20 years later, 21 CFR Part 11 is more relevant than ever – by Cindy Fazzi, MasterControl Staff Writer

If 21 CFR Part 11 and the life science industry were a married couple, they would be celebrating their platinum wedding anniversary this year. For better or for worse, in sickness and in health, it has been 20 years of compliance. It’s an important milestone to celebrate and think about.

First off, what’s new with Part 11? Every now and then, there are rumors about updates. The on-again, off-again speculation stems from the FDA’s “Guidance for Industry: Part 11, Electronic Records; Electronic Signatures—Scope and Application.”

The 2003 guidance says: “While the re-examination of Part 11 is underway, we intend to exercise enforcement discretion with respect to certain Part 11 requirements” (1). And yet, neither re-examination nor update is apparent.

I spoke to a media officer at the FDA’s Center for Drug Evaluation and Research (CDER), but she refused to be quoted. She referred me to CDER’s Division of Drug Information, which said in writing, “The public is notified when any of our guidances are published via Federal Register announcements. Note that the guidance document you are referring to is not included in the 2017 Guidance Agenda.”

In other words, the 2003 guidance remains the same. It remains the key to the FDA’s thinking about the use of electronic systems in compliance. Click here for the full article.