MHRA GxP Data Integrity Guidance
MHRA 'GxP' Data Integrity Definitions and Guidance for Industry · mhra di guide · mhra 2018 data integrity
UK MHRA guidance interpreting ALCOA+ across GMP, GLP, GCP and GDP, with explicit expectations for paper, hybrid, and electronic systems.
MHRA's 2018 GxP Data Integrity guidance gives the UK regulator's interpretation of data integrity across all GxP domains. It defines data ownership, raw-data and metadata expectations, data lifecycle, and the controls expected for paper, hybrid, and electronic systems — including audit trail review frequency, blank-form control, and risk-based DI assessments.
V5 implements these expectations natively: hashed audit trails, contemporaneous capture, attribution, no shared logins, and admin-visible audit-trail reviews on every record.
- MHRA GxP Data Integrity (Mar 2018)
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