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21 CFR Part 11 Software Requirements [Explained]

21 CFR Part 11 Software Requirements [Explained]

by Germans Frolovs | Oct 8, 2019 | Regulations

FDA 21 CFR Part 11 is a regulation that governs how Medical Device, Pharmaceutical, and other FDA-regulated companies should handle their electronic records and electronic signatures. The Life Science Industry is known for a vast number of regulations and various sets...

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