Compare ICH Q9(R1) and MHRA GxP data integrity

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ICH Q9(R1) is the risk basis for MHRA GxP data integrity · Source Unverified link

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	ICH Q9(R1)	MHRA GxP data integrity
Authority	ICH	MHRA
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.	UK guidance and definitions for data integrity across GxP areas, including data governance, ALCOA+, audit trails and computerised system controls.
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)	23 Jan 2015 Earlier GMP data integrity definitions and guidance first published 13 Mar 2015 Earlier GMP guidance updated with clarifications 9 Mar 2018 Published 4 Apr 2018 Earlier GMP guidance withdrawn, replaced by this GxP guidance
Source	Official text Source: ICH.	Official text Source: MHRA. Contains public sector information licensed under the Open Government Licence v3.0.

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.