August 3, 2011

Video: Reporting and Submission Made Easier with TestTrack

Helix ALM
When it comes time to submit required paperwork to the FDA for an audit or product submission, it’s important to use an electronic data management system to ensure your reports are completed promptly, professionally, and in compliance with all FDA requirements. The FDA dictates that your submissions must include a description of device design, how the design was implemented and tested, proof that risks and hazards were identified and handled appropriately, and ultimately provide clear traceability, all of which can require days or even weeks of effort to compile manually. The right electronic data management system will collect and archive that information and decisions in real-time as the project is in progress. At submission time, it’s just a matter of running a few reports and you’re ready to take that big step in seeking approval to get your product to market. To read more about submissions requirements, check out the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Following are some of the benefits of using TestTrack for your medical device product development practices:
  • Requirement changes are updated in real time
  • The traceability matrix  can be generated and printed in minutes
  • Audit trail available for viewing, which is useful for unexpected FDA audits
  • Preconfigured reports for testing and validation are available right out of the box
To learn more about improving your development practices with TestTrack, watch the following video and download our How to Have a Painless FDA Audit white paper. You can also schedule a private demonstration to learn more about TestTrack for life sciences organizations and to discuss your team’s needs.