Tuesday, 13 September 2016

MHRA GxP Data Integrity Definitions and Guidance for Industry


The U.K. Medicines and Healthcare products Regulatory Agency have issued a new guidance document relating to data integrity.

The way in which regulatory data is generated has continued to evolve in line with the introduction and on-going development of supporting technologies, supply chains and ways of working. Systems to support these ways of working can range from manual processes with paper records to the use of computerised systems. However the main purpose of the regulatory requirements remains the same; having confidence in the quality and the integrity of the data generated and being able to reconstruct activities remains a fundamental requirement.

The document can be accessed here: MHRA






Posted by Dr. Tim Sandle