21CFR part 11 - overview - METTLER TOLEDO

21CFR part 11 - overview

In laboratories these days, everyone is talking about 21 CFR part 11. This article shows what this regulation of the American Food and Drug Administration means in practice:

• What is 21 CFR part 11?
• Definitions
• The regulation in detail
• Electronic records
• Electronic signature
• Prevention of unauthorized access

(Article extract from Analytical Chemistry UserCom 7)

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