Over the last 20 years, FDA regulation of electronic records and signatures has evolved from an idea, to a law, to re-examination of the law.

In this brief online course, you will learn the history of the FDA’s 21 CFR Part 11 Electronic Records and Signatures regulation. The course covers why and how Part 11 was developed, Industry’s reaction to Part 11, the FDA’s multiple attempts to provide guidance on Part 11, and the FDA’s new initiative to assess Industry’s Part 11 understanding and compliance.