Assessing computer systems against 21 CFR Part 11: developing a checklist

Abstract A 21 CFR Part 11 Checklist can satisfy many business, process, and educational needs of companies that use computer systems that must comply with Part 11. This article identifies a strategy for creating your own Part 11 Checklist. Suggestions are presented for: analyzing and sorting the regulations into manageable units; organizing the Checklist; adding supportive information to help users understand and navigate through the Checklist; and including enhancement features such as information mapping and special software. Finally, a sample excerpt from our own Checklist is provided. Copyright © 2002 John Wiley & Sons, Ltd.