ISPE/DIA Workshop on Computer Systems Compliance “Maintain Data Integrity to Reduce Risk for the Patient”

The accessibility of mobile platforms to the general public has become nearly universal in much of the world. In 2013 sales of smartphones exceed the sales of standard mobile phones, and this trend shows no sign of slowing. With this much computing power in everyone’s pocket it was inevitable that regulated companies would recognise an opportunity to use it for a variety of purposes. Some examples of leveraging mobile technology are of relatively low impact and will not interest regulators, some fall very clearly into the regulated arena, and finally some are not so clear. Even once the scope of regulatory relevance is settled, mobile devices present a significant challenge to control. 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. Never before has regulated software run on platforms where the process owner has little or no control over the platform. This session is intended to consider a risk-based approach to implementing and supporting mobile devices in a regulated environment.