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Latest News
Pre-Trained, Not Pre-Qualified: The QA Risk Behind Third-Party AI Models
Key Takeaways A pre-trained AI model should be treated as a governed AI component, not an invisible technical feature. Pre-trained models should enter through the company’s AI Governance Policy: inventory, ...
When AI Missed Process Validation — and QA Didn’t Catch It: Lessons from FDA’s First AI Warning Letter
Generative AI · QA Literacy · AI Governance · CSV/CSA · GxP Compliance · Inspection Readiness By Ricardo Torres-Rivera, PMP · CEO/President, Xevalics Consulting, LLC Article Summary On April 2, ...
