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- W1971633942 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." @default.
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- W1971633942 date "2002-01-01" @default.
- W1971633942 modified "2023-09-27" @default.
- W1971633942 title "Assessing computer systems against 21 CFR Part 11: developing a checklist" @default.
- W1971633942 doi "https://doi.org/10.1002/qaj.176" @default.
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