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A Risk-Based CSA Framework for Validating Generative AI in GxP Environments
By Neelank Tiwari, MS, PMP, CMQ-OE, CQA, CMDA, CSQP - DEKRA-qualified ISO 13485 Lead Auditor
Author's note, August 2026: I wrote this framework in 2025, before FDA's Quality Management System Regulation went into force in February 2026. Six months of QMSR enforcement have only sharpened
Where the First QMSR Inspections Are Biting — and a Free Way to See Your Exposure
The QMSR has been in force since February 2, and the first wave of FDA inspections under it now has a visible pattern.
Per FDA CDRH's own readout of the first ~100 QMSR inspections — reported by Keisha Thomas (Associate Director, CDRH Office of Product Evaluation and Quality) at