A journey along the 21 CFR Part 11 Life Cycle

Abstract

The Food and Drug Administration's (FDA) Guidance to Industry on 21 Code of Federal Regulations (CFR) Part 11 attempts to explain how industry can develop work processes that allow flexibility with this regulation without compromising compliance. However, to take advantage of this flexibility, our company needed to clearly understand the impact this guidance could have on our current work processes. We focused our attention on two specific areas: (1) developing and deploying a risk assessment and management process, and (2) revising our Part 11 Life Cycle for computerized systems. Copyright © 2005 John Wiley & Sons, Ltd.