Eval suites are qualification protocols in regulated settings

In pharma, a performance qualification (PQ) protocol defines acceptance criteria, executes tests, and records results. An eval suite does the same thing: it defines what success looks like (assertions), runs tasks (test cases), and tracks pass rates over time. The vocabulary differs; the structure is identical.

This mapping means eval-driven development is not just a best practice in GxP settings; it is the validation strategy. A suite of 50 to 200 tasks covering failure modes, edge cases, and real-world scenarios is a PQ document. The traceability matrix connects each requirement to an eval to a production monitor. When a regulator asks ‘how do you know this AI works?’, the eval suite is the answer.