MHRA ‘GXP’ Data Integrity Guidance and Definitions
The MHRA published ‘GXP’ Data Integrity Guidance and Definitions in March 2018.
The scope of this guidance is designated as ‘GXP’ in that everything contained within the guide is GXP unless stated otherwise. This provides guidance for UK industry and public bodies regulated by UK MHRA including Good Laboratory Practice Monitoring Authority. This guidance promotes the use of a risk-based approach to data management that includes data risk, criticality, and life cycle. This guidance should be read in conjunction with the applicable regulations and the general guidance specific to each GXP.