Published: March 2017 Pages: 152 Table of Contents Special Pricing for Emerging Economies The ISPE GAMP ® Guide: Records and Data Integrity provides principles and practical guidance on meeting current expectations for the management of GxP regulated
Maintaining the principles and framework of the First Edition, GAMP® 5 (Second Edition) is newly revised and expanded to address the increased importance of service providers, evolving approaches to software development, and the more widespread use of software tools and automation. It highlights the use of Critical Thinking by knowledgeable and experienced SMEs to define appropriate approaches.