MHRA 'GxP' Data Integrity Guidance and Definitions
The MHRA’s cross-GxP data integrity guidance (Revision 1, March 2018). Defines the ALCOA+ attributes — attributable, legible, contemporaneous, original, accurate, plus complete, consistent, enduring, and available — and sets expectations for data governance across the whole data lifecycle, for paper, electronic, and hybrid records alike.
What this does not cover
stated in the document's own scope- Provides data-integrity principles across GxP; it is not a computerised-system validation methodology — that role belongs to GAMP 5 and EU GMP Annex 11.
- Is interpretive guidance, not a standalone regulation; the binding requirement remains the underlying UK GxP frameworks it interprets.
- Addresses record and data integrity generally, not the US electronic-records and signatures rule 21 CFR Part 11, which is a distinct instrument.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
The MHRA’s ‘GXP’ Data Integrity guidance (Revision 1, March 2018) is a cross-GxP guidance on maintaining the integrity of data across GMP, GCP, GLP, GDP and GPvP. It defines the ALCOA+ attributes — attributable, legible, contemporaneous, original and accurate, plus complete, consistent, enduring and available — and frames data integrity as something to be assured through data governance across the whole data lifecycle. It applies the same principles to paper, electronic and hybrid records, and explains concepts such as raw data, true copy, metadata, audit trail and the risk-based effort proportionate to the data’s importance to product quality and patient safety.
Scope & applicability
All GxP data (GMP, GDP, GCP, GLP, GVP) generated by organisations regulated by the MHRA — deliberately written as a single set of data integrity definitions and expectations across disciplines and record media.
Legal basis & how it acquires force
The document is MHRA guidance, not a statute in itself: it interprets data-integrity expectations that are already implicit in the existing UK GxP frameworks — the GMP and GDP requirements and the associated regulations the MHRA administers. Its status is interpretive, explaining how those established obligations apply to record integrity, so the binding requirement remains the underlying GxP regulations while the guidance supplies a common vocabulary and set of expectations. It is deliberately written to apply across the GxP disciplines rather than to a single regulation.
Document structure
| Part | Covers |
|---|---|
| Principles and definitions | ALCOA+ attributes and the key terms — raw data, true copy, metadata, audit trail |
| Data governance | The organisational framework and management responsibility for assuring data integrity |
| Data lifecycle | Integrity across generation, processing, review, retention, retrieval and disposal of data |
| Record formats | How the principles apply to paper, electronic and hybrid records |
| Design and risk | Designing systems and applying effort proportionate to the data’s importance to quality and safety |
Key requirements
- Establish a data governance system covering people, processes, and technology
- Assess data criticality and inherent risk across the full data lifecycle
- Ensure records meet ALCOA+ whether paper, electronic, or hybrid
- Enable, review, and retain audit trails for GxP-relevant changes
- Control blank forms/templates so unofficial reprocessing is detectable
- Segregate system administrator rights from data-generating roles
Implementation tips
- Adopt the MHRA definitions verbatim in your data governance SOP — it removes debate during inspection
- Risk-rank systems by data criticality first; depth of control should follow that ranking
- Make audit-trail review frequency and scope explicit (what, who, how often) rather than "periodic"
- For hybrid systems, define which record is the raw data and how the paper/electronic pair is reconciled
Revision notes
Revision 1 (March 2018) superseded the 2015 GMP-only version, extending scope to all GxP. It remains the MHRA’s current data integrity reference and is widely cited alongside PIC/S PI 041 and WHO data integrity guidance.
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
The guidance shares its ALCOA+ framing with the other major data-integrity references — the PIC/S PI 041 guidance and the WHO annex on good data and record management practices — so the principles are common across GxP internationally. It complements computerised-system expectations such as GAMP 5 and EU GMP Annex 11 on the electronic side, while extending the same integrity principles to paper and hybrid records.
MHRA GxP DI (2018): frequently asked questions
Quick answers to common questions about MHRA GxP DI (2018).
What does ALCOA+ stand for in the MHRA guidance?
Attributable, Legible, Contemporaneous, Original and Accurate — the ALCOA core — plus Complete, Consistent, Enduring and Available. The guidance applies these attributes to paper, electronic and hybrid records across the data lifecycle.
Which GxP disciplines does the guidance cover?
It is a cross-GxP guidance, applying across GMP, GCP, GLP, GDP and GPvP rather than to a single discipline.
Is the MHRA data-integrity guidance a regulation?
No. It is interpretive guidance that explains how data-integrity expectations already implicit in the UK GxP frameworks apply; the binding requirement remains those underlying regulations.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.