Learning Management & Talent Development Insights
For 20 years, eLeaP® has helped organizations achieve excellence through learning, performance, & quality.
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Technical Controls for Electronic Records and Signatures
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 […]
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Understanding the Impact of 21 CFR Part 11 on Your Organization
21 CFR Part 11 is the legal framework that controls how businesses handle electronic documents and signatures. To comply with the FDA’s statutory inspection requirements, the regulation develops a framework for managing records and electronic signatures, making them generally similar to paper archives and handwritten signings completed on paper. Here, we’ll be taking a deeper […]
