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It's the leading QMS designed specifically for the medical device industry, enabling a new way to manage your quality program. |
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Track and manage quality events and associated follow up tasks digitally. |
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Capture usable quality metrics in real-time. |
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Assure your team's documentation is audit ready in real time. |
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Drive traceability throughout your quality, design, and risk processes. |
Enable a culture of quality by managing quality events like CAPA, Customer Feedback, and Audits in Workspaces with 21 CFR Part 11 compliant review and approval workflows to collaborate with internal and external stakeholders
See how teams are streamlining quality processes →
Easily incorporate ISO 14971:2019 compliant risk-based controls into your quality and design processes throughout both development and post-market surveillance stages.
Assure traceability throughout the product lifecycle by easily linking post market activities to Design Controls, Risks, and Documents
Speed up reviews and approvals by keeping your documents, records, and procedures organized, up-to-date and always accessible to the right people with robust sharing and role based security.
See Advanced Document Management in action →
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G2 Crowd provides real-time and unbiased user reviews to help you objectively assess what software is best for your business.
We searched for a digital solution to see if one was available after being told that only paper-based systems would satisfy FDA. We found Greenlight Guru and have been delighted with both the product and the service. Greenligh Guru gives us a digital QMS so that we can safely launch our first four products. We feel confident our system can withstand any FDA audits.
The DC and Risk matrices make Greenlight Guru a great software for medical device companies. The ability to link the design controls and risk elements together allow companies to develop safe and effective devices. The application also allows our teams to work together from different locations in order to accommodate everyone's schedules! The Greenlight Guru software keeps a log of all changes made in the system. This means each time a user views, edits, approves, rejects, etc. an input in the software, the data is captured and can be pulled for reference. This allows for traceability...
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The software allows me to mitigate my regulatory and compliance risk, I have been able to implement a world class eQMS that rivals the largest companies in med device. Greenlight has the best in class support, it is both software and service.
Real time reviewing and publishing of quality documents. GUI of website makes it very easy to navigate without any hassle.
The support at Greenlight Guru has been incredible. There is live chat available and any question [is answered] in a matter of minutes! This extends beyond just how does system support. Greenlight Guru is able to answer questions related to ensuring that your system is compliant to the necessary standards required for medical devices.
Easy to upload, organize, and find documents
