21 CFR Part 11 — Are You Ready For An FDA Inspection?

By James Jardine

When the U.S. Food and Drug Administration (FDA) issued 21 CFR Part 11 in 1997,1 the internet existed but it was not as ubiquitous as it is today. Google wasn’t around yet. Life science companies submitted documents to the FDA by the truckload because paper records were the norm.

In many ways, Part 11 was an acknowledgement of the inevitable movement toward the use of electronic systems in compliance. The regulation established the criteria for the use of electronic records and electronic signatures by organizations that comply with the Food, Drug, and Cosmetic Act and the Public Health Service Act. It applies to all FDA-regulated companies.

Part 11 has been scrutinized and criticized over the years, but it remains in effect today. Given the pervasive automation of processes and digitization of data today, the regulation is more relevant than ever. In this paper we break down what Part 11 means and how to get inspection ready.