UV IQP ZEMA-0004B Rev310
UV IQP ZEMA-0004B Rev310
UV IQP ZEMA-0004B Rev310
Document No.
Installation Qualification
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.
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Certificate No.
(Shimadzu-certified Performer only)
Company
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Company
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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
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.
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.
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.
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.
2. Preliminary Checks
Rev 3. 10 Page 7 of 29
Installation Qualification Pre-installation Qualification
3. Pre-installation Qualification
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
Installation Qualification Pre-installation Qualification
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.
(Bench)
· Space Requirements: Listed in section 3-5 for each component
· Strength Requirements: Listed in section 3-5 for each component
(Frequency) 50/60 Hz
Power Power
Model Size (mm) Weight Frequency
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
* 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
Model Size (mm) Weight Frequency
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
* 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
Model Size (mm) Weight Frequency
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
* 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.
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.
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.
Page 16 of 29 Rev 3. 10
Installation Qualification Installation Qualification
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.
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.
5. Equipment Management
This section explains points for equipment control.
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.
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
Page Reason Date Performer Reviewer Manager
No.
Change
Page Reason Date Performer Reviewer Manager
No.