Volume 6, Issue 2 p. 69-74
Article
Free Access

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

Angela Carter

Corresponding Author

Pfizer Global Research & Development, Ann Arbor Labs, 2800 Plymouth Road, Ann Arbor, MI 48105, USA

Angela Carter, Pfizer Global Research and Development, Ann Arbor Labs, 2800 Plymouth Road, Ann Arbor, MI 48105, USASearch for more papers by this author
Mary Lou Clark

Pfizer Global Research & Development, Ann Arbor Labs, 2800 Plymouth Road, Ann Arbor, MI 48105, USA

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First published: 10 May 2002

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.

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