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21 CFR Part 11

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Blog

Beginner’s Guide to 21 CFR Part 11 Compliance

FDA released regulations in 1997 outlining how 21 CFR Part 11 applies to electronic records and electronic signatures in clinical research.

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Info Sheet

Advarra eConsent

Simplify oversight and expand remote consenting capabilities with Advarra’s 21 CFR Part 11 compliant electronic consent management system.

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