FDAnews
www.fdanews.com/articles/186013-mhra-issues-new-guidance-on-gxp-data-integrity-compliance

MHRA Issues New Guidance on GXP Data Integrity Compliance

March 15, 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.

View today's stories