Compare FDA data integrity Q&A and 21 CFR Part 211

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FDA data integrity Q&A interprets 21 CFR Part 211 · Source Unverified link

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	FDA data integrity Q&A	21 CFR Part 211
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.	US CGMP rules for finished pharmaceuticals. Section 211.68 allows computers and automated equipment in manufacture if they are routinely checked under a written program. It requires controls so only authorised people change master records, checks on input and output, and a backup of data.
Lifecycle	~1 Dec 2018 Final guidance published (Dec 2018)	29 Sep 1978 Published at 43 FR 45077
Source	Official text Source: FDA. Public domain.	Official text Source: FDA. Public domain.

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