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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.

Computerized systems are central to GMP compliance in Life Sciences. This article explores the role of IT under GMP, regulatory expectations for system validation, and how effective alignment between Quality Assurance (QA) and Information Technology (IT) ensures compliant, reliable, and audit-ready operations.