Did You Know...

That 21 CFR Part 11 has a retention requirement for audit trail documentation?

 

21 CFR Part 11.10 (e) requires that audit trail documentation should be retained for a period at least as long as that required for the subject electronic records and it should be available for FDA review and copying.

Read more about Part 11 and audit trail:

White Paper:
21 CFR Part 11 Industry Overview - Are You Ready for an FDA inspection?

White Paper:
21 CFR Part 11 System Validation - Risk Management Plan



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