Beginner’s Guide to 21 CFR Part 11 Compliance
Advarra
SEPTEMBER 8, 2022
Computer systems used for clinical trials fall under Food and Drug Administration (FDA) 21 CFR Part 11. This applies to electronic data and signatures submitted under records requirements under other regulations such as: Federal Food, Drug, and Cosmetic Act. What is 21 CFR Part 11? Public Health Service Act.
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