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Published: July 2022
GAMP aims to deliver a cost-effective framework of good practice to ensure that computerized systems are effective and of high quality, fit for intended use, and compliant with applicable regulations.
Maintaining the principles and framework of the first edition, ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) updates their application in the modern world including the increased importance of service providers, evolving approaches to software development, and expanded use of software tools and automation. It highlights the use of critical thinking by knowledgeable and experienced SMEs to define appropriate approaches.
The ISPE GAMP Community of Practice (CoP) performs regular ongoing assessments and reviews of GAMP knowledge against current practices and regulatory and technology developments. ISPE GAMP 5 Second Edition therefore embraces and reflects:
Furthermore, this Guide highlights the importance of applying “critical thinking” by knowledgeable and experienced SMEs when defining the appropriate approach for specific circumstances.
Discussion of current FDA activity on Computer Software Assurance (CSA) approaches and clear links to ISPE/GAMP guidance on Data Integrity (DI) have been added.
The Appendices have been expanded to incorporate new and evolving topics in the life sciences industry such as blockchain, Artificial Intelligence/Machine Learning (AI/ML), cloud computing, and Open-Source Software (OSS).
This Guide is intended for use by regulated companies, suppliers, and regulators. Suppliers include providers of software, hardware, equipment, system integration services, IT service providers, and IT support services, both internal and external to the regulated company.