GAMP Good Practice Guides

GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides pragmatic and practical industry guidance that aims to achieve compliant computerized systems that are fit for intended use in an efficient and effective manner, while also enabling innovation and technological advances.
Reflecting current regulatory expectations and good practices for automated/computerized systems, the GAMP series of Good Practice Guides help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions. They typically focus on the “how”.

Language
English
Published: October 2014 Pages: 96 Table of Contents Special Pricing for Emerging Economies More than 3 billion people worldwide use a smartphone and according to industry estimates almost 60% of those users will download a mobile health application
Published: December 2017 Pages: 128 Table of Contents Special Pricing for Emerging Economies The ISPE GAMP ® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data (Good eClinical Practice) is intended to provide a risk
Published: August 2017 Pages : 168 Table of Contents Special Pricing for Emerging Economies The ISPE GAMP ® Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition) is intended to provide comprehensive guidance on meeting
Published: October 2012 Pages: 160 Table of Contents Special Pricing for Emerging Economies Recently updated to conform with GAMP® 5 concepts and terminology, as well as recent regulatory and industry developments, the ISPE GAMP® Good Practice Guide