MHRA GxP data integrity and its 4 linked instruments

UK guidance and definitions for data integrity across GxP areas, including data governance, ALCOA+, audit trails and computerised system controls.

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.

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.

The EU GMP annex on qualification and validation.

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.

• 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• 4 Apr 2018 Earlier GMP guidance withdrawn, replaced by this GxP guidance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 Jul 2021 Final version published

• ~1 Jan 2011 Revision 1 published in EudraLex Volume 4 (January 2011)
• 30 Jun 2011 Came into operation

• 1 Oct 2015 Came into operation

• 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)