AIForbes Innovationabout 2 hours ago
Your AI Model Passed Validation But Your FDA Audit Didn't, Here's Why
1 min read
Maritza Diaz, CEO at ITJ, explains that AI model validation does not guarantee passing an FDA audit. Regulators require end-to-end traceability, controlled model evolution, human oversight, and performance transparency. Teams must architect for compliance early and create cross-functional governance to avoid costly remediation.
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