November 11, 2013

Improving Visibility into Risk Controls with TestTrack

Helix ALM
Requirements Management
In our recently completed 2013 State of Medical Device Development Survey we asked medical device professionals, "What are the top three pieces of information or insights you wish you had better visibility into during the design control phase?" The most common response? Risk controls! If you look at the responses to another question we asked about how teams are managing their risk artifacts, you won't be surprised that folks are struggling with visibility into those artifacts. Almost 90% of teams are using documents to manage risk identification, analysis, and mitigation.

Tools for Risk Identification and Mitigation

Gaining visibility into a Word document is challenging! Assuming the "latest copy" is easily accessible, which is not often true in my experience, actually understanding what's in the document requires digging into the contents of that document to find the relevant information. To improve visibility, you need to get those assets out of Microsoft Word and begin managing them as individual artifacts. With risks broken out and managed individually, it's much easier to track down an individual artifact, review progress, and investigate related tasks and work items. If you're still not convinced, read this short three-page white paper on the benefits of exposing product risk throughout the development cycle By moving from documents to a tool like TestTrack, you can realize these benefits. TestTrack gives you the ability to trace all related requirements, tasks, verification tests, and issues from a single risk mitigation requirement. Watch the following video for a quick look at how this works in TestTrack http://youtu.be/KE-eisUTXag