Compare MHRA GxP data integrity and Annex 11 (2011)

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MHRA GxP data integrity is related to Annex 11 (2011) · Source Unverified link

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	MHRA GxP data integrity	Annex 11 (2011)
Authority	MHRA	European Commission
Legal weight	Guidance & Q&A	GMP guide & annexes
Status	Final	In force
Last verified	Not yet	Not yet
Summary	UK guidance and definitions for data integrity across GxP areas, including data governance, ALCOA+, audit trails and computerised system controls.	The current EU GMP annex for computerised systems used in GMP-regulated activities. It covers risk management, validation, data, audit trails, security, electronic signatures, periodic evaluation and business continuity. It stays in force until the revised Annex 11 is published and comes into operation.
Lifecycle	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13 Mar 2015 Earlier GMP guidance updated with clarifications 9 Mar 2018 Published 4 Apr 2018 Earlier GMP guidance withdrawn, replaced by this GxP guidance	~1 Jan 2011 Revision 1 published in EudraLex Volume 4 (January 2011) 30 Jun 2011 Came into operation
Source	Official text Source: MHRA. Contains public sector information licensed under the Open Government Licence v3.0.	Official text Source: European Commission. Licensed under CC BY 4.0.

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.