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®
Understand the importance of cGMP compliance in the life sciences industry and how it ensures product safety and public health.| eLeaP®
Our Part 11-compliant e-signature solution for seamless integration with eLeaP LMS. Ensure security, compliance, and user-friendly workflow.| eLeaP®
Explore eLeaP's Revision Controls, ensuring 21 CFR Part 11 compliance through secure, traceable course management features.| eLeaP®
Explore eLeaP's Role-based Access Controls, ensuring 21 CFR Part 11 compliance through secure, traceable access control 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®