As AI adoption accelerates across life sciences, organizations face a critical challenge: determining when AI becomes relevant to GxP compliance. But is asking whether an AI solution is GxP or non-GxP really the right question? This whitepaper explores a practical, risk-based framework for evaluating AI, based on its influence on regulated decisions, patient safety, product quality, and data integrity. Discover how to assess AI risk, human oversight, and validation requirements while building governance strategies that enable responsible innovation and regulatory compliance in an evolving AI landscape.