Enforcement Lulls as New Part 11 Rule Looms

With smart money betting the FDA won’t release its revised 21 CFR Part 11 rule until the end of the summer or even early fall, the agency’s lack of visible enforcement is sending some mixed signals to industry, experts told PIR.

“Most people are just waiting for the amended version to come out,” noted Ty Mew, president of Ofni Systems. He said that word on the rule “got out enough in the early days” to impress upon industry that it shouldn’t ignore Part 11.

The rule first came out in 1997 but was significantly narrowed in scope with a final guidance released Sept. 3, 2003, in part because industry complained that compliance was so expensive and expansive as to unintentionally retard innovation in erecords. The FDA had originally issued the Part 11 rule with the avowed purpose of advancing the use of erecords among regulated companies.

“There has not been much enforcement activity related to Part 11, mostly because the FDA committee is working hard to get the new Part 11 out,” Rita Geiger, a member of FDA’s Part 11 advisory committee and president of InfoStrength, told PIR. That committee is slated to meet the week of June 6 to continue its discussion on the new Part 11, Geiger said.

There have been no warning letters issued in 2006 through May mentioning Part 11 by name, and just one in 2005, according to a warning letter analysis conducted June 2 by PIR. The 2005 letter came in April to an eye and plastic surgery physician. In the letter, Part 11 is only tangentially mentioned toward the end (PIR, May 25, 2005). There were no Part 11-named warning letters issued in 2003 or 2004, and just one in 2002, according to PIR’s analysis.

It should be noted, however, that some warnings do focus on aspects of erecord retention without citing Part 11 by name. But most would agree that FDA’s enforcement of Part 11 has been in a lull for several years.

FDA inspectors appear to be focusing on Part 11 only when there is a serious shortcoming, Affernex President Ven Thangaraj told PIR. One way to avoid that kind of problem with FDA inspectors is to make certain you can quickly access edata when an inspector asks to see something, he noted. Being unable to do so sounds alarm bells for many inspectors, he added.

Thangaraj doesn’t expect Part 11 enforcement to increase — at least via warning letters — even after the agency issues the new rule. “It is so broad and so hard to point at a few problems, that unless it is a very bad issue such as a lack of audit trails or insecure audit trails where anyone can update it,” inspectors aren’t likely to focus much on Part 11, he said.

But don’t let your guard down too much, Geiger warned. “Inspectors weren’t told to ignore Part 11,” she said. “It would be a mistake” to think the FDA no longer cares about edata integrity, she added.

“The new Part 11 is going to place more responsibility on the industry and address a risk-based approach to validation and controls,” Geiger predicted. “The FDA expects industry to come up with its own risk management methodology” that demonstrates edata integrity, she said.

FDA officials and industry partners are working hard on the revision, Geiger said. Part of the delay has come because the agency expects the new Part 11 to generate many questions and it is trying to anticipate those and prepare answers in advance, she said.

The relative lull in enforcement is a perfect opportunity to assess your firm’s erecord capabilities, Geiger said. “Use this time to think proactively and put controls in place to create quality systems, especially where you are producing erecords that could ultimately be submitted to the FDA,” she said. — Michael Causey