Compare ICH Q9(R1) and FDA data integrity Q&A

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How they are linked

ICH Q9(R1) is the risk basis for FDA data integrity Q&A · Source Unverified link

Side by side

	ICH Q9(R1)	FDA data integrity Q&A
Authority	ICH	FDA
Legal weight	Guidance & Q&A	Guidance & Q&A
Status	Final	Final
Last verified	Not yet	Not yet
Summary	The international guideline on quality risk management. It is the basis for scaling validation effort to risk in Annex 11, Annex 22 and computer software assurance, and the 2023 revision addresses subjectivity, formality and risk-based decision-making.	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.
Lifecycle	9 Nov 2005 Original Q9 reached Step 4 18 Nov 2021 Q9(R1) released for public consultation at Step 2 18 Jan 2023 Reached Step 4 (final)	~1 Dec 2018 Final guidance published (Dec 2018)
Source	Official text Source: ICH.	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.