Performance Qualification

Here's the framework for it right now.

Validating an AI system in a cGMP environment follows the same underlying philosophy as validating any other quality critical computer system, installation qualification, operational qualification, and performance qualification, IQ, OQ, PQ, but with additional considerations specific to how machine learning models behave differently from traditional deterministic software.

Installation qualification confirms the system is installed correctly, hardware specification, network configuration, integration with your MES or QMS, and access controls that meet twenty-one CFR Part Eleven requirements.

This part is similar to qualifying any other automated equipment.