The FDA has increasingly observed cGMP violations involving data integrity during inspections. The purpose of the data integrity guidance is to help manufacturers have the tools and systems in place to prevent adulterated products from entering the U.S. marketplace. The primary areas of focus of the data integrity guidance, as it relates to document control, are on record retention, audit trails, control of the original documents, and any blank forms or copies that were not used.

In this paper, Kevin Bogert examines the FDA’s data integrity guidance document and observations related to control of documents, both electronic and hardcopy.

Kevin Bogert is currently Managing Member of Azimuth Compliance Consulting. He has more than 35 years of business experience, 30 of them in the life science industry, where he has been involved in global implementations of training, quality, and regulatory systems. His background includes statistics, quality and regulatory systems, computer and process validation, and automation of manufacturing processes.

He can be contacted at: kbogert@azimuthcc.com