Published: February 2017
This revised GAMP® Good Practice Guide provides comprehensive and up-to-date guidance on the risk-based development, implementation, validation, and maintenance of GxP regulated global information systems. It provides an understanding of the unique aspects of global systems and the issues faced by teams tasked with completing a global deployment.
This Guide is also fully aligned with ISPE GAMP® 5, and provides guidance on good practice for unique aspects of computerized systems implemented on a global basis. It reflects changes in typical system architecture since the First Edition, and also covers Software as a Service (SaaS) and other cloud solutions.
It will assist regulated companies to achieve effective and efficient risk-based control and compliance of global information systems.