Host Nina Ricciardelli and expert John Cheshire explore the shift from traditional, documentation-heavy CSV to a risk-based approach. This episode defines risk-based validation as an intelligent, targeted method focused on value, efficiency, and early identification of critical risks to enhance patient safety. They address common barriers like organizational culture and clarify that regulators emphasize validation goals over prescriptive documentation. The discussion also covers practical steps, like pilot schemes, for building confidence, necessary QMS adaptations, and the feasibility of risk-based validation even without dedicated digital tools. The core takeaway: begin by defining clear user requirements and intended system use.