In this episode of Software Quality Today, I sit down with Sree K, a seasoned expert in risk-based validation and automation within the life sciences industry. With over 18 years of experience, Sree challenges traditional validation methods and emphasizes the importance of embracing the new Computer Software Assurance (CSA) guidance. We explore how a risk-based approach can enhance efficiency and compliance, particularly for small and mid-sized pharma companies. Sree shares insights on navigating the complexities of validation across diverse roles, the value of automation, and the necessity of ongoing education for quality teams. Join us for an engaging discussion that rethinks the future of validation in our industry.
