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2002•The Quality Assurance JournalRequires access

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

Angela Carter, Mary L. Clark

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Abstract

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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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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Available abstract

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.

Key concepts: Checklist, Sorting, Process (computing), Sample (material), Computer science, Knowledge management, Engineering management, Process management

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