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013 Computer Validation Change Request1

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10 views3 pages

013 Computer Validation Change Request1

Uploaded by

chanderjagdish
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOC, PDF, TXT or read online on Scribd
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Log No.

COMPUTER VALIDATION CHANGE REQUEST


Prepare Change Request
Computer System Name and version number:

System Problem/Reason for Change:

Solution/Nature of the Change:

Requested by: Printed Name & Signature: Date:

Solution Impact Analysis


Review of 12 Basic Requirements:
Review existing validation documentation for each of the Standard Requirements and assess the
impact on each by this change request. If there is no impact, state "None" or "No impact as a result
of this change."
1. Computer Validation Plan
Intent: To ensure that the required computer validation activities are properly planned,
performed, and documented.
Impact:

2. System Documentation
Intent: To ensure that documentation exists that describes what the system does and how to use
the system. System documentation includes technical support documentation.
Impact:

3. Electronic Records and Electronic Signatures


Intent: To ensure that electronic records are accurate, reliable, and trustworthy. To ensure that
electronic signatures are authentic, reliable, trustworthy, and legally equivalent to handwritten
signatures (irrevocable).
Impact:

4. Vendor Evaluation Report


Intent: To ensure that the supplier produces a quality product, and to obtain information to
plan computer validation activities.
Impact:

5. Testing
Intent: To establish documented evidence that the computer platform and application software
were properly installed and tested, and that the computer system produces reliable,
predictable, and reproducible results.
Impact:

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6. Training
Intent: To ensure that users of the computer system are properly trained
Impact:

7. Security
Intent: To control access to the computer system.
Impact:

8. Business Continuity Plan


Intent: To ensure acceptable operation of the computer system during and after any
disruptions.
Impact:

9. Change Control
Intent: To ensure that all changes to the validated computer system are controlled.
Impact:

10. Periodic Review


Intent: To ensure that the computer system remains validated
Impact:

11. Validation Documentation


Intent: To provide the business area with reliable, organized documentation to support and
maintain an acceptable level of compliance following validation.
Impact:

12. Computer Validation Report


Intent: To ensure that the results of validation activities are documented, including deviations
from the Computer Validation Plan, and a conclusion as to whether the system can be released
for it’s intended use.
Impact:

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Approve / Deny Change
Accept Change: ___
Deny Change: ___ Reason for denial:

System Owner (or designee) or the System Administrator/IT Responsible

Signature Initials Date


[Typed/Printed Name and Role]

Accept Change: ___


Deny Change ___ Reason for denial:

Quality Assurance (If required by the business area.)

Signature Initials Date


[Typed/Printed Name]

Implement Change
Special Instructions:
[If applicable, address if there will be system down time to implement this change and/or if specific
business areas will be (adversely) affected by this change. If there are no special instructions, state
"None".]

Change tested by: [System Owner (or designee) or the System Administrator/IT Responsible if
appropriate]

Signature Initials Date


[Typed/Printed Name]

Approved for Deployment to Production: [System Owner or designee]

Signature Initials Date


[Typed/Printed Name]

Production Change Implemented by: [System Administrator/IT Responsible]

Signature Initials Date


[Typed/Printed Name]

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