MHRA's Guidance on GxP data integrity

‘GXP’ Data Integrity Guidance and Definitions.

28th March 2018

MHRA very recently published a guidance on GxP data Integrity.

The guidance is intended to be a useful resource on the core elements of a compliant data governance system across all GxP sectors (good laboratory practice, good clinical practice, good manufacturing practice, good distribution practice and good pharmacovigilance practice).

It addresses fundamental failures identified by MHRA and international regulatory partners during GLP, GCP, GMP and GDP inspections; many of which have resulted in regulatory action.

Please refer to the full copy of guidance document here.

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