Talk:ComplianceQuest

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21 CFR Part 11 is the FDA guideline defines the criteria under which electronic records and electronic signatures considered to be trustworthy, reliable and equivalent to paper records. Part 11, as it is commonly known and was introduced in 1997, applies to FDA-governed industries that choose to store their primary, authoritative records electronically. It stipulates guidelines and rules for storage, copying, access & permissions, audit logs & tracking. It also identifies version control of electronic records and application of electronic signatures to them.

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