The Food and Drug Administration (FDA) has a regulation called 21 CFR Part 11 that specifies requirements for digital records and electronic signatures. It was put in place within the pharmaceutical, medical product, and biologic industries back in 1997 to ensure the correctness, authenticity, and safety of electronic data and signatures. All digital records that […]| eLeaP®
Audit trails are crucial for Part 11 compliance, providing detailed logs of all electronic record changes, ensuring data integrity, enabling accountability.| eLeaP®
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Explore eLeaP's Revision Controls, ensuring 21 CFR Part 11 compliance through secure, traceable course management features.| eLeaP®
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Guide to GxP compliance in regulated industries, emphasizing data integrity, electronic record management, and cloud computing challenges.| eLeaP®