Building a Sustainable Validation Managed Service for Life Sciences

This white paper outlines a practical operating model for organizations in the life sciences sector that require ongoing validation capacity, release confidence, and audit-ready evidence. It discusses the transition from treating validation as a project activity to establishing it as a managed capability due to the complexities of frequent software releases, production defects, and regulatory demands. The paper details the components of a validation managed service, including governance models, team roles, and essential metrics that matter for effective validation. It emphasizes the importance of a structured approach that includes inventory assessments, risk evaluations, and the creation of reusable assets. The document also highlights the need for continuous improvement and the integration of engineering support to enhance validation processes. Additionally, it presents a reference model that outlines the phases of discovering, stabilizing, operating, and optimizing validation efforts to ensure compliance and quality assurance in regulated environments.