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Functionality enhances security while maintaining visibility and transparency in medical device quality management
INDIANAPOLIS — September 5, 2018 — Greenlight Guru, the only quality management software designed specifically for medical device companies, announces Advanced Document Management, the latest version of its purpose-built software.
Advanced Document Management enables collaborative sharing amongst teams while maintaining appropriate security levels through the use of its robust permissions feature. These granular controls give teams from small, midsize and enterprise organizations greater flexibility in assuring the right people have access to the right documents in real time. Advanced Document Management is built to scale, allowing documents to be shared with individuals, roles or geographic teams. The latest release also includes an enhanced user interface for more dynamic and intuitive document lists, including filtering by document classification or workflow routing statuses.
“We set out to make the lives of patients better as well as the lives of those designing the next generation of medical devices,” says Greenlight Guru co-founder and CEO David DeRam. “Keeping documents, records and procedures secure, up-to-date and always accessible in a spreadsheet or paper-based system is a never-ending task that often leads to mistakes and the inevitable question, ‘which version of the document is most up-to-date?’. Advanced Document Management ensures documents are secured and access is properly controlled across the entire organization in minutes, not hours.”
The medical device industry surpassed more than $370 billion in sales in 2017; however, concurrent to this growth is the rise in adverse events resulting in patient death and injuries, as well as product recalls. According to the FDA’s Medical Device Recalls database, July 2018 saw more than 296 medical device recalls.
The U.S. Food and Drug Administration is partnering with medical device industry stakeholders – including Greenlight Guru – to develop a mindset of quality rather than compliance-only. Tools such as Advanced Document Management reduce the administrative load associated with maintaining compliance and allow device makers to focus on developing high-quality devices.
“Errors in document management is a common source of delay in device reviews and approvals,” says Greenlight Guru founder and VP of QA/RA Jon Speer. “This update will allow product managers to assign documents to the relevant teams – and no one else – thereby keeping workflows free of documents that aren’t relevant to that team’s function. Additionally, our new document sorting and filtering capabilities will reduce the time needed to locate and produce documents for approvals and audits, allowing manufacturers to focus less on paperwork and more on creating quality medical devices.”
This product update follows Greenlight Guru’s Multi-Level Design Controls update and partnership with the FDA to provide meaningful insight into the FDA’s Case for Quality Initiative. For a demo of the new Advanced Document Management feature set with a medical device guru, please visit https://www.greenlight.guru/quality-management-software-demo.
Greenlight Guru is the only quality management software platform designed specifically for medical devices companies. This unique platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes, such as CAPAs, risk, audits and more. Greenlight Guru’s software solution is used by thousands of users across the globe, allowing teams to push beyond baseline compliance and achieve True Quality.
Nick Tippmann is an experienced marketing professional lauded by colleagues, peers, and medical device professionals alike for his strategic contributions to Greenlight Guru from the time of the company’s inception. Previous to Greenlight Guru, he co-founded and led a media and event production company that was later...