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.
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.
- 01Establish a data governance system covering people, processes, and technology
- 02Assess data criticality and inherent risk across the full data lifecycle
- 03Ensure records meet ALCOA+ whether paper, electronic, or hybrid
- 04Enable, review, and retain audit trails for GxP-relevant changes
- 05Control blank forms/templates so unofficial reprocessing is detectable
- 06Segregate system administrator rights from data-generating roles
Revision 1 (March 2018) superseded the 2015 GMP-only version, extending scope to all GxP.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.
MHRA GxP DI (2018): frequently asked questions
Quick answers to common questions about MHRA GxP DI (2018).
What is MHRA GxP DI (2018)?
MHRA GxP DI (2018) — MHRA 'GxP' Data Integrity Guidance and Definitions — is a guidance issued by the Medicines and Healthcare products Regulatory Agency (United Kingdom). 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.
Who does MHRA GxP DI (2018) apply to?
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.
What are the key requirements of MHRA GxP DI (2018)?
MHRA GxP DI (2018) requires, among other things: 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.
When was MHRA GxP DI (2018) last updated?
The current version of MHRA GxP DI (2018) dates from March 2018. 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.
Ready-to-use templates designed to help you comply with MHRA GxP DI (2018).
Browse 1 related template →Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When MHRA GxP DI (2018) — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.