Currently browsing "Part 11"
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21 CFR Part 11 Compliance: How Learning Management Systems Enable FDA-Regulated Training
Understanding 21 CFR Part 11 in the Training Context 21 CFR Part 11 establishes FDA criteria for electronic records and electronic signatures in regulated environments. For life sciences organizations, this regulation fundamentally shapes how training documentation, qualification records, and compliance data must be managed. The regulation requires that any electronic system used to maintain GxP-relevant […]
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21 CFR Part 11 Compliance: The Definitive Guide to Electronic Records and Signatures
Introduction — The Digital Transformation of FDA-Regulated Environments The late twentieth century brought a decisive shift in how FDA‑regulated organizations created, used, and retained information. Paper‑based procedures—once the backbone of quality systems—struggled to keep pace with increasingly complex supply chains, globalized development, and the need for rapid decision‑making. In this context, the U.S. Food and […]
