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IT DEPARTMENT

OPERATIONAL & PERFORMANCE QUALIFICATION FOR COMPUTER SYSTEM

Name of Item: Computer System Protocol No.:.........................

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Instrument Name Computer System

System ID. ...................

System Used For High Pressure Liquid Chromatography

Make Waters

HPLC ID. ..................

Application Software Type Chromatographic Non Chromatographic 

Application Software Empower

Software Version 3.0

Make Waters

System Type New System  Existing system 

Location Instrument Room

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1.0 DOCUMENT PRE-APPROVAL:

Department Name Designation Signature Date

Prepared by: M/s. ..............

ENGINEERING

Reviewed by: M/s. ..............

QUALITY ASSURANCE

Reviewed by: M/s. ..............

ENGINEERING

Reviewed by: M/s. ..............

IT DEPARTMENT

Reviewed by: M/s. ..............

QUALITY CONTROL

Approved by: M/s. .............

QUALITY ASSURANCE
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2.0 TABLE OF CONTENTS:

1.0 DOCUMENT PRE-APPROVAL:......................................................................................... 2

2.0 TABLE OF CONTENTS: ..................................................................................................... 3
3.0 PURPOSE: ............................................................................................................................. 4
4.0 SCOPE: .................................................................................................................................. 4
5.0 DESCRIPTION: .................................................................................................................... 4
6.0 REFERENCES: ..................................................................................................................... 4
7.0 RESPONSIBILITIES: ........................................................................................................... 5
8.0 DEFINITIONS: ..................................................................................................................... 5
9.0 EXECUTION INSTRUCTIONS: ........................................................................................ 7
10.0 OPERATIONAL AND PERFORMANCE QUALIFICATION: ......................................... 8
11.0 RECORDED VERIFICATIONS DURING OPERATIONAL AND PERFORMANCE
QUALIFICATION: ....................................................................................................................... 10
14.0 VERIFICATION OF STANDARD OPERATING PROCEDURES AND POLICY: ...... 29
15.0 DISCREPANCY REPORT: ................................................................................................ 32
16.0 ACCEPTANCE CRITERIA: .............................................................................................. 36
17.0 SUMMARY: ........................................................................................................................ 36
18.0 CONCLUSION: ................................................................................................................... 36
19.0 ABBREVIATIONS: ............................................................................................................ 37
20.0 LIST OF SUPPORTING DOCUMENTS:.......................................................................... 39
21.0 DOCUMENT POST APPROVAL:..................................................................................... 40
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3.0 PURPOSE:
This document covers the Operational and Performance Qualification for the Computer System
and Software for HPLC installed. The purpose of this document is to properly document and
evidence that the Instrument installation has been done in accordance with the given
specifications and is operating as desired.

4.0 SCOPE:
Scope of this document is to record and report the execution of OQ an PQ (Collectively OPQ) of
the computer system and Software as per there operations in Quality Control, Production and
Documentation.

5.0 DESCRIPTION:
The Operational and Performance Qualification (OPQ) execution; verifies that the Instrument,
and its ancillary systems or Sub-Systems and Installed Application Software have been operating
and Performing in accordance with the Requirements and specifications. It further details a list of
all the cGMP requirements that are applicable to this particular Operational and Performance
qualification. These requirements must be all satisfied before the OPQ can be completed
The Operational and Performance qualification (OPQ) is a collection of test cases used to verify
the proper functioning status of a system. OPQ is majorly performed in case of:

a. New Installation (When there is fresh installation of Hardware/Software or both)

b. Existing system (When Hardware/ Software is already Installed and running properly)
c. Change in Location of the system (When Hardware is shifted from initially installed
location to new location according to approved change control procedure.

This Document covers the reports of OPQ for Existing System.

6.0 REFERENCES:
a. Good Automated Manufacturing Practices (GAMP)-5 Guidelines (This guideline is the
latest, upto date thinking in the approach to validation of GxP computerized system.
b. EU GMP Annexure-11( Annex. -11 is part of European GMP Guidelines and defines the
terms of references for computerized systems used by the organizations in the
pharmaceutical industry.
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c. 21 CFR Part 11 (Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal
Regulations that establishes the United States Food and Drug Administration (FDA)
regulations on electronic records and electronic signatures (ERSE).
d. Who Guidelines on Validation- Appendix 5 Validation of Computerized Systems.

7.0 RESPONSIBILITIES:
Department Responsibility
Engineering and Review of OPQ Document. Verification of OPQ test. Provide support
IT required during operational qualification.

Quality Assurance Review and approval of OPQ document. Verification of OPQ tests.
Consultant Prepare OPQ Document and Performing OQ tests as per OPQ Document.

8.0 DEFINITIONS:

Term Definition
Actual Result What a system does when a particular action is performed
Deliverable A tangible or intangible object produced as a result of project execution, as part of an
obligation. In validation projects, deliverables are usually documents.
Deviation When a system does not act as expected
End-User A person who uses the validated system
Expected Result What a system should do when a particular action is performed
Installation Establishing confidence that process Instrument and ancillary systems are compliant with
appropriate codes and approved design intentions, and that manufacturer
Qualification recommendations are suitably considered. In practice, the installation qualification is
the executed test protocol documenting that a system has the necessary prerequisite
conditions to function as expected.
Operational Establishing confidence that process Instrument and sub- systems are capable of
consistently operating within stated limits and tolerances. In practice, the operational
Qualification qualification is the executed test protocol documenting that a system meets the defined
functional requirements, or that the system does what it’s supposed to do.
Performance Establishing confidence that the process Instrument and sub- systems are capable of
Qualification consistently performing well within the specific requirements. In practice performance
qualification is the executed test protocol documenting that system meets the defined
performance requirements, or that the system perform as it supposed to do.
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Term Definition
Protocol A collection of Test Cases, used to document the testing of a system.
Qualification A testing protocol which designates that a system meets a particular collection of
requirements. An Installation Qualification ensures that a system has been properly
installed. An Operational Qualification demonstrates that a system functions as expected
in a controlled environment. A Performance Qualification verifies that a system works
under real-life conditions.

Quality Assurance Members of the organization who are tasked with ensuring the quality of materials
produced at that organization. GxP organizations are required to have robust and
independent Quality Assurance operations. Depending on the organization, this group
may be titled Quality Control or Quality Organization; other organizations have multiple
groups dedicated to quality with their own distinct missions.
Requirement Something a system must be able to do
Retrospective Validation of an existing system. Retrospective validations are usually performed in
response to a new need for a system to be compliant or an identified gap in GxP
Validation compliance.
Specification A document outlining the requirements for a system. Specifications are usually sub-
divided into User Requirements Specifications, Functional Requirements, and Design
Specifications.
System Object or process undergoing validation. In these pages, system is intended to be a generic
term, meaning computer system, Instrument, method or process to be validated.

System Owner The individual who is ultimately responsible for a system.

Test Case A documented procedure, used to test that a system meets a particular requirement or
collection of requirements.
Test Plan A general testing methodology established to ensure that a system meets requirements. A
Test Plan can also refer to the collection of protocols or qualifications used to test and
document that a system meets requirements.
Test Step An individual line of a Test Case. Each Test Step should include instructions, an expected
result, and an actual result.
Traceability The ability to ensure that requirements outlined in the specifications have been tested.
This is usually recorded in a Requirements Traceability Matrix.
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Term Definition
Validation A documented process, testing a system to demonstrate and ensure its accuracy,
reliability, and consistent intended performance.
Validation A collection of documents produced during a validation project.
Package

9.0 EXECUTION INSTRUCTIONS:

Completion of OPQ will governed by the following procedures:
9.1 Prior to starting any test case, the individual(s) involved must be trained on the particular test
case(s) and any other procedure required in executing the test case(s).
9.2 Within the exception of the protocol approvers, each person who performs or reviews any section
of the tests within this document must complete/verify all information required.
9.3 All tests that are require the person executing the protocol make comparison, Calculation or a
Judgment of satisfactory completion, will Include “Pass” or “Fail” column. This section will
require the person executing the protocol to enter a disposition of each test or test step ass
appropriate.
9.4 If during the execution of the protocol Deviation occur it shall be documented and appropriate
corrective action shall be taken as per the predefined procedure for handling of Deviations.
9.5 Any comments regarding test Case(s) shall be recorded on the test sheet under the comments
section. If there is no comment, the comments shall be marked as NA for “Not Applicable”.
9.6 The “Reviewed by” signature line will be signed by an independent Reviewer who has read and
agrees the respective test case execution and conclusion.
9.7 All protocol entries will be completed using indelible Blue or Black Ink Pen.
9.8 General acceptance criteria:
If all the test case meet the acceptance criteria, the test case is successful and it passes. If a test
case does not meet expected results, a deviation document will be created, an investigation will be
conducted to determine cause of failure, and after the proper deviation form and corrective
action(s) are completed, the test may be repeated if required. The Re-Test data must also be
included as an attachment to the referenced Deviation form. If the corrective actions and re-tests
fail then the protocol approvers may consider and Qualification effort as failed and will determine
other actions necessary to address the impact of the failure; e.g., immediate halt on the use of the
Instrument, additional characterization and re-design, further investigation of root cause(s) etc.
For closure of the protocol, all the test cases must be successfully completed and all deviations
must be addressed and resolved. Once these steps have been accomplished, the OPQ will be
considered completed and closed.
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10.0 OPERATIONAL AND PERFORMANCE QUALIFICATION:

a. Test Purpose: The purpose of this test is to verify operation and Performance of the computer system and Installed
Application Software.
b. Test Method: Record the results in the appropriate row of the test table. Where possible, screen shots and other
documented evidence may be included as supporting evidence and attached to the test protocol and marked with the
appropriate protocol number.
c. Acceptance Criteria: All the expected results must match the actual results for each test step.

10.1 Test Table:

S.No. Test Step Description Expected Results Actual Results Pass/Fail

1. OPQ pre requisites All OPQ Pre-Requisites are Computer system with properly
Verification completed successfully and implemented Desktop and Security
fully approved. policy for Computer system and
Installed Application Software
shall be available.
2. Users Training All personnel operating the Only properly trained and
Verification system and Installed authorized personnel shall be
Application Software shall allowed to operate System and
meet training requirements. Application Software.
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S.No. Test Step Description Expected Results Actual Results Pass/Fail

3. Process Procedures Site procedures must be Different procedures for training
Compliance Verification approved and adequate to and operation of system shall be
allow trained Users and/or Available, Approved and
personnel to consistently Implemented.
perform the operations in
accordance with the specified
procedures.

4. Worst case challenge test System shall have properly Procedures to handle worst case
of Disaster Management defined and operating as shall be available in place.
required to handle Worst
cases.

Acceptance criteria:
 The Documents listed in the test result sheet should be available, readable and complete.

Actual result meets acceptance criteria:

 (Yes/No) __________

Tests performed By: Date Sign

Consultant

Tests Reviewed By: Date Sign

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Comments / Deviations:

11.0 RECORDED VERIFICATIONS DURING OPERATIONAL AND PERFORMANCE QUALIFICATION:

a. Test Procedure: The purpose of this section of report is to record data in the test table of OPQ and is intended to:
 Computer System Qualification:
 Computer System Bootup Check
 Date and Time Check
 Hard Disk Check
 Print Drive Check
 Network Connection Test
 Software Version Check
 Program alteration Check
 Software Qualification
 Application Software Configuration
 User Authentication and Access Control Check
 Password log management
 Number of password check
 Failed login detection
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 User lockout function

 Failed login log check
 User access right control
 Password Expiry availability check

b. Test Method: Record the results in appropriate row of the test table. Where possible, Screen shots or other documented
evidence may recorded as the supporting evidence and attached to this document with appropriate document number and
other sequential information.
c. Acceptance criteria: Expected results must match the actual results for each test step.
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SOFTWARE CONFIGURATION FOR EMPOWER SOFTWARE

13.1 TEST DATA TABLE TO RECORD VERIFICATIONS DURING OPERATIONAL AND PERFORMANCE
QUALIFICATION:
13.1.1 COMPUTER SYSTEM QUALIFICATION (Work Station software) Operating System
S.No. Test Step Description Expected Results Actual Results Pass/Fail
1. Verification of Startup Start main supply System shall start and
and Shutdown procedure Press the power button of Laptop. shutdown Normally as
of computer system. Logon screen will appear. per the defined
Enter correct Username and Password procedure.
Desktop screen will Appear
Close all running programs No adverse alarms/ or
Click Start Icon on the screen and command messages shall be
for shutdown. indicated on the
Ensure all Lights are off. Desktop Screen.

Power off Monitor

Switch off from the main supply
2. Verification of Operating To login to the computer enter incorrect System Should not
System security. login ID and password allow Login without
correct user ID and
Password. Error
Message shall be
displayed.
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S.No. Test Step Description Expected Results Actual Results Pass/Fail

To login to computer enter Correct login ID System shall allow
and password. login.
3. Verification of Operating Login with existing User Account and Error Message shall be
System Password policy change the password with less than defined displayed on the
Challenge test. password length. screen.

Login with existing User Account and Error Message shall be

change the password with More than defined displayed on the
password length. (Without Numbers) screen.

Login with existing User Account and Error Message shall be

change the password with More than defined displayed on the
password length. (Without special screen.
Character)
Login with existing User Account and Error Message shall be
change the password with More than defined displayed on the
password length. (Without Alphabets) screen.

Try to login with incorrect username and Error Message shall be

password for more than account lockout displayed on the
threshold. screen. Access shall be
locked.
Login with username and password and User shall signed out
leave the system on standby for more than automatically after
Defined Time Defined Lockout
Time.
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S.No. Test Step Description Expected Results Actual Results Pass/Fail

Login with existing user account and change Error Message shall be
the password same as previous password. displayed on the
screen.

Login with existing user account and change Error Message shall be
the password same as username. displayed on the
screen.

4. Verification of Desktop SOP for Desktop policy shall be available SOP for desktop
Policy and implemented Policy shall be
available and
Implemented.
Access to USB storage device shall not be Access shall not be
available to user. granted and error
message shall be
displayed on screen.
Task Manager Shall Not be Accessible to Task Manager shall
user through Ctrl+Alt+Delete key. not be available.

Task Manager shall not be accessible to user Task Manager shall

from task bar. not be available
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S.No. Test Step Description Expected Results Actual Results Pass/Fail

User Shall Not be able to open Control Control Penal Shall not
panel. be assessable. To user.

Security policies shell not be accessible to Shall not be assessable

User. to user.

CMD shall not be accessible to user. Error Message shall be

displayed on screen.

Registry Editing shall be disabled to user. Error Message shall be

displayed on screen.

Event logs for application shall be enabled. Event logs for

application Shall be
available.

Event logs for security shall be enabled. Event logs for Security
Shall be available.
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S.No. Test Step Description Expected Results Actual Results Pass/Fail

Event log for system shall be enabled. Event logs for System
Shall be available.

Map network drive shall be disabled. Map Network Drive

feature shall be
disabled.

There should be no access to Excel, MS Limited Access

Word, or Adobe editor in system attached to granted for
analysis Instrument, But Adobe Viewer Can documentation purpose
be available for system used for document
Purpose.
5. Verification of Date and Login with user Id and password and try to User shall not change
Time check. change set date and time of the computer Date and Time in
system. system.
6. Verification of Hard Login with user ID and try to change Or Error message shall
disk. delete Name, disk Space and Partition of appear access is
system. denied.
7. Verification of Print Print something using installed print drive Printer is not installed.
drive. and verify that same print is printed by the
Instrument.
8. Network Connection System shall be connected to LAN of System shall be
Test Authorized server. connected to LAN if
required so.
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S.No. Test Step Description Expected Results Actual Results Pass/Fail

9. Software version Check All latest and updated and licensed Software As per requirement
shall be used. latest software shall be
available
10. Verification of Network System shall be connected to authorize Only Authorized
connection. Network only. network is allowed.
11. Verification Of Desktop SOP for desktop policy shell be available SOP shall be available
Policy. and implemented. and implemented.

12. Verification of Antivirus Check status of all the installed software. Latest, updated and
Installed. licensed Software shall
be used.

13. Verification of Access to Login with user ID and password and insert Access shall be denied.
USB storage device. USB storage device.

14. Program alteration test. Login with user ID and password and try to Access to drive having
alter predefined settings in drives and OS installed is it shall
programs of operating system. not be available to
user.
15. User Authentication and Local computer policy/Computer Only Administrator
access control check configuration /windows settings/Security shall have access to
Settings/Local Policies/User rights Local computer policy
assignment. and other information.
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S.No. Test Step Description Expected Results Actual Results Pass/Fail

16. Password log Password policy shall be available to Password Policy shall
management Function manage system security. be implemented.
check
17. Password Complexity Password complexity shall be enabled in Password complexity
Check System policy. shall be enabled.

18. Maximum Password Age Maximum Age for a password after which it Maximum Password
will be expired shall be defined. age shall be defined.

19. Minimum Password Minimum password length shall be defined Minimum Password
Length below which new or change password is not age shall be
accepted. configured.
20. Failed login detection Policy for Failed Login detection shall be Policy shall be
Check enabled in system policy. enabled.

21. User lockout function Policy for user Lockout after certain failed Policy shall be enabled
test. login attempts shall be enabled.
22. Account Should Lockout It shall be defined that after how many failed Policy shall be enabled
after Defined Invalid login attempts Account shall be locked out.
login Attempts.
23. User access rights check Access rights for user shall be configured. Rights shall be
configured.
24. Password expiry alarm Password expiry period shall be defined. Password expiry
test policy shall be defined.
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S.No. Test Step Description Expected Results Actual Results Pass/Fail

25. System policy function System User Desktop policy shall be Local system policy
check available. shall be enabled.

26. The System should Provision to create new user should be System Administrator
provide the facility to available. shall be allowed to
create new Users. create New User as per
requirement.
27. The system should not Correct Combination of User ID and Login access shall not
allow user to Login Password should be required to login. be granted without
without correct Correct combination of
combination of User ID. User ID and Password.
And Password.
28. The System should System Administrator should be allowed to Administrator should
allow Administrator to reset user account. be allowed to reset
reset user Account user account.
29. The system should Facility to Delete/Disable/Remove user Administrator should
provide facility to Delete account should be available. have right to
Disable/Remove user Delete/Disable or
Accounts. remove user account.
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13.1.2 COMPUTER SYSTEM QUALIFICATION (System Application Software):

S.No. Test Step Description Expected Results Actual Results Pass/Fail

1. Name of Software Empower developed by Waters Empower developed Empower
by Waters
2. Software Version 3.0 3.0 3.0
SOFTWARE CONFIGURATION
System Security
3. Unique User Account Unique user Account Name should be Each user shall have
Name available for Each User unique user ID.
4. Unique User Password Unique user Password Should be provided to Each user should have
each user. unique user password.
5. Password Expiry Password Expiry period should be defined Password expiry
for users. duration shall be
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S.No. Test Step Description Expected Results Actual Results Pass/Fail

implemented as per
defined policy
6. Limited Entry Attempts Limited entry attempts should be enforced. User should be
allowed only limited
login attempts after
which account should
lockout itself as per the
defined policy/
7. Minimum Password Minimum Password length for login shall be System should not
length Implemented. except change
password below
defined Password
length.
8. New User creation Software should allow should provide the Facility should be
facility to New User Creation. available.
9. Duplicate User Account Software should not allow duplicate user Should not be allowed.
account.
10. Modification of User Software should have facility to Modify Facility Should be
account User Account available
11. Login without Correct Software should not allow user to Login Login should not be
combination of user ID without Correct Combination of User ID and allowed to without
and Password. Password. correct Combination of
User ID and Password.
12. Reset User Account Software should allow Administrator to Should Be allowed.
Reset User Password.
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S.No. Test Step Description Expected Results Actual Results Pass/Fail

13. Delete/Disable or Software should allow Administrator to Should be allowed
Remove User Accounts. Delete/ Disable or Remove User Accounts.
14. Software Lockout Software should lockout after Pre defined Provision should ne
Time available.
15. Software Configuration User Management and for acquiring, User Management and
and usage processing, reporting, and managing for acquiring,
chromatographic information. processing, reporting,
and managing
chromatographic
information.
16. Software GxP Status Shall comply with Software Category 4. Software Category 4
17. User Authentication and User Access Levels are available Clearly Defined
Access Control Check Access levels shall be
available.

18. Password Log Check Password Policy, Expiry, and Well implemented
Management complexity. Password policy,
Expiry and complexity
shall be available.
19. Number of Password System Should Not Accept Last Three Policy shall be
Check. Passwords during Password Check. implemented.
20. Failed Login detection Try to access Software with Wrong User ID Error Message shall be
and Password. generated for failed
login.
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S.No. Test Step Description Expected Results Actual Results Pass/Fail

21. User Lockout Function In case system is idle for certain period as System shall Lockout
defined in Policy. System should Lockout automatically if Idle.
automatically and Password shall be
required to login into the system Again.
22. Failed Login Log Check System Shall keep Log for all the Failed Log for Failed Login
Login Attempts. Attempts shall be
Available in System.

USER ROLE / AUTHORIZATION CONTROL

23. User Management Application Software must support at least User roles as per
the following user roles but not limited to: requirement should be
 Administrator available.
 Reviewer
 Analyst

24. User Access Rights Well defined assess Rights shall be User is not allowed
Control. available. And user is not allowed to assess access rights of other
Rights of admin level. Higher Levels.
TECHNICAL REQUIREMENTS

Communication/ Power Failure and Recovery

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S.No. Test Step Description Expected Results Actual Results Pass/Fail

25. Communication Failure Communication failure indication Should be Failure Indication
displayed in the screen. Shall be displayed.

After re-establishment of communication, No Change should be

the set parameters/ Process activity .Should observed.
remain unchanged or No Any Error Message
shall be displayed.
26. Power Failure I case of Power failure, the system should System Shall starts
start normally after power resume. Normally.

In case of power failure, Method /Sequence

Method /Sequence
should not be affected. should remain
unaffected.
OPERATIONAL / FUNCTIONAL REQUIREMENTS

Operational Requirements
27. Software Control Software should be controlled by User Name User Name and
and Password. Password for user
should be available.
28. Sample details The software should allow user to fill Should be allowed.
sample details.
29. View Analysis The software should allow user to view Should be allowed.
ongoing analysis.
30. View report of generated The software should allow user to view Should be allowed.
Data generated data during analysis.
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S.No. Test Step Description Expected Results Actual Results Pass/Fail

31. Print Report The software should allow user to print Should be allowed.
report on pre-defined format.
32. Alteration of Generated The Software should not allow alteration in Should not be
data and report. Data and report generated. allowed.
Functional Requirements

33. Access to Existing The Software should allow authorized

Record personnel to access existing records.
34. Electronic Records Provision of electronic records shall be E-Records shall be
available available and user
User should not be allowed to delete should not be able to
E-Records. delete it.
35. Electronic Signature Provision of electronic Signature shall be E-Signature shall be
available available
36. Edit Report Templet The software should not allow Unauthorized Should not Allow.
user’s to Edit existing Report Templet.
Report Output Requirements

37. Printed Report Printed report from software should Match Should Match.
with displayed in Application Software.
38. Report Parameters The Report must have following parameters Should be as per
but not limited to: requirement.
 Test Information
 Sample Information
 Result Data
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S.No. Test Step Description Expected Results Actual Results Pass/Fail

39. Report Alteration The Software should generate Data/Report Should not be altered.
in unalterable way.
40. Report Format The report should be printable in Pre- Should Comply
Defined format.
41. Data availability for The software should be capable of producing Should Comply
Inspection accurate and complete copies of electronic
records in both human readable and
electronic form for Inspection review and
copy.

DATA REQUIREMENTS

Audit Trail Requirement

42. Software Audit Trail System Audit trail must track the creation, Should Comply
modification, and deletion of records
Including the Time, Date, User, and reason
for the change. E.G.,
 User logon / Logout
 Change in parameters
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S.No. Test Step Description Expected Results Actual Results Pass/Fail

 Incorrect Login Attempts
 Change in user authorization of
application software.
43. Export of Audit Trail The audit trail must be viewable and can be Should Comply
exported in protected non editable format.
44. Modification and The audit Trail must be protected from Should Comply
Deletion Intentional and accidental Modification.
It Must not be possible to modify or delete
Audit Reports/ Audit trails.
45. Printing Audit Trail Generated audit trail should be Printable. Should Comply
Prints should be in Human readable format.
Data Backup Requirement

46. Data Backup All GxP Critical data should be backup as Should Comply
per defined procedure.
Data Backup Mechanism should be
available.
47. Backup Schedule Schedule for Data Backup should be Should Comply
available.
Data Restoration

48. Mechanism Data restoration mechanism shall be Shall Be Available

available.
49. Policy Data restoration policy shall be available Shall Be Available
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Note: Detailed Validation of Empower 3 software was done by the developer at the time of installation copy of same is attached as
annexure herewith.
Acceptance criteria:
 The Documents listed in the test result sheet should be available, readable and complete.
Actual result meets acceptance criteria:
 (Yes/No) __________

Tests performed By: Date Sign

Tests Reviewed By: Date Sign

Comments / Deviations:

14.0 VERIFICATION OF STANDARD OPERATING PROCEDURES AND POLICY:

PURPOSE:
The purpose of this section is to verify the availability of all required Standard Operating procedures (SOPs) for the computer
systems.
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PROCEDURE:
 Verify that all the documents required for the computer system are found available.
 Verify availability of SOP for Computer system operation.
 Verify availability of SOP for Change Control.
 Verify availability of SOP for Access Control.
 Verify availability of SOP for User Creation /Deletion/Role and Authorization.
 Verify availability of SOP for Preventive Maintenance.
 Verify availability of SOP for Data Backup and Restoration.
 Verify availability of SOP for Disaster recovery Plan and Policy.
 Verify availability of SOP for Group Desktop and Security Policy.
 Verify SOP For Training and Evaluation.
ACCEPTANCE CRITERIA:
All the required SOPs shall be Available, Reviewed, Approved and Implemented.

14.1 VERIFICATION OF STANDARD OPERATING PROCEDURES AND DATA TABLE:

S.No. SOP Name SOP No. Meet Acceptance Initial & Date
Criteria (Yes/No)
1. SOP for Computer System Operation
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2. SOP for Change Control

3. SOP for Access Control
4. SOP for User Creation/Deletion/ Role and
Authorization.
5. SOP for Preventive Maintenance
6. SOP for Data Backup and Restoration
7. SOP for Disaster recovery Plan and Policy
8. SOP for Group Desktop and Security Policy
9. SOP For Training and Evaluation

Acceptance criteria:
 The Documents listed in the test result sheet should be available, readable and complete.
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Actual result meets acceptance criteria:

 (Yes/No) __________

Tests performed By: Date Sign

Tests Reviewed By: Date Sign

Comments / Deviations:

15.0 DISCREPANCY REPORT:

15.1 Discretion Of Deficiency and its Classification:
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S.No. Discrepancy/ Category

Deficiency

15.2 Recommended Corrective Action Plan And Person Responsible:

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S.No. Discrepancy/Deficiency Responsibility Category

Provisional approval to proceed further with ibid Corrective Action(s) for Category B deficiency:

Initiated By User Department I.T. Quality Assurance

(Sign and Date) (Sign and Date) (Sign and Date) (Sign and Date)
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15.3 Corrective Actions Taken:

Sr. No. Corrective Action Sign Date
Taken

Closure Remarks: Allowed/ Not Allowed to Proceed Further

Reviewed and Approved by Projects:
Reviewed and Approved by Quality Assurance:
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16.0 ACCEPTANCE CRITERIA:

Installation and Operational Qualification shall be considered acceptable when actual result/ observed results of all
the conditions specified in various data sheets as mentioned prior in this document matches with corresponding expected
results.

Any deviation from the acceptance criteria of the specific check point shall be reported and decision should be taken for
the rejection, replacement or rectification of the computer system.

17.0 SUMMARY:
All the installation and Operational Qualification tests for computerized system are performed as per written procedures
and protocols. The results observed during complete process are recorded and reviewed.

Observed results are found meeting acceptance criteria. During execution no discrepancies were found.

18.0 CONCLUSION:
The computer System Hardware and Operating System are tested and verified as per the guidelines described in
this document on the basis of approved protocols and other corresponding references.

The computer system stands Qualified as per the tests performed and observed results therein.
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19.0 ABBREVIATIONS:
Acronym Description
°C Degree Celsius
21 CFR 11 Code of Federal Regulations, Title 21, Part 11 contains regulations with regards to electronic records and
signatures
AC Alternating Current
ALU Arithmetic and Logical Unit
AMD Advanced Micro Devices
API Application Programming Interface
AuthIP Authenticated Internet Protocol
AV Antivirus
BIOS Basic Input Output System
CD Compact Disc
CFR Code of Federal Regulations
CGI Common Gateway Interface
CGMP Current Good Manufacturing Practices
CMOS Complementary Metal-Oxide Semiconductor
CPU Central Processing Unit
CSV Computer System Validation
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Acronym Description
DC Direct Current
DMI Direct Media Interface
DVD Digital Versatile Disc
GAMP Good Automated Manufacturing Practices
GMP Good Manufacturing Practices
ID Identification
IQ Installation Qualification
NA Not Applicable
OPQ Operational and Performance Qualification
OS Operating System
PC Personal Computer
RAM Random Access Memory
PH Relative Humidity
SOP Standard Operating Procedure
TCP/IP Transmitted Control Protocol/ Internet Protocol
UPS Uninterrupted Power Supply
V Volts
VAC Volts Alternating Current
VDC Volts Direct Current
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20.0 LIST OF SUPPORTING DOCUMENTS:

Checked By
S.No. Description of Attachment Annexure No.
Sign/Date
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21.0 DOCUMENT POST APPROVAL:

Department Name Designation Signature Date
Prepared by: M/s. .................

ENGINEERING

Reviewed by: M/s. ..................

QUALITY ASSURANCE

Reviewed by: M/s. ...................

ENGINEERING

Reviewed by: M/s. ...................

IT DEPARTMENT

Reviewed by: M/s. .................

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QUALITY CONTROL

Approved by: M/s. ..................

QUALITY ASSURANCE