On December 13, 2018, the U.S. Food and Drug Administration (FDA) published the final version of its data integrity guidance, Data Integrity and Compliance With Drug CGMP: Questions and Answers. The document builds on the initial draft version, which was issued in April 2016 in response to an increase in findings of data integrity lapses in FDA-regulated establishments across the world. According to recent remarks by FDA Commissioner Scott Gottlieb, FDA continues to uncover CGMP violations involving data integrity, which prompted the need to finalize the guidance.
The final guidance covers the design, operation and monitoring of systems and controls to maintain data integrity and largely mirrors provisions in the draft guidance, with a few notable exceptions:
Sidley Austin LLP provides this information as a service to clients and other friends for educational purposes only. It should not be construed or relied on as legal advice or to create a lawyer-client relationship.
Attorney Advertising - For purposes of compliance with New York State Bar rules, our headquarters are Sidley Austin LLP, 787 Seventh Avenue, New York, NY 10019, 212.839.5300; One South Dearborn, Chicago, IL 60603, 312.853.7000; and 1501 K Street, N.W., Washington, D.C. 20005, 202.736.8000.