21 CFR Part 11: Risks Of Noncompliance

By Brian Curran

When 21 CFR Part 11 took effect in August 1997, it was considered one of the most important regulations affecting pharmaceuticals, biotechnology, medical device, and other industries regulated by the FDA. The goal of Part 11 is to allow the use of modern technology in submissions and record keeping while ensuring reliability, authenticity, and validity of electronic records. With this rule, electronic records and signatures became as valid as paper records and handwritten signatures.

Numerous discussions between the FDA and regulated industries ensued, primarily focusing on the scope of interpretation of Part 11. According to the FDA, “Concerns have been raised that some interpretations…would (1) unnecessarily restrict the use of electronic technology in a manner that is inconsistent with FDA’s stated intent in issuing the rule, (2) significantly increase the costs of compliance to an extent that was not contemplated at the time the rule was drafted, and (3) discourage innovation and technological advances without providing a significant public health benefit. These concerns have been raised particularly in the areas of Part 11 requirements for validation, audit trails, record retention, record copying, and legacy systems.”

Due to these concerns, the FDA has embarked on a re-examination of Part 11. In the meantime, the agency issued “Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application” to describe how it intends to exercise enforcement discretion during the re-examination period.

Throughout a recent FDA Guidance for Industry: Part 11, the message is clear: compliance to the underlying predicate rules remains critical; the FDA will enforce predicate requirements for records subject to Part 11. In this article we further explain the guidance, review warning letters, and offer a solution to meet FDA and ISO regulations.