--- title: Greenlight Guru Quality Management System Reviews meta\_title: 'Greenlight Guru Quality Management System Reviews 2026: Details, Pricing, & Features | G2' meta\_description: Filter 411 reviews by the users' company size, role or industry to find out how Greenlight Guru Quality Management System works for a business like yours. aggregate\_rating: rating\_value: 4.5 review\_count: 411 scale: '5' date\_modified: '2026-08-09' parent\_category: name: Environmental, Quality and Safety Management url: https://www.g2.com/categories/environmental-quality-and-safety-management --- # Greenlight Guru Quality Management System Reviews & Product Details Visit Website Greenlight Guru is the #1 quality management system built exclusively for medical device companies. Not life sciences. Not pharma with a medtech configuration layer. Because we built exclusively for medical devices, ISO 13485, ISO 14971, and FDA QMSR aren't frameworks you configure after the fact. They're the foundation. Most quality teams manage compliance across systems that were never designed to talk to each other. A document control tool here, a spreadsheet for CAPAs there, a separate process for change control. In a regulated environment, that gap doesn't stay invisible, it shows up during audits. Greenlight Guru gives Quality and Product teams a single connected system where document control, training, CAPA, nonconformance, change control, supplier management, risk management, and design controls work together. When a change happens, it flows through the workflow. Meaning limited manual handoffs, and nothing falling through the cracks between teams. For Quality and Regulatory Affairs professionals, that means audit-ready workflows with automated routing, electronic signatures, and complete audit trails built in, including end-to-end traceability across design controls. No more chasing approvals or manually tracking compliance status. Teams that run on Greenlight Guru are 3.5x less likely to receive a major audit finding. For R&D and product teams, it means staying in the tools they already use, with changes automatically syncing to design controls so documentation builds itself as you work, not after the fact as a separate project. Greenlight Guru AI handles the repetitive work that slows teams down, and it was built with 15 years of medtech context behind it, not bolted on from a general-purpose model. AI-powered search finds answers across your QMS instantly. Chat analyzes system data to surface insights. Auto-generated summaries give immediate context on documents, suppliers, and quality events. For product teams, verifiability checks catch vague requirements before they become audit findings, suggested links close traceability gaps automatically, and AI brainstorming gets engineers moving faster. For quality teams, AI generates training quizzes and drafts change order summaries, so your team spends less time writing and more time on the work that actually requires their expertise. The platform is validated out of the box and aligned to FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and FDA 21 CFR Part 11. Implementation is measured in weeks, not the quarters-long projects that come with legacy enterprise platforms. Backed by 80+ audit-tested, customizable templates and a team of experts who know medtech inside and out. You're not managing a separate validation project before you can go live. For 15 years and across more than 1,000 device companies worldwide, Greenlight Guru has been the QMS medical device teams trust to pass audits, bring products to market, and stay on the market longer. * * * Product Website Greenlight Guru Quality Management System Seller [Greenlight Guru](https://www.g2.com/sellers/greenlight-guru) Discussions [Greenlight Guru Quality Management System Community](https://www.g2.com/products/greenlight-guru-quality-management-system/discuss) Languages Supported English Solution Type Best-of-Breed Show More ## Value at a Glance Averages based on real user reviews. ### Time to Implement 3 months [ View More Pricing Information ](https://www.g2.com/products/greenlight-guru-quality-management-system/pricing) ## Greenlight Guru Quality Management System Integrations (4) What do users say about integrations? Verified by Greenlight Guru Quality Management System [ ![Product Avatar Image](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Product Avatar Image") GitHub ](https://www.g2.com/products/github/reviews)[ ![Product Avatar Image](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Product Avatar Image") Google ](https://www.g2.com/products/google-google/reviews)[ ![Product Avatar Image](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Product Avatar Image") Jira ](https://www.g2.com/products/jira/reviews)[ ![Product Avatar Image](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Product Avatar Image") Microsoft 365 ](https://www.g2.com/products/microsoft365/reviews) Show More ![Daniel P.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Daniel P.") DP Daniel P. Advisor Medical Devices Small-Business (50 or fewer emp.) 2/1/2019 "5 Years of Greenlight Guru, still loving it." 5/5 What do you like best about Greenlight Guru Quality Management System? I really like having all the components of the QMS centralized in one tool. In the past I've worked for companies where each part of the QMS was its own system with its own login, rules, nuances, etc. UPDATE: GG is an integral part of the business and just continues to add value. I've never once had the quality team complain or grumble - the software just does what we need it to do. Recently did a mock audit and pulling all the requested documents was fast and easy. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Needs a button to "poke" everyone to sign their document - people get busy and the project manager needs to have a quick way to remind them. Review collected by and hosted on G2.com. Recommendations to others considering Greenlight Guru Quality Management System: The cost of implementing a manual system will far exceed the cost of buying a validated system. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? As a startup, this system removed countless hours of authoring SOPs and implementing work instructions for basic things like document sign offs and storage. Review collected by and hosted on G2.com. Show More 2/9/2024 Validated ReviewerSource: Organic ![Joe-Louis Y.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Joe-Louis Y.") JY Joe-Louis Y. Safeguard Biosystems Corp Small-Business (50 or fewer emp.) 5/21/2024 "Seamless and Very Efficient QMS." 5/5 What do you like best about Greenlight Guru Quality Management System? Ease of implementation and us. The wealth of quality information is very useful and the seminars they provide are very informative. Customer support is also excellent. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Some features require some diging to find. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? It has solved our document control process, management of our bill of materials and training on documents. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite ![Erjan Leroy N.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Erjan Leroy N.") EN Erjan Leroy N. Music producer, singer, keyboardist Small-Business (50 or fewer emp.) 5/21/2024 "Extremely helpful tool for document management" 5/5 What do you like best about Greenlight Guru Quality Management System? To be able to refer to Greenlight Guru for instructions at any time while working is very convenient way for efficient work. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? I like the system very much, I can not say anything negative Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? I can get the products' specifications and work instructions easily and this helps me work efficiently Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite JM June M. Small-Business (50 or fewer emp.) 3/4/2024 "Great product and great customer service" 4.5/5 What do you like best about Greenlight Guru Quality Management System? A validated system, with all the relevant processes and pro-formas - regulalry updated when standards or regulatory requirements are updated. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? When implimenting the GG eQMS for the first time, a little background knowledge on the process and additional modules (such as the training module) is essential. Lack of knowledge of new entrants can cause some delays and uncertainty in how to proceed. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Preparation for a small start-up - to submit their first product to the regulatory authorities. Provision of the relevant pro-formas, Work Instructions, SOPs, etc. is invaluable. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite ![Verified User in Medical Devices](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User in Medical Devices") AM Verified User in Medical Devices Mid-Market (51-1000 emp.) 5/16/2024 "Best in class eQMS" 4.5/5 What do you like best about Greenlight Guru Quality Management System? The best thing that I like about Greenlight Guru is that it was designed and is continuously improved by actual medical device quality professionals. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? There is not much that I dislike about greenlight. If I had to nitpick...the feedback I get most often is users have a hard time understanding the difference between the search bar on the dashboard vs. the one that is in each module. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? GG allows us to have a fully validated eQMS that is compliant in the medical device space. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite ![Jaribu S.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Jaribu S.") JS Jaribu S. Small-Business (50 or fewer emp.) 5/14/2024 "My company used Greenlight Guru as a QMS for important documents and protocols." 4.5/5 What do you like best about Greenlight Guru Quality Management System? I love the security. My company's assets feel safe with Greenlight Guru. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? The timeouts!Sometimes I don't like that it times out so fast. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? I think it solved organization for my compoany. Everything is now in a secure place. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite ![Verified User in Medical Devices](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User in Medical Devices") UM Verified User in Medical Devices Mid-Market (51-1000 emp.) 3/4/2024 "Easy to use and effective program" 4.5/5 What do you like best about Greenlight Guru Quality Management System? Greenlight Guru is intuitive in its use and is effective in ensuring that employees have fully understood the policies and proper procedures Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? While I appreciate receiving reminders for incomplete tasks, it's important to note that if there is no activity on my Greenlight Guro account for 30 days, the system automatically marks my account as inactive. To prevent deactivation, I must make sure to log in periodically, especially if no tasks have been assigned during this time frame. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Ensuring that policies and procedures are properly understood and followed by all employees of the company to ensure that we are compliant. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite MM Melinda M. Medical Laboratory Technologist Mid-Market (51-1000 emp.) 5/28/2024 "Easy to navigate" 5/5 What do you like best about Greenlight Guru Quality Management System? It's very user friendly and easy to navigate. Tasks that need to be completed are clearly accessible and anotated so the users can see what need to be done. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? The need to keep putting in your log in information when completing multiple training modules. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? The need to complete training modules in a timely manner has vastly improved. Review collected by and hosted on G2.com. Show More Validated ReviewerIncentivizedSource: Seller invite ![Robyn P.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Robyn P.") RP Robyn P. Small-Business (50 or fewer emp.) 2/15/2024 "Wonderful Service from Brittani" 5/5 What do you like best about Greenlight Guru Quality Management System? Knowing that this system is alligned to ISO standards allows us to move forward woth confidence. The impletation while complex was smooth thanks to our guru. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? I didn't persoanlly like using the sandbox as I didn't find it helpful, but I am sure many people do. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? GG is filing an unmet need for our company, we currently have no QSM and now we confifdently have one that is ISO appropriate. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite ![Brian F.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Brian F.") BF Brian F. Small-Business (50 or fewer emp.) 5/20/2024 "I like GLG but I think the organization of some of the drop down menus could be expanded a bit more." 4/5 What do you like best about Greenlight Guru Quality Management System? I love that it houses all information and that it has the ability to store alot of information. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? When in training, it should prompt a "complete" option / window. I've finished trainings forgetting to scroll at the bottom to click confirm. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Orgaization and documentation. We have a lot of documents needing a lot of eyes on them for approval. Review collected by and hosted on G2.com. Show More Validated ReviewerIncentivizedSource: Seller invite ## Questions about Greenlight Guru Quality Management System? Ask real users or explore answers from the community Get practical answers, real workflows, and honest pros and cons from the G2 community or share your insights. [ Ask about Greenlight Guru Quality Management System ](https://www.g2.com/products/greenlight-guru-quality-management-system/discussions/new) ![Verified User](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User") G2 Verified User • Last activity over 6 years ago Can my medical device company benefit from using Greenlight Guru’s software if we are based outside the US or intend to sell our devices into international markets? 2 Upvotes 1 [ Join the conversation ](https://www.g2.com/discussions/markets-served) JK Jeroen Kruijer • Last activity over 4 years ago When do you think a planning tool/Calender can be incorporated in Greenlight Guru? 2 Upvotes 1 [ Join the conversation ](https://www.g2.com/discussions/when-do-you-think-a-planning-tool-calender-can-be-incorporated-in-greenlight-guru) [ View all Discussions ](https://www.g2.com/products/greenlight-guru-quality-management-system/discuss) ## Pricing Insights Averages based on real user reviews. ### Time to Implement 3 months ### Return on Investment 22 months ### Average Discount 12% [ View More Pricing Information ](https://www.g2.com/products/greenlight-guru-quality-management-system/pricing) Greenlight Guru Quality Management System Comparisons ![Product Avatar Image](https://images.g2crowd.com/uploads/product/image/small_square/small_square_239fdb020d69919db5553a9bf0b0e605/qualio.jpg "Product Avatar Image") Qualio 4.4/5(781) [ Compare Now ](https://www.g2.com/compare/greenlight-guru-quality-management-system-vs-qualio) ![Product Avatar Image](https://images.g2crowd.com/uploads/product/image/small_square/small_square_952e9aa4df0af1b0706297e2afcb725f/mastercontrol-quality-management-system.png "Product Avatar Image") MasterControl 4.3/5(528) [ Compare Now ](https://www.g2.com/compare/greenlight-guru-quality-management-system-vs-mastercontrol-quality-management-system) ![Product Avatar Image](https://images.g2crowd.com/uploads/product/image/small_square/small_square_62ce07a97b655c6f93cfa06af1edb429/arena-plm-qms.png "Product Avatar Image") Arena PLM & QMS 4.2/5(464) [ Compare Now ](https://www.g2.com/compare/arena-plm-qms-vs-greenlight-guru-quality-management-system) ##### ##### Greenlight Guru Quality Management System Features Quality Management Design Controls Risk Management Quality System Real-time Collaboration Document Control Nonconformance Conformance Records CAPA Change Management Quality system Document Control Collaboration Analytics and Reports [ View More Features ](https://www.g2.com/products/greenlight-guru-quality-management-system/features) ## Top-Rated Alternatives [ ![Qualio](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Qualio") Qualio 4.4/5(781) ](https://www.g2.com/products/qualio/reviews) [ ![Octave Reliance (ETQ Reliance)](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Octave Reliance (ETQ Reliance)") Octave Reliance (ETQ Reliance) 4.3/5(624) ](https://www.g2.com/products/octave-reliance-etq-reliance/reviews) [ ![MasterControl Quality Management System](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "MasterControl Quality Management System") MasterControl Quality Management System 4.3/5(528) ](https://www.g2.com/products/mastercontrol-quality-management-system/reviews) [ View All Alternatives ](https://www.g2.com/products/greenlight-guru-quality-management-system/competitors/alternatives) ##### Categories on G2 [Quality Management (QMS)](https://www.g2.com/categories/quality-management-qms)[Medical QMS](https://www.g2.com/categories/medical-qms) ##### Explore More [Is KeyShot worth the licence cost for product visualization work?](https://www.g2.com/discussions/is-keyshot-worth-the-licence-cost-for-product-visualization-work)[What failover and high availability capabilities should teams evaluate in web server accelerator solutions?](https://www.g2.com/discussions/what-failover-and-high-availability-capabilities-should-teams-evaluate-in-web-server-accelerator-solutions)[Best Remote Desktop Software](https://www.g2.com/discussions/in-your-opinion-what-is-the-best-remote-desktop-software) [Best platforms for integrating PM with estimating tools](https://www.g2.com/discussions/best-platforms-for-integrating-pm-with-estimating-tools)[Which application release orchestration tools give an engineering team full audit trails and compliance reporting for releases so regulated industries can pass deployment audits?](https://www.g2.com/discussions/which-application-release-orchestration-tools-give-an-engineering-team-full-audit-trails-and-compliance-reporting-for-releases-so-regulated-industries-can-pass-deployment-audits)[Pros and Cons Details](https://www.g2.com/products/greenlight-guru-quality-management-system/reviews?qs=pros-and-cons) [Show MoreShow Less](javascript:void(0);)