MHRA Issues New Guidance on GXP Data Integrity Compliance

March 16, 2018

The U.K.’s Medicines and Healthcare products Regulatory Agency released new guidance on its approach to GXP data integrity and its expectations for achieving compliance.

The guidance places a strong emphasis on implementing corrective and preventive actions across all relevant systems and activities where data integrity weaknesses are found and notifying regulatory authorities when necessary.

Expanding on a draft document the agency issued in July 2016, the new guidance includes revised definitions, examples and interpretations of requirements for various data integrity terms.

MHRA suggests making original records available for staff performing data review activities and using controlled books with numbered pages to prevent recreation of records.

The agency also recommends using external devices or methods to eliminate manual data entry and human interaction with a computer system, such as ID card readers or barcodes.

The guidance primarily addresses data integrity and not data quality “since the controls required for integrity do not necessarily guarantee the quality of the data generated,” the agency noted.

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