PHARMA DEVILS

QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

INSTALLATION QUALIFICATION

FOR

COMPUTER SYSTEM OF

STABILITY-PC

System Name STABILITY-PC

System ID
Location QUALITY ASSURANCE
Effective Date

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

TABLE OF CONTENTS
1. PRE APPROVALS ....................................................................................................................... 3
2. SIGNATURE OF EXECUTOR.................................................................................................... 4
3. REVISION HISTORY .................................................................................................................. 4
4. OBJECTIVE ................................................................................................................................. 4
5. SCOPE ........................................................................................................................................... 5
6. SYSTEM DESCRIPTION ............................................................................................................ 5
7. ROLE AND RESPONSIBILITY .................................................................................................. 6
8. REFERENCES .............................................................................................................................. 7
9. DOCUMENTATION PROCEDURE ........................................................................................... 7
10. QUALIFICATION COMPLETION AND APPROVAL ............................................................ 8
11. ACCEPTANCE CRITERIA......................................................................................................... 8
12. INSTALLATION VERIFICATION TEST ................................................................................. 9
12.1 Identification of System Details .......................................................................................... 9
12.2 Verification of Master Documents ..................................................................................... 10
12.3 Verification of Capacity Requirement ................................................................................ 11
12.4 Verification of Hardware Components ............................................................................... 12
12.5 Verification of Software Components ................................................................................ 14
12.6 Verification of Physical and Logical Security Control ........................................................ 16
12.7 Verification of Test Instruments Calibration and Traceability ............................................ 18
12.8 Verification of Power Utility .............................................................................................. 19
12.9 Verification of Environment Condition .............................................................................. 20
12.10 Verification Of Communication Link Between Server To Computer System ..................... 21
12.11 Verification of General System Installation ........................................................................ 22
12.12 Verification of Standard Operating Procedure .................................................................... 23
13. INSTALLATION QUALIFICATION TEST STATUS ............................................................ 24
14. DISCREPANCIES HANDLING DURING COMPUTER SYSTEM QUALIFICATION ...... 24
15. DISCREPANCY AND CORRECTIVE ACTION FORM ........................................................ 25
16. ABBREVIATION ....................................................................................................................... 25
17. ATTACHMENT SUMMARY .................................................................................................... 27
18. INSTALLATION QUALIFICATION SUMMARY & CONCLUSION .................................. 27
19. POST APPROVALS ................................................................................................................... 28

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

1. PRE APPROVALS
The signature listed below indicates the preapproval of this installation qualification. This approval is
joint responsibility of listed functional areas.

DOCUMENT DEVELOPMENT SIGN / DATE

Name : __________________
Designation : __________________

DOCUMENT REVIEW AND APPROVAL

Sign / Date : __________________
Name : __________________
Designation : __________________
Engineering

Sign / Date : __________________

Name : __________________
Designation : __________________
IT

Sign / Date : __________________

Name : __________________
Designation : __________________
Quality Assurance

DOCUMENT APPROVAL
Sign / Date : __________________
Name : __________________
Designation : __________________
Quality Assurance

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

2. SIGNATURE OF EXECUTOR
All the executer involved in this document have to sign within prescribed format given below.
M/s…..

Name Designation Signature Initial Date

M/s…..

Name Designation Signature Initial Date

3. REVISION HISTORY

Date Supersedes Reason for Revision

4. OBJECTIVE
The objective of installation qualification is to collect the sufficient data pertaining to Computer
System of STABILITY-PC installed after modification at M/s……..and define the qualification
requirements and acceptance criteria for the Computer System STABILITY-PC
supporting automation of the system. Successful completion of these qualification requirements will
provide assurance that the Computer System of STABILITY-PC
for the M/s……………..was installed successfully.

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

5. SCOPE
This document is applicable to validation for Hardware and Software system of STABILITY-PC
installed after modification at M/s……………This installation qualification shall define the
documentation, references and acceptance criteria for validation of Hardware and Software system of
STABILITY-PC is installed in accordance with the guidelines laid down by the manufacturer of the
system.

6. SYSTEM DESCRIPTION
Computer system of STABILITY-PC defines the controlling of Stability chamber connected to the
system. The CS software of stability chamber is a communication software for data management. The
operator interface is carried out by CS screen. The CS is used to feed required parameters and set
points in the system during operation. The system is connected to data server for printing and data
backup. The system is secured by IT through password only within the system.

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

7. ROLE AND RESPONSIBILITY
The validation team comprising of representative from each of the following departments should be
responsible for overall compliance with this validation plan.

Department Responsibilities
 To collect the necessary data for installation qualification activities.
 To prepare and execute the installation qualification in coordination with
engineering, validation and quality assurance team.
Validation Agency
 Comply with regulatory / Guidelines / Standards / validation plan requirements
throughout the validation life cycle.
 To submit installation qualification for approval.

Engineering  To provide the necessary data for installation qualification activities.

 To review the installation qualification.

IT  To provide the necessary data for installation qualification activities.

 To review the installation qualification.

Quality Assurance  To provide the necessary data for installation qualification activities.
 To review the installation qualification.
Quality Assurance  To approve and authorized the installation qualification.

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

8. REFERENCES
The publication listed below form part of this reference documents. Each publication shall have
latest revision in effect on the date of this document is approved for execution.
Good Automated Manufacturing Practices, Version 5, Guideline
GAMP 5 Document for Automated Systems from International Society of
Pharmaceutical Engineering
21 Code of Federal Current Good Manufacturing Practice in Manufacturing, Processing,
Regulations (CFR), Part 210 Packing, or Holding off Drugs; General
21 Code of Federal Current Good Manufacturing Practice for finished Pharmaceuticals
Regulations (CFR), Part 211
21 Code of Federal Regulations (CFR), Part 11
21 Code of Federal
Electronic Records, Electronic Signatures, Final Rule Electronic
Regulations (CFR), Part 11
Submissions; Establishment of Public Docket, Notice
International Conference of Harmonization (ICH) quality risk
ICH Q9
assessment Q9
Laying down the principles and guidelines of GMP in respect of
EU GMP
medicinal products for human use.
SRS System Requirement Specification
WHO Appendix 5, validation of computerized systems.

9. DOCUMENTATION PROCEDURE
 Qualification activities will be performed as defined in the approved document.
 All documentation will be completed during the execution of the qualification.
 Recording of information will be made in permanent ink.
 Fill out complete information in the verification table provided.
 Do not keep any space blank. Mark blank space with a single line throughout the appropriate
space with mentioning NA (Not Applicable) and put initial and date.
 Correct the mistakes by drawing a single line through the incorrect data, recording the correct
information and then initialing and dating the change.

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

10. QUALIFICATION COMPLETION AND APPROVAL
 Verify that all tests required by qualification are completed and attached.
 Verify that all amendments and discrepancies are documented, approved and attached.
 If all items in the qualification for the validation to Hardware and Software system of
STABILITY-PC been reviewed and found to be acceptable, sign the corresponding block in the
qualification completion and approval form.

11. ACCEPTANCE CRITERIA

 Installation completion as per manufacturer’s recommendations & cGMP requirements.
 Installation of major components as per the design specifications.
 The supply of all necessary documentation from manufacturer.

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

12. INSTALLATION VERIFICATION TEST
12.1 Identification of System Details

Objective : This test sheet is intended to verification of equipment details.

Tools Required : Not Applicable
Procedure : 1. Record Equipment Name
2. Record Identification No.
3. Record Equipment Location
Acceptance : Data recorded from the equipment shall match with the data specified in
Criteria verification table.

Verification Table:

Discrepancy?
Equipment Details Specified As As observed
(Y/N)
Equipment Name STABILITY-PC
Identification No.
Location QUALITY ASSURANCE

Remarks:
______________________________________________________________________________

______________________________________________________________________________

Meet the acceptance Criteria [ ] Yes [ ] No

Checked by : ______________ Date : _________________

Verified by : ______________ Date : _________________

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

12.2 Verification of Master Documents
Objective : To verify the availability of related master documents.
Tools Required : Not Applicable
Procedure : 1. Verify Documents Name.
2. Verify Documents Reference.
3. Verify Documents Availability.
Acceptance : Documents should be available.
Criteria

Verification Table:

Availability Verified Discrepancy?

Documents Name Documents Reference
(Yes/No) (Yes/No) (Y/N)
SRS -
Operational Manual -
BOM Refer attachment No. 1

Remarks:
______________________________________________________________________________

______________________________________________________________________________

Meet the acceptance Criteria [ ] Yes [ ] No

Checked by : ______________ Date : _________________

Verified by : ______________ Date : _________________

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

12.3 Verification of Capacity Requirement

Objective : To verify the processing capacity of Computer System

Tools required : Not Applicable
Procedure : Physical verification of Capacity Requirement as per SRS
1. No more than 50% of the installed hard disk capacity in PC
components should be consumed by installed software.
2. Historical data storage capacity should allow for online retrieval
of at forever of any historical data.
Acceptance : 1. Capacity Requirement of the control system shall match with
criteria SRS.

Verification Table:
Actual Discrepancy?
S. No. Item Name Expected (Y/N)
(Yes/No)
Not more than 50% of the
1 Processing Power
processing capacity

Not more than 50% of the

2 Memory
installed physical memory

Local Electronic Not more than 50 % should be

3
Storage consumed by installed software

Remarks:
______________________________________________________________________________

______________________________________________________________________________

Meet the acceptance Criteria [ ] Yes [ ] No

Checked by : ______________ Date : _________________

Verified by : ______________ Date : _________________

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

12.4 Verification of Hardware Components
Objective : To verify the installed hardware components as per the SRS.
Tools Required : Not Applicable
Procedure : 1. Verify Hardware Name.
2. Verify Hardware Make/ Assemble By
3. Verify Hardware Model No./Specification
Acceptance : Installed hardware component should match with SRS.
Criteria

Verification Table:
Make/ Model Installation Discrepancy?
Name Qty.
Assemble By No./Specification (Yes/No) (Y/N)
Monitor Acer V196HQC 01
CPU Acer Veriton-IE4066 01
Keyboard Acer NA 01
Mouse Acer NA 01
Emerson
UPS Network 20 kVA 01
System
RAM Acer 4 GB 01
Pentium(R) G3260
Processor Intel 01
3.30 GHz
Printer Canon 3300 01
Thermolab
Stability Chamber scientific SG1K00A501 03
equipmants

Verification Table: Communication Port

Installation Discrepancy?
S. No. Port Type Qty.
(Yes/No) (Y/N)
1 USB 2
2 Ethernet 2

Remarks:
______________________________________________________________________________

______________________________________________________________________________

Meet the acceptance Criteria [ ] Yes [ ] No

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

Checked by : ______________ Date : _________________

Verified by : ______________ Date : _________________

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

12.5 Verification of Software Components
Objective : To verify the installed software components as per the SRS.
Tools Required : Not Applicable
Procedure : 1. Verify Software Name.
2. Verify Software Version
3. Verify operating system.
4. Verify software backup availability.
Acceptance Criteria : Installed software component should match with SRS.

Verification Table:

A. For Software Components

Installation Discrepancy?
S.No. Software Name Version
(Yes/No) (Y/N)
1 Adobe Reader XI 11.0.07
Microsoft Office
2 12.0.4518.1014
Enterprises 2007
3 Mozilla Firefox 62.0
4 StabilitySP2For1.2 1.0.0
5 WinRAR 5.50 5.50.0
Windows 7
6 7 2009
Professional

B. Operating system details

S.No. Window Product key/ Liecence key Discrepancy? (Y/N)

1 Windows 7

C. Software Backup Availability

S.No. Available (Yes/ No) Discrepancy? (Y/N)

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

Remarks:
______________________________________________________________________________

______________________________________________________________________________

Meet the acceptance Criteria [ ] Yes [ ] No

Checked by : ______________ Date : _________________

Verified by : ______________ Date : _________________

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

12.6 Verification of Physical and Logical Security Control
Objective : Verify the physical and logical security of Computer System.
Tools Required : Not Applicable
Procedure : 1. Verify physical Security.
2. Verify logical security of Application Window and Software
3. Verify User for Application access
Acceptance : Physical security should be maintained. Logical
Criteria  Window Login password should be available.
 Application Software should have multiple numbers of user’s role
with user name.

A. Verification Table for Physical Security:

System Security Availablility Discrepancy?

(Yes/No) (Y/ N)
PCB should be secure in control
Computer system
Panel.

B. Verification Table for Logical Security Window:

Logical security
Specified user available Discrepancy? (Y/ N)
(Yes/No)
Admin

User

C. Verification Table for Logical User Application Software:

Logical User available

Specified user (Yes/No) Discrepancy? (Y/ N)

Admin

Master

User

Remarks:

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

______________________________________________________________________________

______________________________________________________________________________

Meet the acceptance Criteria [ ] Yes [ ] No

Checked by : ______________ Date : _________________

Verified by : ______________ Date : _________________

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

12.7 Verification of Test Instruments Calibration and Traceability
Objective : To verify the test instruments traceability.
Tools Required : Not Applicable
Procedure : 1. Verify Certificate No.
2. Verify Traceability.
3. Verify Calibration Done Date.
4. Verify Calibration Due Date.
Acceptance : Test instruments should be calibrated at the execution.
Criteria

Verification Table:

Calibration Calibration Verified Discrepancy?

Certificate No. Traceability Due On (Yes/No) (Y/N)
Done On

Refer attachment No. 2

Refer attachment No. 3

Remarks:
______________________________________________________________________________

______________________________________________________________________________

Meet the acceptance Criteria [ ] Yes [ ] No

Checked by : ______________ Date : _________________

Verified by : ______________ Date : _________________

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

12.8 Verification of Power Utility
Objective : To verify the installed power utility is as per specifications.
Tools Required : Digital Multimeter
Procedure : 1. Switch ON the Power Supply.
2. Put the Multimeter in AC/DC range.
3. Record the supply voltage.
Acceptance : Measured voltage shall match with the specified voltage.
Criteria

Verification Table:
Supply Voltage Measurement:
Measured Discrepancy?
Name Specified Voltage
Voltage (Y/N)
Computer System Power Supply 230 VAC

Stability Chamber (220-240) VAC

Remarks:
______________________________________________________________________________

______________________________________________________________________________

Meet the acceptance Criteria [ ] Yes [ ] No

Checked by : ______________ Date : _________________

Verified by : ______________ Date : _________________

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

12.9 Verification of Environment Condition
Objective : To verify the environment conditions.
Tools Required : Digital Thermo Hygrometer
Procedure : 1. Switch ON the thermo hygrometer.
2. Record maximum temperature.
3. Record maximum relative humidity.
Acceptance : Test instruments should be calibrated at the execution.
Criteria

Verification Table:

Relative Measured Discrepancy?

Name Temperature
Humidity Results (Y/N)
Computer System
NMT 25 °C NA
Environmental Condition
Stability chamber NMT 25 °C NA

Remarks:
______________________________________________________________________________

______________________________________________________________________________

Meet the acceptance Criteria [ ] Yes [ ] No

Checked by : ______________ Date : _________________

Verified by : ______________ Date : _________________

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

12.10 Verification Of Communication Link Between Server To Computer System
Objective : To Verify the communication link with server to client
Tools Required : Not Applicable
Procedure : 1. Verify and record the communication link between PC to Server
2. Verify and record the communication link between PC to Printer.
Acceptance : Communication link ping with PC to server should be executed and report
Criteria should be proper.

Verification Table:

Ping Executed Discrepancy?

S.No. Source Destination
(Yes/No) (Y/N)
01 Computer system File Server
02 Computer system Printer

Remarks:
______________________________________________________________________________

______________________________________________________________________________

Meet the acceptance Criteria [ ] Yes [ ] No Refer Attachment No. [ ]

Checked by : ______________ Date : _________________

Verified by : ______________ Date : _________________

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

12.11 Verification of General System Installation
Objective : To verify the general system installation.
Tools Required : Not Applicable
Procedure : 1. Check all the test given in verification table.
2. Record the result in verification table.
Acceptance : All the test result should match with expected result.
Criteria

Verification Table:

Expected Result Discrepancy?

Description
(Yes/No) (Y/N)
Major components should be protected from
shock.
No visible physical damage should be available.
Sufficient space should be available for
maintenance.
System identification nameplate should be
available.
System should be installed with all necessary
instruments.
Earthling should be connected properly.
Power and signal cable should be separate.
Unterminated and broken wire should not be open.

Remarks:
______________________________________________________________________________

______________________________________________________________________________

Meet the acceptance Criteria [ ] Yes [ ] No

Checked by : ______________ Date : _________________

Verified by : ______________ Date : _________________

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

12.12 Verification of Standard Operating Procedure
Objective : To verify the availability of related standard operating procedure.
Tools Required : Not Applicable
Procedure : 1. Verify SOP Name.
2. Verify SOP No.
3. Verify SOP Availability.
Acceptance : Documents should be available.
Criteria

Verification Table:

Discrepancy
Availability
SOP Name SOP No. ?
(Yes/No)
(Y/N)
Stability study

Remarks:
______________________________________________________________________________

______________________________________________________________________________

Meet the acceptance Criteria [ ] Yes [ ] No

Checked by : ______________ Date : _________________

Verified by : ______________ Date : _________________

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

13. INSTALLATION QUALIFICATION TEST STATUS
The installation qualification test status is as per below mentioned table.

Status Discrepancy?
Test Description
(Pass / Fail) (Y/N)
Identification of System Details
Verification of Master Documents
Verification of Capacity Requirement
Verification of Hardware Components
Verification of Software Components
Verification of Physical and Logical Security Control
Verification of Test Instruments Calibration and Traceability
Verification of Power Utility
Verification of Environmental Condition
Verification Of Communication Link Between Server To Computer
System
Verification of General System Installation
Verification of Standard Operating Procedures

14. DISCREPANCIES HANDLING DURING COMPUTER SYSTEM QUALIFICATION

 In case of discrepancy observed during qualification, document in the defined column in each
table and document the details of the observation in the discrepancy log sheet.
 Inform to User, engineering and quality assurance about discrepancy.
 Investigate the discrepancy and ensure the possible impact.
 If discrepancy does not have potential to impact on operation as well as performance of the
system, close the discrepancy with proper justification.
 The User, engineering and QA will decide whether discrepancy is acceptable or not.
 If discrepancy is acceptable, provide conclusion and recommendation if any into respective
column.

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

15. DISCREPANCY AND CORRECTIVE ACTION FORM

Protocol Reference
Discrepancy Number

DISCREPANCY

Describe the Discrepancy

Reported by Date

CORRECTIVE ACTION

Describe corrective action taken (Attach additional sheets if necessary)

Reported by Date

DISPOSITION ACTION

Acceptable? Yes No
Discussion

Approved by Date

COMPLETION

Completed by Date

16. ABBREVIATION

Abbreviations Description

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

GMP Good Manufacturing Practices

IQ Installation Qualification
OQ Operation Qualification
QA Quality Assurance
SOP Standard Operating Procedure
NA Not Applicable
ICH International Conference of Harmonization
mA Mili Ampere
VAC Alternate Current Voltage
VDC Direct Current Voltage
RH Relative Humidity
CS Computer System
NMT Not More Than

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

17. ATTACHMENT SUMMARY

Attachment No. Description

18. INSTALLATION QUALIFICATION SUMMARY & CONCLUSION

Compiled by: Date:

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 PHARMA DEVILS
QUALITY ASSURANCE DEPARTMENT

INSTALLATION QUALIFICATION FOR COMPUTER SYSTEM

19. POST APPROVALS
The signature listed below indicates the post approval of this installation qualification. This approval is
joint responsibility of listed functional areas.

DOCUMENT DEVELOPMENT SIGN / DATE

Name : __________________
Designation : __________________

DOCUMENT REVIEW AND APPROVAL

Sign / Date : __________________
Name : __________________
Designation : __________________
Engineering

Sign / Date : __________________

Name : __________________
Designation : __________________
IT

Sign / Date : __________________

Name : __________________
Designation : __________________
Quality Assurance

DOCUMENT APPROVAL
Sign / Date : __________________
Name : __________________
Designation : __________________
Quality Assurance

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