08/14/2026
The ISPE GAMP® Good Practice Guide: Testing GxP Systems (Third Edition) is now available. As a key component of computerized system validation, testing provides objective evidence that the system is fit for intended use. This Guide focuses on effective, efficient testing approaches across the system life cycle, promoting the application of critical thinking and testing approaches proportionate to risk, the system's complexity, and intended use.
The third edition supports the transition from testing primarily to provide audit or inspection evidence toward testing as a means of improving system and product quality. It offers guidance on right-sizing testing by optimizing test planning, test coverage, and test evidence, and facilitates the increased use of iterative and incremental approaches, cloud computing, and computerized test tools. This Guide builds and expands upon the testing guidance given in ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition).
Learn more and guide the Guide: https://hubs.la/Q04sGHpB0
