Compliant Regulated Mobile Applications
Mobile applications are as common as sliced bread. With 17,000 mHealth applications currently in the major app stores, I’m sure you’re thinking why doesn’t my company have a mobile app? But before you rally the troops, review the challenges and pitfalls in implementing a mobile application discussed at the ISPE 2015 Annual Meeting by Randy Perez, Director, Information Governance Management at Novartis Pharmaceuticals and Erik Anderson, Sr. Manager, Quality Computer Systems Validation at Johnson & Johnson during the Compliant Regulated Mobile Application session.
Key challenges and pitfalls included:
- Know exactly what you’re creating – digital asset, mobile app, mobile medical app, website or medical device. Knowing what you’re creating in the beginning will allow you to put the right project parameters in place from the start.
- Developers are often tiny firms – pharmaceutical companies are not accustom to dealing with smaller firms who may only consist of a few people.
- Know the regulations.
- Are you creating a mobile medical app? The FDA issued new guidance’s in February 2015 addressing Mobile Medical Applications.
- What region will your app be used in? Regulations are different depending on what part of the world the app will be servicing.
- Users are not controllable! Implement processes to recall an application if necessary or restrict access when needed.
- Usability of the app – consider the functionality, appearance, navigation, language, etc.
- Know when to get regulators involved! This is very important depending on what kind of app you’re creating. For example, there are different guidelines for creating a mobile app versus a mobile device.
Randy Perez stated many of the challenges mentioned above need to be considered in the design state of the app versus waiting until the testing or launch phase. Planning ahead can save you thousands and thousands of dollars and sleepless nights.
There are many factors that need to be considered when launching a mobile app – and this discussion just skims the surface. Before you kick off an initiative this big, check out the GAMP® A Risk-Based Approach to Regulated Mobile Applications guidance document. This document can help guide you from start to finish with over 80 pages packed full of information and case studies.