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
GAMP Good Practice Guides

GAMP Good Practice Guide: Regulated Mobile Applications

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
GAMP Good Practice Guides

GAMP Good Practice Guide: Computerized GCP Systems & Data

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
GAMP Good Practice Guides

GAMP Good Practice Guide: IT Infrastructure Control & Compliance 2nd Edition

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
GAMP Good Practice Guides

GAMP Good Practice Guide: GxP Compliant Laboratory Computerized Systems 2nd Edition

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