GAMP 5 A Risk-Based Approach to Compliant GxP Computerized Systems 2ed 2022

Textbook in PDF format

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.
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