Even now, some uncertainty about Part 11 regulations remains. A contributing factor to this confusion may be the fact that earlier FDA guidelines on the regulation were revoked in 2003 (14) and replaced by a single guideline (15) with the intention of adding other guidelines later. FDA's reasoning behind withdrawing these guidelines (Fed. Register, Docket 00D-1540 in Feb. 2003) was "to avoid loss of time spent by industry in their efforts to review and comment on Part 11 issues that may no longer be representative of FDA's approach under the new GMP initiative." Since then, no additional guidelines have been issued, but FDA is working on a Part 11 amendment (16).
Perspective on the industry's approach
PMA also published other computer validation related articles, mainly in Pharmaceutical Technology, which has published more than 40 articles about computer validation. Historically, this publication played a key role in shaping and spreading understanding of computer validation in our industry. Even individuals from FDA published articles in the journal back then (17). Sadly, this is no longer the case because, for better or worse, FDA is now stricter about allowing its employees to publish. (A list of computer validation–related articles is online at http://pharmtech.com/.) The PMA CSVC was dissolved in the mid 1990s, and the US Parenteral Drug Association (PDA) became the industry's main forum. Part of PDA's computer-validation committee efforts focused on software-supplier audit and the creation of an audit repository center (ARC) (18). The ARC concept, however, has had varying success. Currently, the repository is managed by Syntegra. Since the late 1990s, the main industry forum for computerized systems validation has been the ISPE good automated manufacturing practice (GAMP ) group. The GAMP guideline is widely considered to be the de facto pharmaceutical-industry standard in computer validation. The current GAMP 4 version introduced the risk-management concept into computer validation in 2001, aligning with FDA's effort on GMPs for the 21st century. Currently, GAMP is working on version 5, which is slated for publication in late 2007 or early 2008. It is important to note that GAMP 4 explicitly excludes 21 CFR Part 11, although a separate guideline has been produced.