GAMP Good Practice Guide: Testing GxP Systems 3rd Edition

Published: July 2026
Pages: 142

• Table of Contents
• Special Pricing for Emerging Economies

As a key component of computerized system validation, testing provides objective evidence that the system is fit for intended use. The ISPE GAMP^® Good Practice Guide: Testing GxP Systems (Third Edition) focuses on effective and efficient testing approaches across the lifecycle.

This Guide promotes the application of critical thinking and selection of testing approaches that are proportionate to risk, complexity, and intended use, enabling regulated companies to detect defects early in the lifecycle. This practice reduces errors during operational use and helps protect patient safety, product quality, and data integrity.

This Third Edition encourages the paradigm shift 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. Information contained in the Guide facilitates the increased use of iterative and incremental approaches, cloud computing, and computerized test tools. Suppliers are encouraged to strengthen their testing approaches, allowing regulated companies to leverage supplier testing more effectively, with the ultimate objective of adopting system updates quickly, safely, and routinely to keep pace with new features and technologies.

The objective of this edition is to achieve effective and efficient testing that:

• Uses QRM and critical thinking to determine the most appropriate approach to verifying the system is fit for intended use and meets specification
• Leverages testing completed earlier in the system life cycle, (by the supplier or regulated company)
• Detects defects prior to system operational use
• Confirms the correct installation, configuration, functionality, and management of the computerized system
• Ensures system changes and upgrades are tested in accordance with criticality, scope, and complexity, including regression testing to ensure other related functionality is not adversely impacted by the change

This Guide builds and expands upon the testing guidance given in ISPE GAMP® 5 (Second Edition) and ISPE GAMP® Good Practice Guide: Enabling Innovation and applies to GxP regulated computerized systems. Also within the scope of this Guide are systems that support regulated activities outside of manufacturing, including clinical trials, Research and Development (R&D), and software in or as medical devices.

Guide Core Team

Ray Murphy

Fellow Software Quality Engineer

Boston Scientific

Christopher Reid

Head of Digital Quality CoE

ProductLife Group

Charlie Wakeham

Director

WakeUp To Quality

For the full list of contributors to this Guide see Guidance Document Teams