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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)
• 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)
Download:
21CFR part 11 - overview (English) ~ 270KB (pdf - 267 KB)
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