FDA Guidelines on Electronic Records

by Foster Sayers

21 CFR 11, title 21, part 11 of the Code of Federal Regulations concerns the FDA’s guidelines on electronic records and electronic signatures. Part 11 sets forth the criteria under which electronic records and signatures can be deemed to be of equivalent reliability to paper records.

For medical device manufacturers Part 11 requires them to implement controls, including audits, system validations, audit trails, electronic signatures, and documentation for software and systems involved in processing electronic data that are either required to be maintained by the FDA predicate rules or used to demonstrate compliance to a predicate rule. A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11.

To date, Part 11 has already been impacting manufacturers that are creating instructions for use electronically and taking other paper records to a digital format.

As UDI approaches, Part 11 will be operative as companies prepare the electronic submissions of data that will go to the FDA. MDDTrack is fully compliant with Part 11 and helps organizations ensure that audit trails and all relevant documentation fully follows all FDA guidelines.