Steering a course for risk assessment: The impact of new draft guidance, 21 CFR part 11, scope and application, on the electronic records; electronic signatures rule

Abstract

AbstractAs a result of some re‐organization in the US Food and Drug Administration (FDA) and the introduction of the CGMP risk‐based approach, 21 CFR Part 11 is being revisited. The FDA has decided to re‐evaluate Part 11 and during the re‐evaluation, the FDA issued guidance on how Part 11 will be interpreted. The proposed guidance defines the FDA's approach to the scope and application of Part 11. The draft guidance has substantial regulatory impact by withdrawing previous Part 11 draft guidance as well as the Compliance Policy Guide 71523.17.The scope of Part 11 is defined to be records required by predicate rules kept electronically in lieu of paper records or relied upon for regulated activities, as well as records submitted to the agency, and electronic signatures. Emphasis is given to following predicate rule requirements.In applying Part 11, the FDA will exercise enforcement discretion in the areas of audit trail requirements, validation, copying electronic records, electronic record maintenance, and legacy systems. Emphasis is given to creating and following documented Risk Assessment practice.This article examines the change in FDA focus and highlights key points in the draft guidance. Further, this article provides practical advice for industry, provides an overview on comments (industry feedback) submitted to the Agency on the guidance, and provides an interpretation of the likely direction for future Part 11 regulation. Copyright © 2003 John Wiley & Sons, Ltd.