Compare FDA data integrity Q&A and Part 11 scope guidance

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FDA data integrity Q&A is related to Part 11 scope guidance · Source Unverified link

Side by side

	FDA data integrity Q&A	Part 11 scope guidance
Authority	FDA	FDA
Legal weight	Guidance & Q&A	Guidance & Q&A
Status	Final	Final
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.	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.
Lifecycle	~1 Dec 2018 Final guidance published (Dec 2018)	5 Sep 2003 Final guidance issued
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.