Validating AI for CAPA: A Practical Framework for Regulated Industries

A QA engineer prototyped an AI assistant for CAPA triage in a medical device environment, facing the challenge of validating probabilistic models under 21 CFR 820 and ISO 13485. They developed a controlled-assistance pattern with golden-test corpora, acceptance metrics, and human-in-the-loop controls. The approach emphasizes process validation over model validation, enabling regulatory acceptance.