Compare FDA electronic systems Q&A and 21 CFR Part 11

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FDA electronic systems Q&A interprets 21 CFR Part 11 · Source Unverified link

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	FDA electronic systems Q&A	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 recommendations for sponsors, clinical investigators, review boards and contract research organisations on using electronic systems, records and signatures in clinical investigations, and when FDA treats them as equivalent to paper records and handwritten signatures.	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	1 Oct 2024 Final guidance issued (October 2024)	~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.

These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.