MHRA 'GXP' Data Integrity Guidance and Definitions

MHRA · Final

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Summary

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

Dated events

1. 27 Sep 2021 MHRA Inspectorate blog: for GLP facilities the OECD advisory document on data integrity takes precedence; MHRA guidance still supplements it (guidance text itself not revised) Source for MHRA Inspectorate blog: for GLP facilities the OECD advisory document on data integrity takes precedence; MHRA guidance still supplements it (guidance text itself not revised)
2. 9 Mar 2018 Published Source for Published

Official source

Official text

Source: MHRA. Contains public sector information licensed under the Open Government Licence v3.0.