Approval of Test Protocols (steps)

COMPUTER SYSTEM VALIDATION (CSV) SOFTWARE VALIDATION DOCUMENTATION
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Does anyone know if the FDA would expect to see that our test protocols were formally approved prior to execution? Some of our groups are wanting to use a validated electronic system to enter and log test results, but that system does not have the ability to capture e-sigs. They want to just have a test plan with a summary of testing activities approved, but not the actual protocols themselves.

The only think I can find in the FDA’s General Principles of Software Validation; Final Guidance for Industry and FDA Staff issued January 11, 2002…section 5.2.6 is: “User site testing should follow a pre-defined written plan with a formal summary of testing and a record of formal acceptance.”

I’m also aware of the GAMP best practices below, but is there a true requirement to have the test steps formally approved?:
-Tests are executed according to a pre-defined and pre-approved test procedure (or protocol), which is established on the appropriate system or equipment specification.
-Tests should be based on formal documents held under version control according to Good Documentation Practice.
-Testing should not start before the test procedure has been approved.

Thank you in advance for any information you might have on this subject!

Michelle

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[quote=micboucher]Does anyone know if the FDA would expect to see that our test protocols were formally approved prior to execution? Some of our groups are wanting to use a validated electronic system to enter and log test results, but that system does not have the ability to capture e-sigs. They want to just have a test plan with a summary of testing activities approved, but not the actual protocols themselves.
[/quote]

Yes absolutely, all test scripts must be approved by everyone on your approval list.

This is a standard approach for all validation executions.

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As Graham notes, absolutely! If you need a hammer, look to 21 CFR 820.40(a):

Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance all documents established to meet the requirements of this part. The approval, including the date and signature of the individual(s) approving the document, shall be documented.

Bold font done for emphasis. I think that’s pretty clear!

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Thank you so much for the information!