GAMP Good Practice Guide: Regulated Mobile Applications


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Published: October 2014
Pages: 96

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. 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 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.