PIC/S PI 041-1 and its 1 linked instrument

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	PIC/S PI 041-1	MHRA GxP data integrity
Authority	PIC/S	MHRA
Legal weight	Guidance & Q&A	Guidance & Q&A
Status	Final	Final
Last verified	Not yet	Not yet
Summary	Inspectorate guidance on data management and integrity for paper, hybrid and electronic systems, including data governance, ALCOA+ and computerised system controls. No revision announced as of October 2026.	UK guidance and definitions for data integrity across GxP areas, including data governance, ALCOA+, audit trails and computerised system controls.
Lifecycle	1 Jul 2021 Final version published	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13 Mar 2015 Earlier GMP guidance updated with clarifications 9 Mar 2018 Published 4 Apr 2018 Earlier GMP guidance withdrawn, replaced by this GxP guidance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 Summary in our own words. See the official text from PIC/S.	Official text Source: MHRA. Contains public sector information licensed under the Open Government Licence v3.0.

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