Your Ultimate Guide to 21 CFR Part 11 | Electronic Records & Signatures | US FDA GxP Requirements
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Your Ultimate Guide to 21 CFR Part 11 | Electronic Records & Signatures | US FDA GxP Requirements
🚀 Understanding 21 CFR Part 11: The Backbone of Electronic Data Integrity in Clinical Research & GxP EnvironmentsIn today’s digital era, most regulated activities from clinical trials to pharmacovigilance systems rely on electronic records and electronic signatures (ERES).That’s where 21 CFR Part 11 comes in. Issued by the US FDA, this ...
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