UV IQR ZEMA-1004B Rev310

ZEMA-1004B
Document No.
SHIMADZU UV-VIS SPECTROPHOTOMETER

UV-1700 / UV-1800 / 1650PC / 2450 / 2550 / 3600series
Installation Qualification
Installation Qualification Report

System Name
System ID No.
Installation Site
The undersigned performer reports that the Installation Qualification Protocol has been successfully completed for the
system stated above.
· Performer Signature Date
Print / /
Title
Company
The undersigned reviewer and manager report that the performer has completed the Installation Qualification Protocol
successfully.
· Reviewer Signature Date
Print / /
Title
Company
· Manager Signature Date
Print / /
Title
Company
Installation Qualification Table of Contents
Table of Contents
1. Definitions................................................................................................................................ 3
1-1 Documentation ............................................................................................................................... 3
1-2 Scope .............................................................................................................................................. 4
1-3 Entries and Revisions ..................................................................................................................... 5
2. Preliminary Checks ................................................................................................................ 6
2-1 Reviewer Confirmation .................................................................................................................. 6
2-2 Performer Identification & Approval ............................................................................................. 7
3. Pre-installation Qualification................................................................................................. 9
3-1 Equipment List ............................................................................................................................... 9
3-2 Instruction Manuals ...................................................................................................................... 11
3-3 Installation Environment .............................................................................................................. 14
3-4 Equipment Information ................................................................................................................ 15
4. Installation Qualification ..................................................................................................... 21
5. Change List ........................................................................................................................... 31
6. Attached Documents ............................................................................................................. 34
Rev 3.10 Page 2 of 34

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 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 check each unit and execute inspections using the protocol described in Installation
Qualification Protocol (Document No. ). After checking all items, the Performer shall sign and
date the cover sheet of this document and submit this document as a report.
(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 the performance of each inspection
(Pre-installation Qualification, Installation Qualification and Equipment Management), the Reviewer shall
check their results. After checking all items, the Reviewer shall sign and date the cover sheet of this document
as approval of the Installation Qualification.
5. The Manager shall first check the content of this entire document. After the performance of all installation
qualification protocols, the Manager shall check their results. 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.
6. This document is comprised of 1. Definitions, 2. Preliminary Checks, 3. Pre-installation Qualification, 4.

Installation Qualification, 5. Change List, and 6. Attached Documents. 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
This Installation Qualification shall apply to the equipment installed at the following site.
(Address):
(Company):
(Department):
(Installation Site):
(System ID No.):
(Product Model Name)
(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 in Section 4 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.
If necessary, pages can be added. To add a page, record the “Change List No. ” on the page and date/ sign it.
Add an alphabetical letter (starting from A) to the page number (e.g., 5-A), and insert the added page after the
relevant page. Add the page number of the added page to the Table of Contents and record it in the Change List.
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.
Rev 3. 10 Page 5 of 34
Installation Qualification Preliminary Checks
2. Preliminary Checks
2-1 Reviewer Confirmation

Before conducting this inspection, enter the name of the Reviewer designated by the Manager.
Reviewer
Name:
Title: Date: / /
Use the spaces below if more than one Reviewer is to be set. If the spaces are not used, place a
checkmark in the “Not Applicable” checkbox.
Reviewer 2 (Not applicable)
Name:
Title: Date: / /
Reviewer 3 (Not applicable)
Name:
Title: Date: / /

2-2 Performer Identification & Approval

Identify and approve the Performer. Choose the entry section according to the way in which the Performer is
selected.
If revisions are to be made to the document by Performers other than the persons certified in the table below,
make a note of the fact that the Performer has been changed (qualification certificate number included) in “5.
Change List”.
If the Performer is a service engineer authorized by Shimadzu Representative, complete the following.
This is to certify that the below-signed person has received training in the Quality Assurance Department of
the Analytical & Measuring Instruments Division of Shimadzu Corporation. The person has been certified by
the General Manager of the Quality Assurance Department as a qualified IQ/OQ Inspector, as proven by the
certificate. The person performs the Installation Qualification Protocol as the Performer.
Performer
Name: Date: / /
Title:
Company name:
Certificate No.:
Signature:
Use the spaces below if more than one Performer is to be set. If the spaces are not used, place a checkmark in
the “Not Applicable” checkbox.
Performer 2 (Not applicable)
Name: Date: / /
Title:
Company name:
Certificate No.:
Signature:
Performer 3 (Not applicable)
Name: Date: / /
Title:
Company name:
Certificate No.:
Signature:
The above-signed persons are hereby recognized as Certified IQ/OQ Inspectors and approved to perform the
Installation Qualification Protocol as the Performer.
Reviewer
Signature: Date: / /
Manager
If the Performer has been appointed by the Manager, complete the following.
Performer
Name: Date: / /
Title:
Company name:
Signature:
The above-signed person is hereby recognized as a Certified IQ/OQ Inspector and approved to perform the
Installation Qualification Protocol as the Performer.
Reviewer
Manager

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 boxes 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.
<Equipment Configuration>
Not Serial No.

Applicable
Applicable Model Name
UV-1700
UV-1800
UV-1650PC
UV-2450
UV-2550
UV-3600
UV-1601PC
UV-2401PC
UV-2501PC
PC set
Control Personal Computer
Display
Printer
Syringe Sipper N
Syringe Sipper CN
ASC-5
DIS-1200
DIS-8
CPS-240 A
CPS-240 B
TCC-240 A
HCP-1C
DPU-414
ESC/P Compatible Screen Copy Printer
Time Course (Multi λ) Program Pack
DNA/Protein Quantitation Program Pack
Protein Quantitation Program Pack
Not Model Name Serial No.

Applicable
Applicable
UVProbe Software PKG

UVProbe-Agent Software
Validation Software Package N/A
COL-UVPC (Color Measurement) Software N/A
FLM-UVPC N/A
(Film Thickness Measurement) Software
Other Options

We hereby approve the system configuration specified above.
Performer (signature) Date: / /

Reviewer (signature) Date: / /

3-2 Instruction Manuals
Not Rev. Storage Location

Applicable
Applicable Instruction Manual P/N
Symbol A B C
UV-1700 Series User’s System 206-94783

Guide
UV-1700 Series Operation Guide 206-94785
UV-1800 System User’s Guide 206-97040
UV-1800 Operation Guide 206-97042
UV-1601PC Instruction Manual 206-94375 N/A

User’s System Guide
Information for users who purchased
the UV-1650PC 206-94647
UV-2401/2501 Series Instruction 206-94376

Manual User’s System Guide
Information for users who purchased 206-94649

the UV-2450/2550
UV-3600 Instruction Manual 206-95518
UVProbe Tutorial 206-94459
Shimadzu User Authentication Tool
Easy Operation Procedure for
206-94653
Photometric Module
UV SOP 206-81758
PC Set Instruction Manual
PC and peripherals N/A N/A
Syringe Sipper N/CN 206-94651
ASC-5 206-96026
CPS-240A/B 206-96225
TCC-240A 206-96227
DIS-1200 206-93060
DIS-8 206-94543
HCP-1 206-96368
DPU-414 206-94803
MPU 206-97124
Time Course (Multi λ) Program Pack 206-96956
DNA/Protein Quantitation Program
206-93104
Pack
Protein Quantitation Program Pack 206-93102
CLASS Agent Installation Procedures
Rev 3. 10 Page 11 of 34
Not Rev. Storage Location

Applicable
Applicable Instruction Manual P/N
Symbol A B C
UVProbe Agent Software
CLASS Agent Manager
Program List
UVPC Validation Software 206-95012
Color Measurement Software
206-94284
Film Thickness Measurement
206-94321
Software

Storage Site
A
B
C
The following signees have verified the storage locations of the above instruction manuals.


3-2-1 Certificate of Compliance and Inspection Result Sheet

Shimadzu Corporation provides the following certificates for each unit.
· Certificate of Compliance
· Inspection Report (Spectrophometer unit only)
Place a checkmark in the “Applicable” box if the unit is included in the system to be inspected and verify that the
“Certificate of Compliance” and “Inspection Report” have been supplied. If the unit is not included in the system,
place a checkmark in the “Not Applicable” box.
Not Certificate of
Applicable Applicable Model Name Compliance Inspection Report
UV-1700
UV-1800
UV-1650PC
UV-2450
UV-2550
UV-3600 N/A N/A
UV-1601PC N/A
UV-2401PC N/A
UV-2501PC N/A
UVProbe (Ver. ) N/A
CLASS-Agent (Ver. ) N/A
Validation Software (Ver. ) N/A
COL-UVPC (Ver. ) N/A
FLM-UVPC (Ver. ) N/A

Store the Certificate of Compliance and the Inspection Report together with this document.

Rev 3. 10 Page 13 of 34
3-3 Installation Environment

The following environment must be provided for the equipment to function properly.
3-3-1 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.
3-3-2 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
two-prong type.)

3-4 Equipment Information
Accessories
Confirm Model Name (Product Name) Component ID
Pass Fail
UV-1700 No
UV-1800 No
UV-1601PC/1650PC No
UV-2401PC/2450PC No
UV-2501PC/2550 No
UV-3600 No
UV Probe No
Syringe Sipper N/CN No
Auto Sample Changer ASC-5 No
DIS-1200 No
DIS-8 No
CPS-240A/B No
TCC-240A No
HCP-1C No
DPU-414 No
MPU No
ESC/P Compatible No
PCL Compatible No
Time Course (Multi λ) Program Pack No
DNA/Protein Quantitation Program Pack No
Protein Quantitation Program Pack No
No
No
No
No
No
We hereby approve the equipment information above.

Rev 3. 10 Page 15 of 34
Computer and Peripherals

Applicable Not Applicable
Equipment Information
Product Name: Personal Computer
Manufacturer:
Model Name:
CPU Model Name( ) Clock speed ( Hz)
RAM ( ) MB
HDD ( ) Bytes
Component ID: No
Power Source: AC V
Frequency: Hz
Power Consumption:
Product Name: Display Yes No
Manufacturer:
Model Name:
Component ID: No
Power Source: AC V
Frequency: Hz
Power Consumption:
Product Name: Printer Yes No
Manufacturer:
Model Name:
Component ID: No
Power Source: AC V
Frequency: Hz
Power Consumption:

Product Name: Yes No
Manufacturer:
Model Name:
Component ID: No
Power Source: AC V
Frequency: Hz
Power Consumption:
Manufacturer:
Model Name:
Component ID: No
Power Source: AC V
Frequency: Hz
Power Consumption:
Manufacturer:
Model Name:
Component ID: No
Power Source: AC V
Frequency: Hz
Power Consumption:

Rev 3. 10 Page 17 of 34
UVProbe Spectrophotometer Control Software

Product Name: UVProbe

Manufacturer: Shimadzu Corporation
( Not required when provided
Software Product No. (P/N): with the instrument)
UVProbe (Ver. )
Update Disk
Yes (Ver. )
P/N
No
Component ID: No
CLASS-Agent Software
Product Name: CLASS-Agent

Software Product No. (P/N):
CLASS-Agent (Ver. )
Install CD-ROM P/N
Update Disk
Yes (Ver. )
P/N
No
Component ID: No


Validation Software
Product Name: Validation Software Package

Validation Software (Ver. )
Install CD-ROM P/N
Update Disk
Yes (Ver. )
P/N
No
Component ID: No
Color Measurement Software COL-UVPC

Product Name: Color Measurement Software COL-UVPC

COL-UVPC (Ver. )
Install CD-ROM P/N
Update Disk
Yes (Ver. )
P/N
No
Component ID: No

Rev 3. 10 Page 19 of 34
Film Thickness Measurement Software FLM-UVPC

Product Name: Film Thickness Measurement Software FLM-UVPC

FLM-UVPC (Ver. )
Install CD-ROM P/N
Update Disk
Yes (Ver. )
P/N
No
Component ID: No


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.
Item
Not
Applicable Applicable Model Name Appearance Installation
Pass Fail Pass Fail Ver.
UV-1700
UV-1800
UV-1601PC/1650PC
UV-2401PC/2450PC
UV-2501PC/2550
UV-3600
UV Probe
Syringe Sipper N/CN N/A
Auto Sample Changer ASC-5
DIS-1200 N/A
DIS-8 N/A
CPS-240A/B N/A
TCC-240A N/A
HCP-1C N/A
DPU-414 N/A
MPU N/A
ESC/P Compatible
PCL Compatible
Time Course (Multi λ) Program Pack
DNA/Protein Quantitation Program

Pack
Protein Quantitation Program Pack



Personal Computer and Peripherals

Personal Computer Setup
· Checking Computer Appearance, Connection, and Installed Software
(Result) Item Pass Fail

1. Appearance
2. Installation
3-1. OS Version Windows2000 Ver. (SP )

Windows XP Ver. (SP )
3-2. Printer Driver Installation
Printer Driver Version Ver.
3-3. Installed Software

UVProbe Ver.
Other ( ) Ver.
Other ( ) Ver.
Other ( ) Ver.
Other ( ) Ver.
Other ( ) Ver.
Other ( ) Ver.
Other ( ) Ver.
Other ( ) Ver.
Other ( ) Ver.
4. Hard Disk File System

File System Suitability: Suitable Unsuitable No Requirements Specified
C drive: (Spec. Req.: )
drive: (Spec. Req.: )


· Security Settings Check
(Result) Policy Settings

Settings Suitability: Suitable
Unsuitable
Not Applicable
Requirements are not specified
(Reason Not Applicable: )
Item (Settings) (Required Spec.)

User Manager
(Account 1: )
User must change password at next login Valid Invalid ( Valid Invalid)
User cannot change password Valid Invalid ( Valid Invalid)
Password never expires Valid Invalid ( Valid Invalid)
Account is disabled Valid Invalid ( Valid Invalid)
(Account 2: )
(Account 3: )
(Account 4: )
(Account 5: )
(Continued on next page)

Rev 3. 10 Page 23 of 34
(Result) Item (Settings) (Required Spec.)

Account Policy
Password length ( ) ( )
Password change prohibited period ( ) ( )
Password valid period ( ) ( )
Password log ( ) ( )
Password complexity ( ) ( )
Account lock-out threshold value ( ) ( )
Reset lock-out count ( ) ( )
Lock-out period ( ) ( )
With PIN number returned to original ( ) ( )
state, save all domain user passwords
User Authority Allocation

Change system time
(Permitted account)
Security Options
Interactive login
: Ctrl+Ald+Del not required Valid Invalid Valid Invalid
Interactive login
: Do not display last user’s name Valid Invalid Valid Invalid
Audit Policy
Account login event Pass Fail ( Pass Fail
Not audited Not audited)
Account management Pass Fail ( Pass Fail
Object access Pass Fail ( Pass Fail
System event Pass Fail ( Pass Fail
Directory service access Pass Fail ( Pass Fail
Process tracking Pass Fail ( Pass Fail
Change policy Pass Fail ( Pass Fail
Login event Pass Fail ( Pass Fail
Use privileges Pass Fail ( Pass Fail


· Network Connections Settings Check
(Result) 1. Check network connection settings

Settings Suitability: Suitable Unsuitable Requirements not specified
(Reason why not applicable: )
Computer Name: (Required Spec.: )
Computer name duplication: No duplication Duplication present
I IP Address: (Required Spec.: )
IP Address duplication: No duplication Duplication present
Subnet Mask
Domain Name: (Required Spec.: )
Workgroup Name: (Required Spec.: )
2. Automatically Synchronize Time to Reference Computer

Settings Suitability: Suitable Unsuitable Requirements not specified
Time is synchronized (Ref. Computer Name: )
Time is not synchronized
(Required Spec. Synchronized Not synchronized)
Computer Date and Time
(Result) Item Computer Reference Pass Fail

Computer’s date ( / / ) ( / / )
Computer’s time ( : : ) ( : : )
Permitted range ( )

Rev 3. 10 Page 25 of 34
UVProbe Spectrophotometer Control Software

Appearance and Installation Check

Appearance
Shimadzu User Authentication Tool Installation
UVProbe Installation
Shimadzu User Authentication Tool Version:
UVProbe Version:
Installation Mode Check
(Result) Item
UVProbe Installation Mode
Installation Mode Suitability: Suitable Unsuitable
Requirements not specified
Application Mode: (Required Spec.: )
Alteration Check

UVProbe Ver.
Shimadzu User Authentication Tool
* Mark the installed program name and whether it passed or failed. Also, attach the printed results.


Security Settings Check
(Result) Item
Shimadzu User Authentication Tool Settings Check
( Not applicable- Shimadzu User Authentication Tool not used)
Settings Suitability: (Required Spec.)
Suitable Unsuitable Requirements not specified
Database connection destination name: ( )
Minimum Password Length: characters or more ( )
Password Validity Period: days ( )
Password Change Lock-out Period: days ( )
Same Password Permitted Not checked Checked ( )
If not checked, number of times password stored :_________times
Password meets complexity requirements Not checked Checked ( )
User must change password at next login Not checked Checked ( )
User Indefinite Lock-out Not checked Checked ( )
User Lock-out Period: minutes ( )
Failed User Logon Attempts: Lock-out after attempts. ( )
PC Lock-out Period: minutes ( )
Failed PC Logon Attempts: Lock-out after attempts. ( )
Auto Sample Changer ASC-5


Appearance
Installation
Checksum Value:
Version:
<Additional · The Relationship Between the Firmware Version and Checksum Value
Information> The relationship between the ASC-5 Auto Sample Changer firmware checksum value and
version number is shown below.
Checksum Value Version
02A ; Ver 1.00

Rev 3. 10 Page 27 of 34
Class-Agent Software

Outline
Agent-Manager Installation
UVProbe-Agent Installation
( ) Installation
( ) Installation
( ) Installation
Agent-Manager Ver.
UVProbe-Agent Ver.
( ) Ver.
( ) Ver.
( ) Ver.
Installation Mode Check
(Result) 1. CLASS-Agent Installation Mode

Installation Suitability: Suitable Unsuitable Requirements not specified
Installation Mode: (Required Spec.: )
Alteration Check

CLASS-Agent Manager
UVProbe- Agent

* Enter the installed program name and whether it passed or failed. Also, attach the printed results.


Validation Software Package


Appearance
Installation
Version No.:
Alteration Check

UVPC Validation Software
* Attach the printed results.
Color Measurement Software COL-UVPC


Appearance
Installation
Version No.:
Alteration Check

UVColor

Rev 3. 10 Page 29 of 34
Film Thickness Measurement Software FLM-UVPC


Appearance
Installation
Version No.:
Alteration Check

UVFilm


Installation Qualification Change List
5. 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.
Rev 3. 10 Page 33 of 34
Installation Qualification Attached Documents
6. Attached Documents
Attached Item Description Page

Certificate of Compliance
3-5 Certificates
Inspection Report
4 Time Course (Multi λ) Program Pack
Version check Verification data Attachment 34 -
4 DNA/Protein Program Pack
4 Protein Quantitation Program Pack
4 PC Set/Personal computer and peripheral devices
Printer driver version check Verification data Attachment 34 -
Reference computer system time automatic Attachment 34 -
Verification data
adjustment
UV-VIS Spectrophotometer Control Software
4
UVProbe
Alteration Check Verification data Attachment 34 -
4 Class Agent software
4 Validation software
4 Color Measurement software COL-UVPC
4 Film Thickness software FLM-UVPC
* Number the attached data by adding an alphabetical letter (starting from A) to the final page number (e.g., Attachment
34-A-1/3 – A-3/3). Fill in the table above and attach the data to this document.


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ZEMA-1004B

SHIMADZU UV-VIS SPECTROPHOTOMETER

Installation Qualification Report

· Performer Signature Date

· Reviewer Signature Date

· Manager Signature Date

5. Change List ........................................................................................................................... 31

6. Attached Documents ............................................................................................................. 34

Rev 3.10 Page 2 of 34

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

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(Product Model Name)

(Scope of Installation Qualification)

· Confirmation of Software and Firmware

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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

2-1 Reviewer Confirmation

Reviewer 2 (Not applicable)

Reviewer 3 (Not applicable)

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2-2 Performer Identification & Approval

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3-1 Equipment List

Not Serial No.

Not Model Name Serial No.

UVProbe Software PKG

We hereby approve the system configuration specified above.

Performer (signature) Date: / /

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3-2 Instruction Manuals

Not Rev. Storage Location

UV-1700 Series User’s System 206-94783

UV-1601PC Instruction Manual 206-94375 N/A

UV-2401/2501 Series Instruction 206-94376

Information for users who purchased 206-94649

Not Rev. Storage Location

Performer (signature) Date: / /

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3-2-1 Certificate of Compliance and Inspection Result Sheet

UVProbe (Ver. ) N/A

CLASS-Agent (Ver. ) N/A

Validation Software (Ver. ) N/A

COL-UVPC (Ver. ) N/A

FLM-UVPC (Ver. ) N/A

Performer (signature) Date: / /

3-3 Installation Environment

3-3-1 Installation Environment

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

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

3-3-2 Power Supply

(Connection) The instrument must be grounded.

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3-4 Equipment Information

We hereby approve the equipment information above.

Performer (signature) Date: / /

Computer and Peripherals