What Best Practices are suggested by GAMP in the field of mobile devices?

The use of mobile devices, such as smartphones, tablets and wearables, is now universal. As reported on the website of FDA, According to industry estimates, 500 million smartphones worldwide will have a health care app by 2015, and by 2018, 50 percent of the more than 3,4 billion smartphone and tablet users will have downloaded mobile health apps. They are health professionals, consumers and patients. With this computing power in everyone's pocket, it was inevitable that even the manufacturers of drugs and medical devices, therefore regulated companies, would see the possibility of using them for many different purposes.

Some examples are:

  • To monitor and improve patient compliance with a medical regimen
  • As a marketing tool and to make medical literature more available to doctors and patients
  • As a channel for communications with patients
  • How to HMI and to manage and monitor a Medical Device

In addition to the above, mobile devices are increasingly used in GxP systems on production plants or in the laboratory, for example:

  • Tools for warehouse management, loading and unloading and handling
  • HMI interface centralized for laboratory instruments and systems
  • Interface for production equipment, possibly with the possibility of managing alarms and setpoints
  • To access business applications, such as ERP, Maintenance, MES, LIMS, CAPA, etc.

The universality of the mobile device market makes it increasingly interesting to develop and use Apps for various uses and it may not be immediately clear that there may be implications for compliance with regulations and standards: in regulated companies, therefore, it becomes critical to raise awareness among all those involved in the design, development, use and maintenance of these Apps.

By their very nature, mobile devices present a significant control challenge. The ability to put regulated applications on everyone's smartphone, some of which can be classified as medical devices, is new ground for the industry. And it's also the first time that regulated software is running on platforms over which life sciences companies have little or no control.

For example, the iPhone used as an electrocardiograph, which was approved by the Food and Drug Administration (FDA) in 2012, is a medical device, and requires a variety of testing just like other sophisticated electronic medical devices. However, many mobile applications are created for other purposes, such as marketing support. In general, unless a mobile application is used only for displaying static information, such as medical literature, the mobile application is likely to be considered regulated. Regulators take this for granted, and have to consider a series of mobile applications as medical devices.