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Is Mango compatible with 21 CFR Part 11 ?
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Hi All,
Is Mango compatible with 21 CFR Part 11 ?
21 CFR Part 11 : https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
Thanks!
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@nurr
I am guessing the answer is no since Mango does not enforce annotation for user actions. that is one of requirements of fda. -
@cwangv
Actually, Mango logs audit events for edit, delete, create user actions.
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