MHRA GXP Data Integrity Guidance and Definitions, 3/18

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In March, 2018, the MHRA published a revision to their 2015 version of GMP Data Integrity Definitions and Guidance.  This guidance is intended to complement existing EU GMP relating to active substances and dosage forms, and should be read in conjunction with national medicines legislation and the GMP standards published in Eudralex volume 4.

This guidance contains definitions and associated expectations for compliance on 20 topics. Key guidelines include those for:

• Metadata
• Data Integrity, Governance, and Lifecycle
• Data Transfer and Migration*
• Data Processing*
• Data Recording and Excluding*
• Raw Data, Original Records, True Copies
• Audit Trail
• Electronic Signatures*
• Data and Audit Trail Reviews
• Computerised System User Access
• System Administrator Roles
• Data Retention, Backup, and Archival
• Validation for Intended Purpose
• Cloud Providers (SaaS, PaaS, IaaS)*

* New in this version

The MHRA guidance also outlines validation expectations for:

• Validation of system configuration settings and protection from unauthorised modifications
• Validation of audit trails and audit trail reports
• Validation of system back-up, archival, and recovery processes
• Intended use testing of systems where the vendor has completed function verification
• Testing of business continuity arrangements