Greenlight Guru Launches Tool to Support Closed-Loop Traceability

Greenlight Guru, a medical device quality management software platform, launched Visualize to help medical device manufacturers with their approach to closed-loop traceability.

Visualize provides an alternative for reliance on tribal knowledge and manual processes across disconnected, siloed systems to understand the connective tissue of traceability that holds their quality system together. Instead, users can achieve closed-loop traceability through a fully connected quality ecosystem.

Machine learning capabilities allow device companies to see, understand and interact with the relationships and connectedness of their quality system. This allows for a proactive, data-driven approach that improves accuracy and efficiency of all decisions made throughout the medical device life cycle.

These machine learning (ML)-driven capabilities include:

  • ML-powered relationship creation and virtual linking of all related items within the QMS
  • A visual traceability pop-up map accessible on-demand to show all linked or related items and where used
  • Transparency into the bridging of relationships between items in the QMS, along with the type and directional relationship of the connected items
  • The ability to navigate deeper into the related items to see where else they are used in the QMS
  • Multi-tiered filtering capabilities to customize the user’s view of QMS data most relevant to the user’s search

“Today, 45% of medical device professionals cannot demonstrate closed-loop traceability in their quality system, and of those that are able to, one in three still say it takes substantial effort to do so, which is astonishing considering the implications. Visualize allows medical device professionals to eliminate human error, uncover the downstream impacts of change, gain full visibility into quality data trends, and reduce the cost of poor quality by making better quality-driven decisions,” said David DeRam, CEO of Greenlight Guru.

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