CFR Posted On
CFR

Guidance for Industry (Part 11)CFR:

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This guidance is intended to describe the Food and Drug Administration’s (FDA’s) current thinking regarding the compass and operation of […]

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Electronic Records Posted On
Part 11

Part 11-Electronic Records:

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The regulations in this part set forth the criteria under which the agency considers electronic records, electronic autographs, and handwritten […]

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21 CFR Part 11 Posted On
21 CFR Part 11

FDA 21 CFR Part 11 Compliance:

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Compliance with U.S. Food and Drug Administration (FDA) 21 CFR Part 11 is important for regulated companies using electronic records […]

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