Article | August 20, 2024

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

Source: CAI

By Brian Stephens, Assistant Director

Part-3

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of a three-part series examining lessons learned during the validation of two software systems using the FDA's CSA draft guidance.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.

access the Article!

Get unlimited access to:

Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue. X

Enter your credentials below to log in. Not yet a member of Pharmaceutical Online? Subscribe today.

Subscribe to Pharmaceutical Online X

Please enter your email address and create a password to access the full content, Or log in to your account to continue.

or

Subscribe to Pharmaceutical Online