Seven years ago, industry was left quite confused when FDA withdrew five draft guidances associated with 21 CFR Part 11, the regulations that focus on electronic records and submissions. The agency issued a Scope and Application guidance a few months after the withdrawals, in August 2003, to help define how it planned to interpret and enforce Part 11 (enacted in 1997) while regulators worked out a more final revision to Part 11 based on industry feedback. That revision has yet to make its debut.

This morning, however, officials from FDA’s Center for Drug Evaluation and Research Office of Compliance shed some light on the status of Part 11 via a press briefing.

George R. Smith, a project management officer in the Office of Compliance and co-chair of the Part 11 Working Group, described the agency’s plans to carry out inspectional efforts tied to Part 11.  The goal, said Smith, is to carry out focused inspections pertaining to Part 11 regulations on human drugs in an effort to help increase industry understanding of and compliance with Part 11. Enforcement actions will be taken when noncompliant activities are determined, he said.

 To explain what this means for industry, here is a bit more background: Since 2003, according to the Part 11, Electronic Records; Electronic Signatures—Scope and Application guidance, FDA enforced “with discretion” those Part 11 records tied to validation, audit trails, legacy systems, copies, and retention. All predicate rule requirements and other sections pertaining to Part 11 such as controls for closed systems, and authority and device checks, had remained in tact and were deemed somewhat “more” enforceable by the agency. It now looks as though those areas that fall under Part 11 and are deemed enforceable will be  included in inspection reviews.

Smith pointed out during the briefing that Part 11 was originally established to apply to all FDA program areas to permit the widest use of electronic technology.  However, the new requirements led to many industry complaints, including comments that Part 11 would restrict use of technology, increase the cost of compliance to an extent not envisioned by FDA, and discourage innovation in technology, all while having no positive public health impact. This feedback led to the withdrawal in 2003 of the five draft guidance documents tied to Part 11 and to the issuance of the Scope and Application final guidance in August 2003.

At this time, it’s unclear what types of new enforcement actions may be taken by FDA during the planned inspectional activities, which are expected to start “soon” according to an FDA notice on the subject. Ideally, the information gained from the inspectional efforts will be used to further modify Part 11 in the future. The agency is expected to post more details on its website later today, July 8, 2010, and Pharmaceutical Technology will update this blog post as information comes in.

Updated: July 9, 2010 2:20 pm EST