Compare Part 11 scope guidance and 21 CFR Part 11

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Part 11 scope guidance interprets 21 CFR Part 11 · Source Unverified link

Side by side

	Part 11 scope guidance	21 CFR Part 11
Authority	FDA	FDA
Legal weight	Guidance & Q&A	Law & regulation
Status	Final	In force
Last verified	Not yet	Not yet
Summary	FDA guidance on how it applies Part 11. FDA says it will not enforce certain requirements on validation, audit trails, record retention and record copying, and sets criteria for legacy systems. Part 11 remains in effect, and predicate rule requirements still apply.	The US regulation setting the conditions under which FDA treats electronic records and signatures as equivalent to paper records and handwritten signatures: validation, audit trails, access controls, record protection and signature controls.
Lifecycle	5 Sep 2003 Final guidance issued	~1 Mar 1997 Final rule issued (March 1997) 20 Aug 1997 Effective
Source	Official text Source: FDA. Public domain.	Official text Source: FDA. Public domain.

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