Compare FDA data integrity Q&A and 21 CFR Part 11

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How they are linked

FDA data integrity Q&A is related to 21 CFR Part 11 · Source Unverified link

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	FDA data integrity 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's question-and-answer guidance on data integrity in drug manufacturing: ALCOA, audit trail review, access controls, shared logins and when electronic data are CGMP records.	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 Dec 2018 Final guidance published (Dec 2018)	~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.