Chicken Little Was Right: FDA Will Enforce Part 11 "Soon"
I’ve got to admit, despite months (or years?) of hearing from those inside and close to the FDA that the agency intended someday to begin actual enforcement of 21 CFR Part 11, I was beginning to have my doubts.
No one likes to be told he’s crying wolf or acting like Chicken Little squawking about the sky falling.
Finally, however, the FDAs CDER division issued a blandly worded release that may have some serious repercussions for regulated drug companies:
The FDA “will be conducting a series of inspections in an effort to evaluate industry’s compliance and understanding of Part 11 in light of the enforcement discretion described in the August 2003 ‘Part 11, Electronic Records; Electronic Signatures — Scope and Application’ guidance (Guidance). The Agency intends to take appropriate action to enforce Part 11 requirements for issues raised during the inspections that do not fall under the enforcement discretion discussed in the Guidance.”
That’s about all they said publicly, but it’s a mouthful after waiting a long long time for any agency activity backing the Part 11 rule.
While this announcement focuses on drugs, don’t be surprised to find a similar action coming soon on the device side.
“I’d expect FDA inspectors to focus on Part 11, too, when they inspect device manufacturers,” agrees former FDA inspector Ken Miles.
When it comes to preparing for FDA inspections, Ken says he’s a big fan of the Boy Scouts motto: Be prepared.
We’ve heard in the past that many FDA inspectors weren’t comfortable yet inspecting or enforcing Part 11 provisions. The result: Very few inspections, and some inconsistent inspectors.
In the coming weeks, we’ll report back on what kind of inspections FDAers are conducting, and how you can best prepare for them.