Windows [Start] menu, choose [Programs], [Shimadzu], then [UVProbe – Check the Program Files].
When the login screen is displayed, log in using the “Admin” as the User ID and execute the software (If
UVProbe is installed in the Normal mode, leave the password blank.). When the [Program Alteration Check]
screen is displayed, select UVProbe*1. Click the [Check] button in the [Program Alteration Check] screen. Next,
click the [Execute] button. The files will be compared and the results of whether there are any alterations will be
displayed. Click [Notepad] to print and attach the alteration check results. In addition, enter the version
information in section 4-2-1. Similarly, also check the Shimadzu User Authentication Tool program.
*1) If 2 UVProbe lists are displayed on the screen, be sure to select the one in which the version numbers match.
Example) If Supplemental Disk Ver2.00SU1 is installed, select “UVProbe Ver.2.00SU1”.
(Criteria) All items displayed as “PASS”.
4-2-4 Security Settings Check
This procedure is applicable only if UVProbe is installed in Security or GLP mode, in which the setting
conditions must be specified in the requirement specifications beforehand.
Since this procedure can only be conducted by a user logged into Windows with Administrator authority, conduct
the procedure together with the system administrator.
From the Windows [Start] menu, choose [Settings], then [Control Panel]. When the control panel appears, launch
the [Shimadzu User Authentication Tool]. Click [Configuration Settings] and, after logging in, confirm that the
database name shown at the bottom of the screen is as planned. In addition, check that the password minimum
length limit, password validity period and other settings have been set as planned.

4-3 UV-VIS Spectrophotometer UV-1700

1. Check the external appearance of the unit for scratches, dirt, and other abnormalities.
2. Verify that the unit installation, power connections and wiring have been performed correctly according to
the corresponding descriptions in “1.3 Power Connections” of the UV-1700 Series instruction manual
(Installation / Maintenance Guide).
3. Turn on the UV-1700.
4. Check the ROM version number at the lower right of the initialization screen.
4-4 UV-VIS Spectrophotometer UV-1800

the corresponding descriptions in “2. Installation” of the UV-1800 Series instruction manual (Installation /
Maintenance Guide).
3. Turn on the UV-1800.
4. Check the ROM version number at the lower right of the initialization screen.
4-5 UV-VIS Spectrophotometer UV-1600PC/UV-1650PC

2. Confirm that the equipment installation, power supply connection and equipment wiring have been
performed properly in accordance with “Chapter 1 Installation” of the UV-1601PC series Instruction
Manual (Installation and Maintenance) and the “Information for users who purchased the UV-1650PC”
booklet included.
3. Launch UVProbe and register the equipment it will control. From the [Instrument] menu, click [Add] and
follow the Add Equipment wizard to select “UV-1601 series” as the equipment type and enter the
equipment name, model name and serial number.
4. Turn on the spectrophotometer.
5. Click the [Connect] button for one of UVProbe’s measurement modules (spectrum, kinetics or
photometrics) and begin communicating with the equipment.
6. The initial spectrophotometer settings display will appear on the screen and the setting and diagnostics for
each item will start.
7. The program checksum value is shown on the upper left side of the initial settings screen. Confirm the
equipment firmware version referring to the additional information.
4-6 UV-VIS Spectrophotometer UV-2401PC/UV-2450

performed properly in accordance with “Chapter 1 Installation” of the UV-2401/2501 series Instruction
Manual (Installation and Maintenance) and the “Information for users who purchased the UV-2450/2550”
booklet included.
follow the Add Equipment wizard to select “UV-2401PC series” as the equipment type and enter the

4-7 UV-VIS Spectrophotometer UV-2501PC/UV-2550

performed properly by following the “Chapter 1 Installation” section of the UV-2401/2501 series
Instruction Manual (Installation and Maintenance) and the “Information for users who purchased the
UV-2450/2550” booklet included.
follow the Add Equipment wizard to select “UV-2501PC series” as the equipment type and enter the
4-8 UV-VIS-NIR Spectrophotometer UV-3600

performed properly by following the “Chapter 1 Installation” section of the UV-3600 Instruction Manual
booklet included.
follow the Add Equipment wizard to select “UV-3600 series” as the equipment type and enter the
4-9 Syringe Sipper N/CN

2. Confirm that the equipment installation, plumbing and wiring have been performed properly in accordance
with “4. Installation” in the Syringe Sipper N/CN Instruction Manual.
4-10 Auto Sample Changer ASC-5

2. Confirm that the equipment installation, power supply connection, plumbing and wiring have been
performed properly in accordance with “1. Installation” in the ASC-5 Instruction Manual.
3. Turn on the ASC-5.
4. The LEDs indicate the program’s checksum value (flashing). Note the checksum value and confirm the
version referring to the additional information below.
4-11 DIS-1200 Elution Test 6-Cell Holder

2. Verify that the unit installation, tubing connections and wiring have been performed correctly according
to”2. Flow Cell Installation”, “4. Installation in UV-1601” and “5. 6-Cell Tube Pump Connections” of the
DIS-1200 Instruction Manual.

4-12 DIS-8 Elution Test 6-Cell Holder

2. Verify that the unit installation, tubing connections and wiring have been performed correctly according to
“3. Installation” in the DIS-8 Instruction Manual.
4-13 Cell Positioner CPS-240 A/B

1. Confirm that the equipment installation, power supply connection and wiring have been performed properly
in accordance with “2. Installation” in the CPS-240A/B Instruction Manual. For the CPS-240B model,
check that the plumbing has been properly performed.
4-14 Thermoelectrically Temperature Controlled Cell Holder TCC-240A

2. Verify that the equipment installation, power supply connection and wiring have been performed properly
in accordance with “2. Installation” in the TCC-240A Instruction Manual.
4-15 HCP-1C Screen Copy Printer

HCP-1C Instruction Manual.
4-16 DPU-414 Screen Copy Printer

DPU-414 Instruction Manual.
4-17 MPU Screen Copy Printer

MPU Instruction Manual.
5.
4-18 ESC/P Compatible Screen Copy Printer

printer’s instruction manual.
4-19 PCL Compatible Screen Copy Printer

printer’s instruction manual.

4-20 Time Course (Multi λ) Program Pack

1. Check the external appearance of the program pack for scratches, warpage, and other abnormalities.
2. After confirming that the spectrophotometer initialization operation is completed, insert the program pack
into the slot.
3. While the mode selection screen is displayed, press the [F2] key (IC Card).
4. Select “3. Program Pack Check” in the data/program pack management screen.
5. Check the displayed program version number.
6. Press the [PRINT] key to print a hard copy of the result screen.
4-21 DNA/Protein Quantitation Program Pack

into the slot.
4-22 Protein Quantitation Program Pack

into the slot.

4-23 Class-Agent Software

2. Check the CD-ROM visually for damage, uncleanliness or any other abnormality.
3. Confirm that the Shimadzu User Authentication Tool has already been installed.
4. Install the Agent-Manager software by following the procedure in the Class-Agent Instruction Manual
and check that the installation is properly completed.
5. Install UVProbe-Agent and check that installation is properly completed.
6. If necessary, install another software and confirm that installation is completed normally.
7. Perform the Alteration Check according to procedure 4.23.3 and enter the version number.
4-23-2 Installation Mode Check

When installing the Agent software, either the ER/ES or the normal mode can be selected. This procedure checks
that installation was performed according to specification requirements. If the specifications do not provide
requirements, simply confirm the mode status. Launch the Agent Manager. The login screen will appear and ask
for user ID and password input. Press the [Cancel] button. The mode can be confirmed from the mode displayed
in the lower right side of the screen.
The alteration check confirms that the file size, file date/time and checksum for each file have not been changed
from the time of shipment from Shimadzu. This check verifies the validity of the program. Place a check mark in
the box next to the name of the program to be used and perform the alteration check for each of them.
It is necessary to have a user registered with [Execute Validation] rights with respect to CLASS-Agent Manager
in order to perform this procedure. It is also necessary for the Operational Qualification (OQ) procedure to have
an OQ user registered. Please refer to the appropriate information.
From the Windows [Start] menu, choose [Programs], [CLASS-Agent Software], then [Program Alteration
Check]. When the login screen appears, login by entering an OQ user ID and password. When the [Program
Alteration Check] screen appears, select the program to check. Click the [Check] button in the [Program
Alteration Check] window. Next, click the [Execute] button. The files will be compared and the results of
whether there are any alterations will be displayed. Click [Notepad] to print and attach the alteration check
results. In addition, enter the version information. Similarly check other programs installed.
(Criteria) <<Integrity Check Passed>> is displayed.

4-24 Validation Software Package

3. Install the Validation Software by following the procedures included in “2. Parts Inspection and
Installation” in the Validation Software Package Instruction Manual and confirm that installation is
completed properly.
4. Perform the Alteration Check according to the procedure of 4.24.2, and enter the version number.

The alteration check checks whether the file size, file date, and checksum of each installed file has changed from
the status as supplied by Shimadzu. This check verifies the program validity.
Select the Windows [Start] button, and then select [Programs]-> [Shimadzu]-> [UVPC PerfVal – Program
Alteration Check] in that order. If the login screen is displayed, log in using “Admin” as the User ID and execute
the software (If UVProbe is installed in the Normal mode, leave the password blank.). When the [Program
Alteration Check] screen is displayed, select “UVPC Validation Software” to highlight it. Click the [Check]
button in the [Program Alteration Check] screen. Then click the [Run] button. The program alteration check is
conducted by comparing files, and the results are displayed. Click [Notepad] to print the results of the file
alteration check results, and append the printout of the results. Enter the version information.
* If the software is installed on the same PC as UVProbe, “User Authentication Tool” is displayed in the “Program
Alteration Check” screen, however, do not select this item here because the alteration check was executed for this item in
section 4-2-3.
(Criteria) All items displayed as “OK”.
4-25 Color Measurement Software COL-UVPC

3. Install the Color Measurement software according to the procedure described in “2.2 Software Installation”
in the chapter “2. Parts Inspection and Installation” of the COL-UVPC Instruction Manual, and confirm
that the installation is completed normally.

Select the Windows [Start] button, and then select [Programs]-> [Color Measurement]-> [Program Alteration
Check] in that order. If the login screen is displayed, log in using “Admin” as the User ID and execute the
software (If UVProbe is installed in the Normal mode, leave the password blank.). When the [Program Alteration
Check] screen is displayed, select “UVCol VerX.XX” to highlight it. Click the [Check] button in the [Program
Alteration Check] screen. Then click the [Run] button. The program alteration check is conducted by comparing
files, and the results are displayed. Click [Notepad] to print the results of the file alteration check results, and
append the printout of the results. Enter the version information.
section 4-2-3.

4-26 Film Thickness Measurement Software FLM-UVPC

3. Install the Film Thickness Measurement software according to the procedure described in “2.2 Software
Installation” in the chapter “2. Parts Inspection and Installation” of the FLM-UVPC Instruction Manual,
and confirm that the installation is completed normally.

Select the Windows [Start] button, and then select [Programs]-> [Film Thickness Measurement]-> [Program
Alteration Check] in that order. If the login screen is displayed, log in using “Admin” as the User ID and execute
the software (If UVProbe is installed in the Normal mode, leave the password blank.). When the [Program
Alteration Check] screen is displayed, select “UVFilm VerX.XX” to highlight it. Click the [Check] button in the
[Program Alteration Check] screen. Then click the [Run] button. The program alteration check is conducted by
comparing files, and the results are displayed. Click [Notepad] to print the results of the file alteration check
results, and append the printout of the results. Enter the version information.
section 4-2-3.

Installation Qualification Equipment Management
5. Equipment Management
This section explains points for equipment control.
5-1 Control of Changes

The instruments, including the software and firmware versions, referred to in this document cannot be modified
or improved without the permission of Shimadzu Corporation.
5-2 Maintenance
The instruments referred to in this document must be correctly maintained in accordance with the instruction
manuals at the facility that has purchased them. The calibration data and the corresponding maintenance
procedures for each unit must be attached to the “Equipment Control Record” prepared by the customer. Simple
maintenance procedures can be performed in accordance with the instruction manual. Even after the guarantee
period has expired, Shimadzu Corporation can offer various maintenance contracts and performance inspection
services for GLP/GMP compliance. For detailed information about service contracts, contact Shimadzu service
representatives.
5-3 Spare Parts

Spare parts are listed in the instruction manuals. Shimadzu recommends that the customer keep the essential
spare parts at hand to minimize the downtime due to minor problems.
Page 26 of 29 Rev 3. 10
Installation Qualification Change List
6. Change List
When changing or deleting the contents of this document, or adding new information to this document, record
change list number, page number, reason, date, and name of the Performer in the Change List below, and obtain
the approval of the Reviewer and the Manager.
Change No: Enter the change number assigned in sequence from 1 onwards in accordance with
“1.3 Entries and Revisions”.
Page: Enter the page number in which the change, deletion or addition was made.
Reason: Enter the reason for the change, deletion or addition.
Date: Enter the date on which the change, deletion or addition was made.
Change
Page Reason Date Performer Reviewer Manager
No.

Change
No.

Change
No.

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SHIMADZU UV-VIS SPECTROPHOTOMETER

Installation Qualification Protocol

· Performer Signature Date

· Reviewer Signature Date

· Manager Signature Date

Page 2 of 29 Rev 3.10

Rev 3.10 Page 3 of 29

6. This document is comprised of 1. Definitions, 2. Preliminary Checks, 3. Pre-installation Qualification, 4.

Page 4 of 29 Rev 3.10

· Confirmation of Software and Firmware

Rev 3.10 Page 5 of 29

1-3 Entries and Revisions

2. Deletion and correction of mistakenly filled items

3. Changing or deleting steps, procedures or acceptance criteria

6. In the event of a Fail

Page 6 of 29 Rev 3.10

2-1 Reviewer Confirmation

2-2 Performer Identification & Approval

2.3 Product Specifications

3-1 Equipment List

3-2 Instruction Manuals

Management of Design Changes

Rev 3.10 Page 9 of 29

3-4 Installation Environment

3-4-1 Installation Environment

(Humidity) Humidity during operation must be within 20 to 80%.

(Other) Avoid exposure to air from air-conditioners.

3-4-2 Power Supply

(Connection) The instrument must be grounded.

Page 10 of 29 Rev 3.10

3-5 Equipment Information

3-5-2 UVProve Spectrophotometer Control Software

Rev 3.10 Page 11 of 29

The software versions that are supported are as follows.

3-5-4 Syringe Sipper N/CN

3-5-5 Auto Sample Changer ASC-5

3-5-6 Elution Test 6-Cell Holder DIS-1200

Page 12 of 29 Rev 3.10

3-5-8 Cell Positioner CPS-240A/B

*1 Installation space requirements include space for cables.

3-5-9 Thermoelectrically Temperature Controlled Cell Holder TCC-240A

*1 Installation space requirements include space for cables.

Rev 3.10 Page 13 of 29

3-5-11 ESC/P Compatible Screen Copy Printer

3-5-12 PCL Compatible Printer

3-5-13 Time Course (Multi λ) Program Pack

3-5-14 DNA/Protein Quantitation Program Pack

3-5-15 Protein Quantitation Program Pack

3-5-16 CLASS-Agent Software

Page 14 of 29 Rev 3.10

3-5-17 Validation Software Package

3-5-18 Color Measurement Software COL-UVPC

3-5-19 Film Thickness Measurement Software FLM-UVPC

Rev 3.10 Page 15 of 29

4-1 Personal Computer and Peripherals

4-1-1-1 Checking Computer Appearance, Connection, and Installed Software

1) Checking the Operating System Version