GAMP Good Practice Guide: Global Information Systems Control and Compliance

This Guide provides an understanding of the issues faced by teams that are tasked with completing a global deployment of an IT system, in particular, to provide some insight into addressing issues of control and regulatory compliance efficiently and effectively. The Guide encompasses a wide range of regulations and guidelines, including US FDA regulations and GPGs, relevant sections of EU GMPs, PIC/S Guidance, Health Canada GMP regulations, and ICH Guidelines.