Beyond Installation, Operational, and Performance Qualifications: A Risk-Based Validation Framework for AI-Driven Software in GxP Environments

Computer system validation has governed good-practice software compliance for decades, but software driven by artificial intelligence presents a fundamentally different challenge. Applying conventional qualification protocols to such systems only captures performance at a single moment and is not a durable assurance of ongoing fitness for purpose. An industry expert shares how organizations can close that validation gap within existing regulatory guidance.