System Acceptance Report

GOOD DOCUMENTATION PRACTICE (GDocP) VSR (VALIDATION SUMMARY REPORT)
1

Hi all,

I would like to ask your opinion regarding the following:

  • If you already wrote an IQ report, OQ report and PQ report after completion of the qualification steps (or IQ/OQ/PQ combined in one System Qualification report=SQR), is it necessary to write an additional System Acceptance Report(SAR)? And if so, what is the added value of the SAR? Because management is certain that an SAR is not required as the SQR/PQR covers all.

Regards,
Vivian

2

First off, what do your procedures say? If your procedures require a SAR then an SAR should be produced.

If your procedures don’t specify, at least on the device side, I’m not aware of any such requirement. Might not be a bad way to summarize all the qualification / validation activities and assert ready for production use but I know of no such requirement (regulatory).

Can’t speak for pharma side but I’ve not heard of any such requirement.