Frederic Landry

Explore the key differences between expert systems and AI systems in GxP-regulated environments. Learn how AI is transforming compliance, validation strategies, and decision-making in life sciences, and what organizations must consider to balance innovation, data integrity, and regulatory requirements

Computerized system validation in Life Sciences cannot be purchased as a “pre-validated” product. While vendors may offer qualification documentation and testing packages, regulatory agencies require companies to validate systems within their own processes, workflows, and quality programs. Understanding the difference between qualification and validation is critical to maintain compliance and avoid costly regulatory risks.

Is it mandatory to classify UAT records as raw data in pharma and biotech? Discover why executed UAT evidence may not be reconstructible and why raw data–like controls improve validation traceability and inspection readiness.