According to a recent press release, “Greenlight Guru, quality management system purpose-built for medical device companies, today announced new updates to the platform’s Change Management capabilities. The enhanced Change Management capabilities include advanced workflow efficiencies in customers’ ability to identify, assess, and track the items impacted by change orders in a collaborative change workspace, while also ensuring connectivity and traceability to any records or sources that influenced design or process changes within the quality ecosystem. Additionally, customers can now track and trend the effectiveness of their change activities with analytics & KPI’s. Issues associated with medical device changes, both process- and product-related, represent a significant source of noncompliance for medical device manufacturers. Changes require updated documentation, approvals and signatures across teams, and depending on the complexity of the device across multiple departments, as well as clearly stated justification and desired outcomes for each change.”

The release continues, “Whether it be design changes that require updates to design controls and risk matrices, or document changes that impact multiple procedures, work instructions, or forms, Greenlight Guru’s Change Management functionality ensures medical device companies a simple way to manage change and be audit-ready. ‘Paper and digital-paper based systems, such as spreadsheets and file hosting sites, can only get you so far once serious changes start being made to a medical device,’ said Jon Speer, founder and VP of QA/RA at Greenlight Guru. ‘Quality management systems shouldn’t get in the way of innovation; we’ve improved our change management capabilities to make high device quality possible through the QMS, not in spite of it’.”

Read more at PR Web.

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