Checklist for RA and QA Review of DVT (design verification test) for Software

S

Silvertabb

#1
Hi,
Is there a checklist that QA and RA people can use the review and approval of Software V&V Test Protocols, DVT reports for medical device? If the checklist is presented for separately for each discipline (i.e. RA and QA), it would very much be appreciated.

thanks
 
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yodon

Staff member
Super Moderator
#2
I've never used one and I've never heard of one - especially not for RA. It got me thinking, though, what I look for.

From a technical perspective:
* requirements coverage of tests (are all requirements mapped to tests)
* test coverage of requirements (do the tests 'fully consume' the requirements)
* is there objective evidence that the expected results are met
* was the equipment used (PCs, etc.) recorded
* was the software under configuration control and properly identified in the test

From a process perspective:
* was everything performed in accordance with any parent process doc (e.g., a validation plan and/or validation master plan)
* are any changes to the expected results properly controlled (i.e., did the tester just change the expected results to match actual results or was a controlled process followed)
* were other changes to the protocol made per a controlled process
* were the testers properly trained / experienced to execute the test (and assess the results)

From a GDP perspective:
* is all data captured in accordance with GDP (permanent ink, changes properly annotated, etc.)
* are all attachments properly linked
* is the tester properly identified and associated with all recorded information
* is there anything that would make me question the veracity of the data / results

This was just a quick list off the top of my head. Maybe others can add to it (if there aren't any checklists provided).
 
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