21 CFR Part 11 Industry Overview: Ready For An FDA Inspection?Source: MasterControl
The U.S. Food and Drug Administration (FDA) issued 21 CFR Part 11 in 1997 to establish criteria for the use of electronic records and electronic signatures by organizations that comply with the federal Food, Drug, and Cosmetic Act and the Public Health Service Act. Part 11 applies to all FDA-regulated companies, such as pharmaceutical, medical device, biotech, blood, and biologics companies, and contract research organizations.
Over the years, Part 11 has been analyzed, scrutinized, and criticized. Detractors complained that it was too broad and costly to implement. The FDA has issued two guidances on Part 11’s scope and application. The first was released in 2001 (eventually withdrawn) and another was issued in 2003. FDA officials have explained and defended Part 11 in countless conferences and public forums.
After all that has been said and done, how relevant is Part 11 today? The regulation continues to stir lively discussions between critics and advocates. Every now and then, rumors about a possible update of the FDA’s 2003 guidance surface.