As organizations find themselves operating from multiple sites worldwide, with groups and departments split between multiple geographies, or even using third party distributors, the challenges of information sharing become more complex. The GAMP® Good Practice Guide: Global Information Systems Control and Compliance (Second Edition) examines the many challenges of deploying a global IT system while complying with the wide range of regulations and guidelines of different countries.
The Second Edition includes comprehensive and up-to-date guidance on the risk-based development, implementation, validation, and maintenance of GxP regulated global information systems and is fully aligned with GAMP® 5. 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 help regulated companies to achieve effective and efficient risk-based control and compliance of global information systems.
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*Based on the World Bank's system for classifying national economies by GNI per capita. Includes low-income, lower middle-income, and upper middle-income economies. To learn more about the World Bank classification system, please click here. Currently includes the following nations, except where international sanctions apply: