Open AccessA journey along the 21 CFR Part 11 Life Cycle
Author(s) -
Siconolfi Richard M.
Publication year - 2005
Publication title -
the quality assurance journal
Language(s) - English
Resource type - Journals
eISSN - 1099-1786
pISSN - 1087-8378
DOI - 10.1002/qaj.337
Subject(s) - flexibility (engineering) , food and drug administration , work (physics) , risk analysis (engineering) , engineering , process (computing) , operations management , process management , business , engineering management , computer science , management , economics , mechanical engineering , operating system
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.