--- 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 ML Michael L. Facilities Manager Small-Business (50 or fewer emp.) 5/5/2025 "Greenlight Guru works great for us!" 5/5 What do you like best about Greenlight Guru Quality Management System? Greenlight Guru has proved to be easy to use, with top-tier support and great compliance features. The Quality Processes and Products modules have been especially useful during our project—it makes managing CAPAs, complaints, audits and trace matrices super streamlined and traceable. While it is not highly customizable, it’s a reliable system for staying compliant and organized. Yet, feedback for future features is always welcomed by the support team. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Nothing to write about here. All good things to say. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Proper organization, including documentation routing and ease of flow. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerSource: Organic CT Chris T. Sr. Regulatory Affairs Specialist and Management Representative. Small-Business (50 or fewer emp.) 8/21/2024 "It is a complete system that is easy to use and works for everyone." 5/5 What do you like best about Greenlight Guru Quality Management System? It covers nearly the entirety of the QMS from document and change control, design controls, risk management, and monitoring and improvement processes. The interface is simple to learn and the automation function allow one to tailor the system to their own procedures. The GG team guided us in the implementation of the different modules and helped in providing work instructions that could be tailored to comply with internal requirements. It is often the first application I open every morning. The validation packages are simple to integrate into our own QMS requirements and the module training videos made it easy for the employees to learn to use the system. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? It would be very helpful if the system were available in other languages. At the moment it is English only which works for American customers, but becomes tricky for international companies. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? I'm really pleased to learn that the notifications function will be modified to be more pertinent to the user. The system is constantly improving and the feedback given is considered in future development. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite SS Somesh S. Quality Engineer Small-Business (50 or fewer emp.) 8/15/2024 "Does what you expect of an eQMS, but VERY well" 4.5/5 What do you like best about Greenlight Guru Quality Management System? Greenlight Guru provides a simple and consistent approach to QMS. It is elegantly presented, simple to use and very intuative. Also, the fact that Greenlight Guru has limited configuration makes it very easy to use - the important thing to remember is that YOU have to adapt YOUR practices to get the best out of Greenlight Guru. Greenlight Guru is very simple to implement, but users have to commit to using Greenlight Guru. Customer support and help with using Greenlight Guru is pretty amazing. The online videos are very helpful to refer back, and live support is also pretty good. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? There are some inconsistencies within Greenlight guru workspaces. As an example, some field enties require the user to save, but other do not, some work spaces use RTF text boxes, but other workspaces do not (e.g. Risk Management vs Change Orders respectively). Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Allowing all documentation to be controlled in one location and the ease of croos-referencing. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerSource: Seller invite BA Brandon A. Quality Assurance Manager Small-Business (50 or fewer emp.) 8/14/2024 "One of the best QMS out there!" 4.5/5 What do you like best about Greenlight Guru Quality Management System? Very user friendly. Not much configuration and coded automations needed to setup and use. Aesthetically pleasing, nice built in analyitics. The University, feedback, and support systems are amazing...especially the instant Chat. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? The pro of not much configuration and coded automations is also a bit of a con, wish there were some things you could configure on your own or set up in the background like poke-yoked document numbering or different Risk configurations. But really other than that can't complain about anything at all and really like the system....glad we went with GG! Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Obviously the compliance aspect of a med device QMS. Everything is built to suffice 13485 and not much thinking on our part to remember something in an investigation or change evaluation. All the info is built in and required to complete. We also got the document package, with an entire med device QMS document set that are all written to 13485, FDA, 62304, MDD, and MDR compliance!!! Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerSource: Seller invite TW Terris W. eQMS Specialist Mid-Market (51-1000 emp.) 2/14/2024 "Greenlight Guru's customer support is top-of-the-line." 4.5/5 What do you like best about Greenlight Guru Quality Management System? Greenlight Guru is straightforward to use, while also allowing enough flexibility to make the QMS fit our existing processes. The customer support team at Greenlight is incredible, and we've even been included in conversations regarding new functionality to identify what is important to our organization. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? Greenlight Guru QMS could use some more improvements to help out the larger organizations who use the software. Some improvements have been made (the training has recieved a total makeover, for example!), but the ability to "mass-edit" things would be a big time saver. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Our previous QMS operated out of Excel files and word documents, so Greenlight is completely revolutionary to us. The biggest problem it solved was training, as our previous system was very manual, disjointed, and required massive amounts of manpower to train over 1200 employees. On top of that, it took a lot of digging into individual training files to know who was trained on what. Greenlight's training workspace solves all of us this, and the training status API export gives us the visibility we've always needed. Review collected by and hosted on G2.com. Show More 8/14/2024 Current UserValidated ReviewerIncentivizedSource: Seller invite ![Devin W.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Devin W.") DW Devin W. Quality Specialist Mid-Market (51-1000 emp.) 8/13/2024 "Greenlight Guru: An Intuitive and User Focused Experience" 4.5/5 What do you like best about Greenlight Guru Quality Management System? Greenlight Guru offers a Quality Management System that is very user focused and easy to use. The dashboard offers updates and tasks assigned to each user, making for a customer friendly and intuitive user experience. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? The onboarding experience is a bit combersome because of the process of adding legacy documents into the system. This process takes a little while to complete when first getting used to the interface , but once completed, everything is loaded into the eQMS and ready to view. It would be easier if there was a mass data upload available, instead of loading in batches. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Greenlight Guru offers a eQMS that stores all of our original documents to be compliant with FDA regulations. This has been exceptionally helpful when addressing Customer Feedback and complaints. This program has helped us coordinate with our partners in China on resolving complaint issues. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerSource: Organic ![Verified User in Medical Devices](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User in Medical Devices") UM Verified User in Medical Devices Small-Business (50 or fewer emp.) 8/21/2024 "Greenlight Guru for Wound Dressing Company" 4/5 What do you like best about Greenlight Guru Quality Management System? Our company made the switch to Greenlight Guru over two years ago after being fully pape-based. Greenlight Guru makes the document control and change order processes very simple and easy to follow! The recent updates made to automate the Training Workspace have proven to work and was easy to integrate into our processes. The Greenlight Guru team is also always responsive and helpful with any software or industry-related questions. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? The Audit Workspace is very separated from the CAPA Workspace. Findings and corrective actions as the result of an audit are embedded into the Audit Workspace. Our CAPA Workspace, therefore, is not a clear indication of how many Corrective and Preventive Actions we have taken. Integrating the two workspaces would be beneficial on an auditing standpoint. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Greenlight Guru makes it easy for us to conduct our day-to-day quality business. Also, during our quality surveillance audits, Greenlight Guru makes it easy to download records of change orders and audit reports, as a couple examples. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite ![Bryson B.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Bryson B.") BB Bryson B. Project Manager Small-Business (50 or fewer emp.) 5/28/2024 "Must-Have for Modern Medical Device Companies" 5/5 What do you like best about Greenlight Guru Quality Management System? Greenlight Guru has been a game changer for my company. We transitioned from a paper-based QMS to Greenlight Guru and our productivity has increased tremendously. It is a one-stop shop for all of our QMS needs: From Design Controls, to Risk Management, to Document and Change Management, to CAPA & Nonconformance management & so on. On top of this, their customer support is unmatched. Their in-house team of experts have a very quick response time, and if they don't have an answer off the top of their head, they will work with you to find it! 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 Guru. Most of my "negative" feedback is around features that are not yet present in the software. Having a Supplier workspace to automatically create an ASL, link documents, etc would be very helpful for our company. I know this and many other features are currently under consideration, so Greenlight is always soliciting customer feedback to improve their product. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? One area (among many) that it is solving document/change management, which was a big problem area for us prior to GG. GG has created a single source-of-truth for up-to-date documents and is now the first place that employees go to access the latest versions and manage new document updates. Another area it has helped tremendousely with is Design Controls. Prior to GG we were using a variety of excel spreadsheets, which caused us to not really know what our most up to date list of design control items were and we were not doing a formal design review process. Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite ![Stephen L.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Stephen L.") SL Stephen L. QA/RA Manager Small-Business (50 or fewer emp.) 5/21/2024 "Well structured platform" 5/5 What do you like best about Greenlight Guru Quality Management System? The most helpful part of using Greenlight Guru is the layout and structure of the user platform. Everything is on your home page where you can see current open change orders, complaints / feedback, nonconformities, reviews, actions etc. The user interface is extremelly helpful, and having access to system gurus is great when you have any industry related questions that you need help with. The support and training that comes with Greenlight Guru is second to none, there is a whole database with articles, videos, and demostrations. The system is built for the future of quality management. The use of Greenlightguru has streamiled my processes, audits are completed quicker, and we had no findings or observations during our last NB audit. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? The only downside i see is that you have to enter your password too many times, i know i could save the password to autfill on google chrome but i dont like that. Maybe an option for when you log in you can creat a 4-6 digit PIN would be easier. Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? Using the system has greatly reduced the amount of paper / waste we produce by running a paper-based QMS. Processes have been streamlined, tracking the daily QMS activities and events are eaasyily acheived due to user interface Review collected by and hosted on G2.com. Show More Current UserValidated ReviewerIncentivizedSource: Seller invite ZM Zach M. Small-Business (50 or fewer emp.) 5/14/2024 "Extremely useful, could be more customizable." 4.5/5 What do you like best about Greenlight Guru Quality Management System? Migrating from a paper-based system to an eQMS can be daunting, with the sheer number of documents and changes. Greenlight Guru was incredibly helpful in facilitating implementation of the software, including uploading several hundred documents for us. Change Orders and Nonconformances are much faster and more streamlined, allowing the Quality department to operate at an efficiency that would never have been possible with a paper system. Review collected by and hosted on G2.com. What do you dislike about Greenlight Guru Quality Management System? While the software is great, it could stand to be more customizable. While I appreciate it being tailored specifically for ISO 13485, it is also geared more towards OEM companies. We are more of a "job shop" in that we receive and process parts - we do not have any products of our own. Therefore the "Products", "Projects", and "Customer Feedback" modules are not usable for us. Additionally, the Nonconformance space has a lot of options and functions for companies with specific products - we have to sort of make it work for us ("nonconformance type" and "investigation category" don't really have options that make sense in our context). Review collected by and hosted on G2.com. What problems is Greenlight Guru Quality Management System solving and how is that benefiting you? With a paper-based eQMS, it was very difficult to control Document Revisions, as people would have paper copies around the building (as well as copies saved to their computers). Now with everyone retrieving their documents through Greenlight Guru, we have a lot more control. Also, getting everybody to sign off on DCOs and NCs was a pain, now they just recieve an email notification and take care of it in moments. Review collected by and hosted on G2.com. Show More Current UserValidated 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) 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) ![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) [ 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(463) [ 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 [Which vendor provides the most advanced data quality management tools?](https://www.g2.com/discussions/which-vendor-provides-the-most-advanced-data-quality-management-tools)[Which museum management solutions do teams actually adopt and continue using long-term?](https://www.g2.com/discussions/which-museum-management-solutions-do-teams-actually-adopt-and-continue-using-long-term)[Best payroll software for small business](https://www.g2.com/discussions/best-payroll-software-for-small-business) [Ecwid vs PrestaShop for a small online store: which is easier to set up and grow with?](https://www.g2.com/discussions/ecwid-vs-prestashop-for-a-small-online-store-which-is-easier-to-set-up-and-grow-with)[What's the most recommended customer success platform for SaaS companies](https://www.g2.com/discussions/what-s-the-most-recommended-customer-success-platform-for-saas-companies)[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);)