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Specifically, 58.130(e) Dirk From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On Behalf Of Paula Wehmeyer Sent: Wednesday, November 25,
You might try 21 CFR Part 58 (the GLPs) for a pretty solid description. Thank you, Paula My opinions are my own and do not necessarily represent those of my
HI All- I know what Good Documentation Practices are, but can anyone point me to the predicate rules which mention these are necessary? I am noticing in my new
Awesome! Thanks for the response... I felt the same way, and when you spelled it out, it reassures me that we do have to perform in house testing, such as the
Only you know your requirements - they can only surmise what these are. You need to demonstrate that the application meets your requirements or, in the event