Computer System Validation
Operational
Qualification Protocol
System Name:
Location:
Operational Qualification Protocol
for the
XXX
Page 1 of 12
Document Number:
Computer System Validation
Page 2 of 12
Operational
Qualification Protocol
System Name:
Document Number:
Location:
Document Revision History
Revision
Date
Author / Company
001
Description of Revision Changes
Initial Version
Table of Contents
1. PURPOSE/SCOPE ............................................................................................................... 3
2. DESCRIPTION...................................................................................................................... 3
3. REFERENCES...................................................................................................................... 3
3.1
DEFINITIONS .................................................................................................................. 3
4. RESPONSIBILITIES ............................................................................................................. 3
5. EXECUTION MATERIALS AND EQUIPMENT ..................................................................... 3
6. EXECUTION INSTRUCTIONS .............................................................................................. 3
7. PROTOCOL DEVIATIONS RESOLUTION ........................................................................... 3
7.1
SIGNATURE RECORD ...................................................................................................... 4
8. OPERATIONAL QUALIFICATION ....................................................................................... 5
8.1
TECHNICAL REQUIREMENTS TESTING .............................................................................. 6
8.2
USER FUNCTIONAL REQUIREMENTS TESTING ................................................................... 8
8.3
ELECTRONIC RECORDS / COMPLIANCE REQUIREMENTS TESTING .................................... 10
9. APPROVALS ...................................................................................................................... 12
Computer System Validation
Operational
Qualification Protocol
System Name:
1.
Page 3 of 12
Document Number:
Location:
Purpose/Scope
This protocol covers the Operational Qualification for the XXX. Describe any specific
functions of the system that are to be tested i.e. workflow.
2.
Description
See Validation Plan for details (If a Validation Plan was written otherwise, reference an
appropriate document with the system description or include it here.
3.
References
Supporting Documentation (All validation documents written that are associated with the system)
Document ID
3.1
Definitions
Term
4.
Title
Definition
Responsibilities
It is the responsibility of XXX to execute this protocol and XXX, XXX to approve the
executed results.
5.
Execution Materials And Equipment
List any items that may be required to complete execution i.e. temperature/humidity
gauge.
6.
Execution Instructions
Recording of data or other required information in any test document must be done pee,
Good Documentation Practices. Blue or Black ink must be used (no pencil). If an error
is made in the documentation, use one line to line out the error and write in the correct
information along with a reason for the change and initial and date the correction.
7.
Protocol Deviations Resolution
All protocol deviations must be documented using VAL008_01.
Computer System Validation
Page 4 of 12
Operational
Qualification Protocol
System Name:
7.1
Document Number:
Location:
Signature Record
Printed Name
Signature
Initials
Date
Computer System Validation
Operational
Qualification Protocol
System #:
Server:
8.
Page 5 of 12
Document Number:
Location:
Operational Qualification
Test Purpose:
The purpose of this test is to verify the operation of the XXX
Test Method:
Record the results in the appropriate row of the test table. Where possible, screenshots or other documented evidence may
be included as supporting evidence and attached to the test protocol and marked with the appropriate protocol number,
attachment page number (as x of y), test page number, test step number references, and initials and date.
Acceptance Criteria:
All Expected Results must match the Actual Results for each test step.
Computer System Validation
Page 6 of 12
Installation
Qualification Protocol
Document Number:
System Name:
Location:
8.1
Technical Requirements Testing
Step
1.
Test Step
Expected Result
Actual Result
Pass /
Fail
Reference
Initial and
Date
Computer System Validation
Page 7 of 12
Installation
Qualification Protocol
Document Number:
System Name:
Location:
Technical Requirements Testing
Comments/Additional Information:
8.1
Conclusion:
Did the Actual Results for each test step match the Expected Results listed?
Yes
Completed By:
Date:
Reviewed By:
Date:
No
Computer System Validation
Page 8 of 12
Installation
Qualification Protocol
Document Number:
System Name:
Location:
8.2
User Functional Requirements Testing
Step
1.
Test Step
Expected Result
Actual Result
Pass /
Fail
Reference
Date and
Initial
Computer System Validation
Page 9 of 12
Installation
Qualification Protocol
Document Number:
System Name:
Location:
8.2
User Functional Requirements Testing
Comments/Additional Information:
Conclusion:
Did the Actual Results for each test step match the Expected Results listed?
Yes
Completed By:
Date:
Reviewed By:
Date:
No
Computer System Validation
Page 10 of 12
Installation
Qualification Protocol
Document Number:
System Name:
Location:
8.3
Electronic Records / Compliance Requirements Testing
Step
1.
Test Step
Expected Result
Actual Result
Pass / Fail
Reference
Date and
Initial
Computer System Validation
Page 11 of 12
Installation
Qualification Protocol
Document Number:
System Name:
Location:
8.3
Electronic Records / Compliance Requirements Testing
Comments/Additional Information:
Conclusion:
Did the Actual Results for each test step match the Expected Results listed?
Yes
Completed By:
Date:
Reviewed By:
Date:
No
Computer System Validation
Installation
Qualification Protocol
System Name:
Location:
9.
Approvals
Page 12 of 12
Document Number: