What To Know
- Over time, as the complexity of the company's quality system grows, this often leads to enormous personal stress for those managing the system, productivity loss for everyone involved, and worst of all, increases the likelihood of regulatory problems and recalls for the company.
- “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.
September 21, 2020
Greenlight Guru, the leading medical device quality management software (MDQMS) platform, today announced the launch of Visualize, redefining the way medical device manufacturers approach closed-loop traceability. With the launch of Visualize, Greenlight Guru continues its mission to help medical device companies move beyond baseline compliance and achieve True Quality.
Today, medical device professionals need to rely on tribal knowledge and manual processes across disconnected, silo’d systems to understand the connective-tissue of traceability that holds their quality system together. Over time, as the complexity of the company’s quality system grows, this often leads to enormous personal stress for those managing the system, productivity loss for everyone involved, and worst of all, increases the likelihood of regulatory problems and recalls for the company.
Greenlight Guru Visualize provides a platform for users to achieve closed-loop traceability through a fully connected quality ecosystem. The machine learning capabilities allow medical device companies to see, understand, and interact with the relationships and connectedness of their quality system in a way that was previously impossible. This promotes a shift in focus from reactive, manual quality management to a proactive, data-driven approach that improves the accuracy and efficiency of all decisions made throughout the medical device life cycle.
“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. “Visualize is a new paradigm in how you see, explore, understand, and communicate the world of quality — and it’s only the beginning.”
Visualize redefines how the medical device industry can think about quality systems and how these systems are managed to ensure True Quality. By connecting data, Visualize creates a reliable and efficient approach to managing quality and overall system traceability. These machine learning (ML) driven capabilities are now available to Greenlight Guru customers:
- 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
“There are so many inputs, outputs, independent and interdependent activities, that the ability to achieve transparency and visibility into the relationships within our QMS is invaluable,” says Morris Sherwood, Person Responsible for Regulatory Compliance at Zyris Dental and Greenlight Guru customer. “Visualize gives me that picture and allows me to be more successful, more effectively communicate this world to my colleagues, and provides a way to process quality information more expeditiously. ”