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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. |
Avoid the rework and excess documentation involved with each new quality event opened, by implementing custom CAPA, Nonconformance, Customer Feedback, or Audit workflows to automate the step-by-step process.
Increase your team’s efficiency when managing post-market quality events with custom-built, automated workflows while still working within the guardrails of Greenlight Guru.
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.
An efficient and controlled way of managing our documentation is now much more straightforward. I am confident that we are compliant with using GG
Greenlight Guru are ahead of the game in terms of incorporating workflows which lead to compliance to ISO 13485:2016 and 21 CFR Part 820 regulations. The Change Management and Document Control functionalities make it easy to control records and document approvals especially in a world that is moving away from the traditional 'in-office' setting to remote working
The software is user-friendly and customizable enough to meet your needs if you already have an existing QMS set up. But honestly, the best part is the team we work with for our transition process. They make the difference in this being a good experience. Their friendliness and wealth of knowledge about the medical device industry made the process so easy
With Greenlight Guru, we have been able to solve training gaps, on-time completion of customer complaints and non-conformances, and change orders. Previously to Greenlight, we had complaints that sat uncompleted for over a year; now with GG we are able to close them in less than 30 days.
Greenlight Guru is life-changing! The platforms for documentation and collaboration have made me and my team so much more efficient. It has turned the huge headache of regulatory compliance into a much more manageable task.
Fantastic support, complete documentation package which just needs minor adjustments to suit the company, intuitive navigation through the menu, and different QMS modules inside the software.