GAMP® Good Practice Guide: A Risk-Based Approach to Regulated Mobile Applications

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Published: October 2014

Pages: 96
Table of Contents ( 705 KB)

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According to industry estimates, 500 million smartphone users worldwide will be using a health care application by 2015, and by 2018, 50 percent of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications. By their very nature mobile devices present a significant challenge to control, and the possibility of putting regulated applications, some of which may be classified as medical devices, into the pockets of the public is new ground for the industry. This new Good Practice Guide is intended to provide a risk-based approach to implementing and supporting regulated mobile apps, and will be of value to both regulated organizations and mobile app suppliers. It focuses on the unique and specific issues related to mobile apps and provides comprehensive guidance for maintaining compliance and control throughout the lifecycle by applying GAMP principles.


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