MHRA · Life Science & Pharma: GxP - CSV & Data Integrity
MHRA 'GXP' Data Integrity Guidance and Definitions
Final Data Integrity · Guidance Last verified: not yet · Source last checked 3 Nov 2026
- Issued by
- MHRA
- Category
- Data Integrity
- Sub Category
- Guidance
- Legal weight
- Guidance & Q&A
The UK regulator's guidance on data integrity across GxP work. Its clear definitions make it a popular starting point for learning the subject.
How to read this page
- The line under the title explains in plain words what this item is for. The coloured label beside its status gives its Category, its main subject, and Sub Category, the type of document, in the same colours as the maps.
- Status comes from the latest dated event below, and each event links to its source.
- Lifecycle shows the steps so far, then any expected target. Targets are not facts.
- In plain English is our own summary, not the official text. Where we have read the document in detail, a fuller profile follows, with its context, scope, contents and key points.
- Related shows links to other documents. Select Compare to see two side by side.
Lifecycle
Solid steps have happened. A dashed step is expected, and it is not a fact. Only dated steps in our record appear here.
- Earlier GMP data integrity definitions and guidance first published
- Earlier GMP guidance updated with clarifications
- Published
- Earlier GMP guidance withdrawn, replaced by this GxP guidance
In plain English
UK guidance and definitions for data integrity across GxP areas, including data governance, ALCOA+, audit trails and computerised system controls.
Summary drafted with AI assistance. Not yet reviewed by the SME Reviewer. Read the official text before acting.
Context and history
The MHRA published this guidance in March 2018, as Revision 1 covering all GxP areas, replacing its earlier GMP-only guidance from 2015. It became one of the most widely used data integrity references, and it introduced many firms to data governance as a formal idea.
Who and what it applies to
Organisations in UK GxP areas, including GMP, GCP, GDP, GLP and GVP. Its principles are applied much more widely.
What it contains
- Background and introduction
- Why data integrity matters, and how to apply these definitions.
- Principles of data integrity
- Data governance, culture and risk.
- Definitions
- Data, metadata, data integrity, data governance, data lifecycle, recording, transfer and migration, processing, original record and true copy, computerised system transactions, audit trail, electronic signatures, data review and approval, computerised system users, passwords, retention, archive, backup and file structure.
- Glossary and references
- Further terms and sources.
Key points
- Data governance should be risk-based and proportionate.
- Senior management is accountable for minimising data integrity risk and for identifying residual risk.
- Organisations should actively encourage the reporting of errors, omissions and undesirable results.
- Contract givers should cover data ownership, governance and access in agreements with third parties.
- Data governance applies across the data lifecycle, from generation to destruction.
- Electronic data should be available in human-readable form, and readily available to authorities on request.
In practice
General reading, not advice. This is drafted with AI and may not fit your situation. It does not replace the official text, your own quality system or qualified advice, and an inspector may take a different view.
- Use it as a teaching text, because its definitions are clear.
- Begin a data governance programme with a data flow for each key system.
- Check whether staff feel able to report data errors, since culture is part of the guidance.
- Add data governance to vendor assurance and technical agreements.
Read from the source document on 1 Nov 2026. This is our own description, not the official text. Check the full dated history in the change log below.
Change log
Key dated events only, not a complete history. Status after is the status once that event happened. Event kinds explained
| Date | Event | Status after | Source |
|---|---|---|---|
| 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) | Final | 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) |
| 4 Apr 2018 | Earlier GMP guidance withdrawn, replaced by this GxP guidance | Final | Source for Earlier GMP guidance withdrawn, replaced by this GxP guidance |
| 9 Mar 2018 | Published | Final | Source for Published |
| 13 Mar 2015 | Earlier GMP guidance updated with clarifications | Final | Source for Earlier GMP guidance updated with clarifications |
| 23 Jan 2015 | Earlier GMP data integrity definitions and guidance first published | Final | Source for Earlier GMP data integrity definitions and guidance first published |
Related
How other documents connect to this one. Links explained
- Related to PIC/S PI 041-1· Compare with PIC/S PI 041-1 Unverified link
- Related to Annex 11 (2011)· Compare with Annex 11 (2011) Unverified link
- Related to Annex 15· Compare with Annex 15 Unverified link
- Risk basis from ICH Q9(R1)· Compare with ICH Q9(R1) Unverified link
Official source
The official text always prevails over anything on this site.
Source: MHRA. Contains public sector information licensed under the Open Government Licence v3.0.
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