21 CFR Part 11 Compliance: A 2025 Guide for Digital Validation in Life Sciences
Compliance Gurus06 Aug, 2025Business
In 2025, the life sciences industry faces immense pressure to digitize operations while staying fully compliant. As cloud platforms, AI-driven systems, and electronic records become the norm, maintaining regulatory compliance becomes more complex than ever. At the heart of this transformation is 21 CFR Part 11—a key regulation that governs electronic records and electronic signatures in FDA-regulated environments.
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