The FDA Just Issued Its First AI Warning Letter. Here's What Every QMS Vendor Doesn't Want You to Ask.
On April 2, 2026, the FDA cited a drug manufacturer for over-reliance on AI. 'The AI said so' is now a cGMP violation. A deep dive into the validation problem that every QMS vendor is avoiding: how do you validate a system that gives different answers to the same question?
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Saram Consulting