Lessons Learned From Implementing The FDA's CSA Guidance: Part 3 – Summarizing

By Brian Stephens, Assistant Director

This is the final installment of a three-part series examining lessons learned during the validation of two software systems using the FDA's CSA draft guidance. While the validation process culminates in a functional system ready for its intended use, the true challenge often begins afterward.

Creating a comprehensive validation summary report is essential for demonstrating compliance and facilitating audits. However, when employing CSA methodology, this task becomes particularly complex due to the distributed nature of validation deliverables. This article explores the challenges encountered during the summary phase and offers practical strategies to enhance report clarity and effectiveness, ultimately improving a reviewer's understanding of the validation process and its adherence to the validation plan.