--- 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: '2026-07-17' 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 **Vendor:** Greenlight Guru **Category:** [Quality Management Systems (QMS)](https://www.g2.com/categories/quality-management-qms) **Average Rating:** 4.5/5.0 **Total Reviews:** 411 ## About Greenlight Guru Quality Management System 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. ## Greenlight Guru Quality Management System Pros & Cons **What users like:** - Users find Greenlight Guru's eQMS to be **intuitive and easy to use** , enhancing compliance and streamlining processes. (2 reviews) - Users value the **user-friendly design and robust compliance features** of Greenlight Guru, enhancing their quality management processes. (2 reviews) - Users praise the **effective training tools** of Greenlight Guru, facilitating quick onboarding and compliance with industry standards. (2 reviews) - Users value the **streamlined audit management** features of Greenlight Guru, enhancing compliance and organization effectively. (1 reviews) - Users value the **configurability** of Greenlight Guru, facilitating easy organization and efficient management of quality processes. (1 reviews) - Users praise the **responsive and helpful customer support** of Greenlight Guru, enhancing their overall experience and satisfaction. (1 reviews) - Customizability (1 reviews) - Customization (1 reviews) - Document Control (1 reviews) - Users value the **automatic document version control** and easy accessibility, enhancing efficiency in quality management processes. (1 reviews) **What users dislike:** - Users find the **pricing to be expensive** , which may not be competitive for many teams and adds frustration. (1 reviews) - Users note the **feature limitations** of Greenlight Guru, particularly regarding flexibility and costly extra projects. (1 reviews) - Users find the **current search function inefficient** , suggesting improvements like AI for better information retrieval. (1 reviews) - Users find the **inflexibility of quality events** in Greenlight Guru challenges their workflow despite its adherence to CAPA requirements. (1 reviews) - Users find the **analytics limited** , lacking depth despite offering some useful data insights in Greenlight Guru. (1 reviews) - Poor Search Functionality (1 reviews) ## Greenlight Guru Quality Management System Reviews ### 1. GreenLight Guru Review **Rating:** 4.5/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** June 01, 2021 **What do you like best about Greenlight Guru Quality Management System?** Hands-on training and regular touchpoints with the GLG quality consultants. **What do you dislike about Greenlight Guru Quality Management System?** Nothing that I could think of immediately. **Recommendations to others considering Greenlight Guru Quality Management System:** Start the process very early in the product development process. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Quality management systems organization. We received ISO 13485:2016. ### 2. FlexLogical's review of Greenligt Guru Quality Management software **Rating:** 4.5/5.0 stars **Reviewed by:** Emil C. | Small-Business (50 or fewer emp.) **Reviewed Date:** May 06, 2020 **What do you like best about Greenlight Guru Quality Management System?** It is very easy to manage large amounts of data and have traceability on all of it. Especially during design & development, where many inputs have to be linked to outputs, verification(s) and validation(s). Furthermore, during the risk assessment the inputs and outputs, verifications and/or validations can easily be added as sources and controls to documents risk mitigation. **What do you dislike about Greenlight Guru Quality Management System?** It takes a long time to fill out the design matrix and risk matrix. I think the whole process of this could be optimized, but it is still way better than doing it in an excel sheet! **Recommendations to others considering Greenlight Guru Quality Management System:** If you are a start-up, acquire Greenlight just before you freeze your design, and do also buy greenlights QMS document package to save time and a lot of money. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** We are saving a lot of time because it is so easy to link data to each other, and hence have the desired traceability. Furthermore, we are having a better overview of which requirements we have to verify and validate compared to our previous design matrix and risk matrix which was in Excel format. Lastly we are saving time during change control in general, this can be done within a few minutes while uploading a new version of a document, technical drawing etc. ### 3. Makes it Straightforward to Establish and Maintain an eQMS **Rating:** 5.0/5.0 stars **Reviewed by:** Amy H. | Small-Business (50 or fewer emp.) **Reviewed Date:** May 05, 2020 **What do you like best about Greenlight Guru Quality Management System?** I appreciate the intuitive interface that lets me keep track of documents, design control elements, and change all within a single platform. As a startup, we've used Greenlight Guru from day one of establishing our quality system, and being able to manage everything online has saved us from many headaches. The design control matrix in particular lets us note details about individual design control elements, link relevant documents, and manage risk, all within the same clean framework. The Greenlight Guru team is very responsive, and is constantly working to improve the regulatory compliance and user experience of the platform, and it shows. **What do you dislike about Greenlight Guru Quality Management System?** It does take some time to learn how the change control process works within the software, and it took us a little tweaking to figure out how to make the workflow work for us instead of creating more forms to fill. Some of the more recent updates have greatly improved the CO process, but especially at first it was somewhat redundant. Again, though, the Greenlight team has answered any and all questions we've had promptly, and we haven't had to work through this in a vacuum. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** We've been able to, as a small company, keep track of document management and approval very easily - I appreciate being able to see who has approved what document under what role with one click. Greenlight Guru is very conducive to remote work, with email notifications being sent out as tasks are created. And visually being able to see the design review status, risk elements, and document attachments for each design control element is very powerful for tracking and accountability. ### 4. GG **Rating:** 5.0/5.0 stars **Reviewed by:** cynthia a. | Quality coordinator, Small-Business (50 or fewer emp.) **Reviewed Date:** March 22, 2021 **What do you like best about Greenlight Guru Quality Management System?** It is easy to use and its features are useful **What do you dislike about Greenlight Guru Quality Management System?** Notifications could be more customizable **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Project management, change management, metrics ### 5. Great experience **Rating:** 3.5/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** March 26, 2021 **What do you like best about Greenlight Guru Quality Management System?** I like the UI and the fact that I can control and submit a design review in the system. **What do you dislike about Greenlight Guru Quality Management System?** I dislike that once routing starts, we can’t make edits to the documents. **Recommendations to others considering Greenlight Guru Quality Management System:** Contact support for any issues. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** We are solving the issue of housing all of our quality documentation in one system. ### 6. Solid QMS Platform for Med Device Startups! **Rating:** 4.5/5.0 stars **Reviewed by:** Ryan M. | Small-Business (50 or fewer emp.) **Reviewed Date:** September 16, 2020 **What do you like best about Greenlight Guru Quality Management System?** Beautiful interface, beautiful help guide, customer service availability, Design Traceability Matrix is much better with each update to link UN/DI/DOs, one stop shop for QMS compliance (pre and post market), amazing upload conversion from multiple formats to PDF, electronic approvals page automatically added to each document when published. **What do you dislike about Greenlight Guru Quality Management System?** Naming system (everything is DOC-###, no customization for prefixes), steep price point **Recommendations to others considering Greenlight Guru Quality Management System:** If you can afford it, I think it's a good system for startups. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** It allows everything needed for QMS compliance within a cloud-based system, with traceability and a great platform for novices to be able to go through the system with guidance. ### 7. GG is useful for RA,QA, but also designers and helps us to manage medical device and project. **Rating:** 4.5/5.0 stars **Reviewed by:** Anne C. | Small-Business (50 or fewer emp.) **Reviewed Date:** August 25, 2020 **What do you like best about Greenlight Guru Quality Management System?** To link risk control and design items and to manage current version documents and obsoleted documents effectively **What do you dislike about Greenlight Guru Quality Management System?** When I click 'published' in document management, all documents including change management are shown. But I would like to look only documents except change management stuff. **Recommendations to others considering Greenlight Guru Quality Management System:** If you struggle with communication between departments regarding documents and DHR, use Greenlight Guru software **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** All employees can find and look over current version documents easily via Greenlight Guru software. ### 8. Stunning document control with great customer support. **Rating:** 5.0/5.0 stars **Reviewed by:** Marcus C. | Small-Business (50 or fewer emp.) **Reviewed Date:** May 01, 2020 **What do you like best about Greenlight Guru Quality Management System?** For a startup the most amazing feature once understood how to use: start the document in GLG as a record - not routed in the morning, and end the day with the document in GLG published as record - not routed. This will ensure you have file version history, and never ever again have to leave a document locally on your PC. Then once ready for routing simply change the document to record - routed. This workflow is just stunning. **What do you dislike about Greenlight Guru Quality Management System?** We didn't know that the above "What do you like best?" was even possible. I would argue the top feature is essential. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Having a "golden truth" document control system with file logging version history. This is so important for development. ### 9. The Greenlight QMS software is excellent for managing medical device documentation! **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** May 06, 2020 **What do you like best about Greenlight Guru Quality Management System?** The software is easy to use, intuitive and workflows within it are updated in a timely manner to stay compliant with updated standards. It is very easy to train new employees on using the software as well. Greenlight.guru also has exceptional customer support, they go out of their way to help customers, respond to queries and are very receptive to feedback. **What do you dislike about Greenlight Guru Quality Management System?** We have had no issues with the software or the team, adopting the Greenlight QMS software has been a great experience. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** We are able to track documentation from all aspects of medical device development within Greenlight and that makes it very easy to manage, it is all in one place. The GO module is excellent for tracking design and development of projects, the traceability and risk matrix workflows provide excellent visibility on the project through all it's stages. Moreover the GROW module has been invaluable in managing CAPAs, audits in an organised fashion. The usability of the software is great and the way it is structured to facilitate ease of document retrieval as well as the built-in change control measures makes the process of going through an external audit very seamless as well. ### 10. Easy to use and a handy work of reference **Rating:** 4.5/5.0 stars **Reviewed by:** Jos W. | Small-Business (50 or fewer emp.) **Reviewed Date:** August 26, 2020 **What do you like best about Greenlight Guru Quality Management System?** Helps us comply to ISO13485. Very easy to find relevant procedures and records **What do you dislike about Greenlight Guru Quality Management System?** In-program document editing would be greatly appreciated **Recommendations to others considering Greenlight Guru Quality Management System:** Needs some time to set up correct implementation but once a good base is established its a very handy tool **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** One location for all documents. Programs brings structure in risk and design matrixes ### 11. Perfect for small businesses and startups **Rating:** 5.0/5.0 stars **Reviewed by:** Robbie J. | Chief Communications Officer, Small-Business (50 or fewer emp.) **Reviewed Date:** January 23, 2020 **What do you like best about Greenlight Guru Quality Management System?** The step-by-step process and built-in software validation make the entire process a million times easier than it would otherwise be, as well as alleviating the anxiety we felt in the past during FDA audits. We especially like the post-market software, and our customer service, QA manager, and warehouse teams have done a great job implementing it. **What do you dislike about Greenlight Guru Quality Management System?** While it is a great software tool, getting our engineers on board was difficult. It was introducing a new platform into their workflow that they weren't accustomed to using. A lot of their work is documented elsewhere, and so importing that into Greenlight, even though it can be done simply as reference documents, still felt like redundant work for them. **Recommendations to others considering Greenlight Guru Quality Management System:** Start early! **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** One of the biggest problems we had, which was pointed out in an audit, was our CAPA process. We had some big holes that Greenlight has since filled. **Official Response from Carly McCarthy:** > Hey Robbie - Our team appreciates you sharing your experience with Greenlight Guru. Glad to hear that you and your team have been able to fill in the gaps and are more confident about your processes since adopting Greenlight Guru. If there is anything else that we can do, please do not hesitate to reach out to our Customer Success team. Thanks! ### 12. User friendly software and all the technical support available from the team **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** November 09, 2020 **What do you like best about Greenlight Guru Quality Management System?** Greenlight Guru is constantly improving the software to meet user requirements along with the different regulatory needs. They take customer feedback and use it for continuous improvement of the system. **What do you dislike about Greenlight Guru Quality Management System?** Sometimes the validation package does is not released well in advance to allow the user to review the validation package prior to use. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Document control. Many benefits to having the Tag search function to find documents. ### 13. GG QMS to the rescue! **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Information Technology and Services | Small-Business (50 or fewer emp.) **Reviewed Date:** September 02, 2020 **What do you like best about Greenlight Guru Quality Management System?** GG QMS offers an ideal balance between documenting detailed project information and representing that information in a clear, intuitive graphical format. **What do you dislike about Greenlight Guru Quality Management System?** Not a "dislike," but the traceability of risk information--individual Hazard=>Foreseeable Event=>Hazardous Situation=>Harm pathways is challenging at times. Different "pathways" to the same Harm must be represented by different versions of the Harm, even if it's the same fundamental Harm. GG's solution is good, just could be more flexible to account for complex risk analyses. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Documentation of Design Controls (User Needs and Design Inputs) and Risk Analysis information. Effective and efficient process for entering a revising that information ### 14. Top Notch Design Controls & Risk Management Platform! **Rating:** 5.0/5.0 stars **Reviewed by:** Christie J. | Quality , Small-Business (50 or fewer emp.) **Reviewed Date:** December 04, 2019 **What do you like best about Greenlight Guru Quality Management System?** The design controls and risk management matrices offer a seamless way to ensure all requirements and risks have been identified, verified, and/or mitigated. I love not maintaining multiple excel and word documents to create and update my design history file! The document control portion is also seamless and is easy to upload and search for documents. **What do you dislike about Greenlight Guru Quality Management System?** The complaint management system would be improved by offering fields to complete that are all viewable on one screen, with direct and relevant questions to answer. It is hard to consistently input complaints in the same way because the fields are not always intuitive and are on multiple screens. **Recommendations to others considering Greenlight Guru Quality Management System:** Use this software to begin design controls and risk management activities from the beginning!! It allows us to save so much time by having online design reviews. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** I can now update requirements and risks quickly and ask others to review changes instantaneously. The document control lets us work remotely and not shuffle paper back and forth!! **Official Response from Carly McCarthy:** > Hi Christie - Thanks for taking the time to share your positive remarks about Greenlight Guru. We are delighted to hear that your team's experience with our MDQMS software has streamlined your product development processes and given you time back in your day for value-add activities. As we continue to evolve our software, please feel free to reach out to our Customer Success team with your feedback. ### 15. Product Development Streamlined **Rating:** 4.5/5.0 stars **Reviewed by:** Michael E. | Senior ME, Product Manager III, Small-Business (50 or fewer emp.) **Reviewed Date:** November 27, 2019 **What do you like best about Greenlight Guru Quality Management System?** All of the advantages of an electronic QMS plus a more streamlined and logical way of thinking through risk management and the linking back to Design Controls. really allows the product development team to focus on what's really important and that's providing innovation and quality products that meet the regulations and the users needs making the most impact on the patients. **What do you dislike about Greenlight Guru Quality Management System?** Very minimal to dislike here. Their customer success team has been true to their title and making sure that we are doing the best practices in the software and if we have any dislikes they are heard and responded to in a timely manner. In our company we have multiple devices that share common requirements and it can be difficult to visually see what design controls are already tied to specific devices. **Recommendations to others considering Greenlight Guru Quality Management System:** Perform a sandbox demonstration with an actual project and test the system it will teach you deficiencies in your system and what Greenlight truly has to offer **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** A paper based QMS that has to constantly change and conform to new standards (internally and externally), which significantly impacts every product line and makes it difficult to keep up to date, manage, and have an audit ready DHF that is easily understood by an independent software. As part of the product development team, we are focused on making process's efficient and value added so the engineers can focus on innovation and quality products as opposed to tedious documentation to manage. So far we have been converting an existing DHF (11 years old) to the Greenlight system and we have completed roughly 80% of that transition in 3 months with a small team. So far I have been very pleased and am excited to roll this out globally ### 16. Excellent software for a small engineering team **Rating:** 4.0/5.0 stars **Reviewed by:** Andrew E. | Product Engineer, Medical Devices, Mid-Market (51-1000 emp.) **Reviewed Date:** November 26, 2019 **What do you like best about Greenlight Guru Quality Management System?** Greenlight has excellent traceability built in to your design controls. No wasting time in Excel adding & deleting lines then having to update links... Everything is automatically traceable after only a few clicks. There are frequent updates, including many quality-of-life updates, that make the software better and easier to use. **What do you dislike about Greenlight Guru Quality Management System?** Organizing project documents can be a little cumbersome if you're trying to retrofit Greenlight into an existing QMS. It can also take some time to onboard users who are used to a different system, however Greenlight's help center is excellent. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** As a small engineering team, we've been able to utilize our time better by being able to quickly iterate through many rounds of design. It has sped up our approval process from our previous paper-based system and made our records much more organized. We passed an MDSAP audit with ease as every question the auditor had was only a few clicks away! **Official Response from Carly McCarthy:** > Hi Andrew - Our team appreciates your review and feedback about Greenlight Guru. Refocusing your team's time to more value-add activities, including design controls, is a benefit many of our customers experience when switching to Greenlight Guru. Please do not hesitate to reach out and let us know if there is something we can do to further enhance your experience with Greenlight Guru. We are glad to see you are reaping the benefits of an MDQMS. Congrats on passing your MDSAP audit with ease! ### 17. Excellent QMS option for startups and mature organizations alike **Rating:** 5.0/5.0 stars **Reviewed by:** Devon C. | Chairman, Technology Advisory Board, Medical Devices, Small-Business (50 or fewer emp.) **Reviewed Date:** November 26, 2019 **What do you like best about Greenlight Guru Quality Management System?** As an executive advisor to focused primarily on supporting early-stage medical device companies, I appreciate Greenlight Guru's designed in flexibility to implement relevant modules in stages rather than forcing a young company to adopt a full QMS all at once. The suite of tools offered in GO vs. GROW is appropriate and even within either a company doesn't necessarily need to use the full suite right away. For example, the Document Management Capabilities and Change Control (late 2019) of GO are an outstanding starting point. As a 20+ year professional in the medical device development and commercialization space, I sincerely appreciate how Greenlight Guru's QMS solutions are created by experienced Med Device professional exclusively for the Med Device community. Before launching my own advisory firm, my prior history includes deep experience working within at least two world-class, triple-digit Billion USD market cap medical device and pharma companies and has provided me with an opportunity to see *many* different QMS software solutions. Without a doubt, Greenlight Guru holds its own against those options and is an outstanding options even for companies that large. **What do you dislike about Greenlight Guru Quality Management System?** I believe many companies underestimate the effort and costs involved with validation of internal software tools. It can be overwhelming for the unprepared. I love how Greenlight Guru each improvement is constantly improving and with each release, a full validation package is produced and made available. This is an enormous benefit but in order for Greenlight Guru to do this, they have to reduce the amount of customization available to users. I have found a handful of workflow differences or customization options I would have dislike not having those options occasionally. The good news is that Greenlight Guru has, in my opinion, been very open to listening to my feedback and ideas for improvement. The customer support is outstanding and I feel my opinion is valued when I interact with their team. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Greenlight Guru has impacted my work positively by allowing me to work with early stage teams in a step-by-step QMS deployment (something I call "Just-In-Time Quality") that allows me to establish an appreciation for quality that lays the foundational quality culture before I introduce more complicated aspects of a ISO 13485 compliant QMS. ### 18. Greenlight Guru representatives are always there to help. **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** May 04, 2020 **What do you like best about Greenlight Guru Quality Management System?** The interface is user-friendly and if any issues do arise, the Greenlight Guru representatives are readily accessible and very helpful. Uploaded documents are sorted by condition into drafts, awaiting review, routing, or published, which is useful to track document status and keep on schedule. Change order routing allows you to create groups with team members to review and approve documents efficiently. Design matrices are easy to create and modify as needed by linking and un-linking design inputs and user needs for example. **What do you dislike about Greenlight Guru Quality Management System?** Since an update, users can no longer publish individual documents associated with the same change order at different times. This may force more work to be done in writing extra change orders. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Greenlight Guru provides a collaborative space for colleagues to access and revise documents as product development occurs. Document review can be done in parallel which can expedite the approval process if needed. ### 19. QMS for medical product development consultancy **Rating:** 4.5/5.0 stars **Reviewed by:** Reade H. | Sr. Medical Device Specialist, Mid-Market (51-1000 emp.) **Reviewed Date:** November 25, 2019 **What do you like best about Greenlight Guru Quality Management System?** We are a development consultancy that works with large and small medical device companies to develop their products. We needed to implement our QMS to assure our clients we understand, and are able to operate as required in the regulated medical space. Greenlight was by far the most comprehensive tool we reviewed, the easiest to use for “non power” users, and eliminated the mess of paper systemsent consultancy that **What do you dislike about Greenlight Guru Quality Management System?** We are not developing our own devices, so the cost to maintain an active QMS in a consultancy is high. However, because Greenlight is easy to use, we do not require any full-time staff to maintain the system. We view this as a good tradeoff, as having an active QMS is becoming table stakes for development partners. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Greenlight solved the problems of 1) requiring full time staff to run a QMS, 2) Archaic use of paper systems, 3) Staff acceptance of, and willingness to use a QMS system. Biggest benefit realized is the fact that many of our medical device customers require their partners to be ISO certified, and this has become a strategic advantage for us. ### 20. One stop shop for Medical Device QMS software **Rating:** 5.0/5.0 stars **Reviewed by:** Maria M. | Quality Manager, Small-Business (50 or fewer emp.) **Reviewed Date:** May 22, 2018 **What do you like best about Greenlight Guru Quality Management System?** I love that everything is 'under one roof', the design, document control, training, change management, NC,s CAPAs, Feedback and Audits. I really love the risk within design, it is set out clearly, easy to use and clear to see the risks at a glance. I also love that Greenlight have a continual improvement approach and new features being added to enhance the usability and performance from time to time. Also, their customer service is top class. I really don't know how I would do my job without it! **What do you dislike about Greenlight Guru Quality Management System?** There are not too many areas, which I dislike, however If I was pushed, I would say the search function. Although this has greatly improved recently. I feel new companies need to seriously consider the file naming structures for ease of retrieval. Since the improvements and updates, we have find it easier to find what we need and we've amended our file naming structure,(removing the _) however, so we still have some historic documents that are difficult to locate at times. **Recommendations to others considering Greenlight Guru Quality Management System:** Carefully consider the file naming structure, clearly define the roles and responsibilities and complete user specific training, as not all users have the same permissions or issues. Really the only advice I can give, is don't wait any longer, implement Greenlight guru today, to help maintain a first class quality management system, with world class customer support. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Communication problems and task management issues are easier to manage with Greenlight. Also the management of NCs, CAPAs, Audits and customer feedback. The templates are so simple, yet very effective at demonstrating the steps taken to investigate the issue, establishing the root cause, and further actions needed. Also allowing the approval to be routed as a formal review. The management of risk throughout the process (design, doc management, GROW etc), is also handled really well, which is a bonus! There is so much flexibility within the entire Greenlight system and depending on the product, we can use the features to suit our process flow and this is invaluable. **Official Response from Carly McCarthy:** > Hi Maria, Thank you for your positive remarks about Greenlight Guru. Our team strives to maintain collaborative relationships with our customers in order to continuously improve our software and help our customers succeed. Again, we appreciate you taking the time to share your experience with Greenlight Guru! ### 21. Robust, Intuitive and user-friendly. **Rating:** 5.0/5.0 stars **Reviewed by:** Jacob L. | Product and Process Development Scientist, Pharmaceuticals, Small-Business (50 or fewer emp.) **Reviewed Date:** November 24, 2019 **What do you like best about Greenlight Guru Quality Management System?** Design control! Having had to create design history files using word and excel templates - in particular an excel template for the input-output traceability matrix, it's always stuck in my mind how much time goes into creating and maintaining that traceability. With GG, of course there is the time upfront to build it, but that is streamlined and easy by comparison, and maintaining that traceability is almost a non-issue. What definitely adds a lot to how much I like Greenlight Guru is their team, all of whom have been eager to help and share their knowledge and experience about the industry. **What do you dislike about Greenlight Guru Quality Management System?** Within design control, common elements between products or product families need to be recreated, for example, meaning that a design output for single part specification might have a number of unique entries across your range of products. Referencing other design control elements slims that down (e.g. in one DHF have a fully completed set of information, and in another DHF reference the first. Purely in terms of the number of mouse-clicks / keystrokes / time spent referencing between families it would be good to have a more integrated/automated solution, such as a field to reference the project & unique ID of a design control element which fully populates the design control element your working on. Seeing the improvements the Greenlight Guru team have made to their already awesome EQMS platform in the short time I've used it, I am confident that there will be something on the horizon soon to address this. **Recommendations to others considering Greenlight Guru Quality Management System:** I think you can rely on the Greenlight Guru team to have your best interests at heart, they talk about their mission being to help improve the quality of life by improving the quality of the medical device industry (not an exact quote) and they walk the walk. It's never too early or too late to start a conversation with them - so far I as can tell, the earlier the better. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Our primary problem as an organisation was maintaining document control, and Greenlight Guru has pretty much fixed our issues entirely just by implementing it. My work involves DHF's, and the combination of the expertise within the Greenlight Guru team and the Design Control aspects of Greenlight Guru platform I am confident that we can have a DHF that adds value to the organisation. **Official Response from Carly McCarthy:** > Hi Jacob - Thanks for taking the time to write your review. We greatly appreciate your positive remarks and feedback about Greenlight Guru. We are glad to hear that Greenlight Guru has helped your team maintain document control and traceability, as well as preparing a DHF that adds value to your company. Our team enjoys hearing the success of our customers and positive feedback about our team. We also appreciate you voicing your feedback regarding design controls and have already forwarded that on to our Customer Success and Product teams. Thanks again! ### 22. Worth Every Penny **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** April 30, 2020 **What do you like best about Greenlight Guru Quality Management System?** GG software has become an everyday tool used by our company. I cannot calculate the amount of time or money it will save in our FDA submissions and our ISO audits. The staff is extremely helpful and generous about answering questions. The response time is fast and answers are clear cut. **What do you dislike about Greenlight Guru Quality Management System?** I cannot think of any downsides to using this software. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** As a new company with less than 20 employees we do not have the manpower to develop a QMS from the ground-up. The team at GG has done that for us. Just the time and effort it has saved is immense. Additionally, this is not like a consultant coming in, making a template and leaving. GG provides a flexible workspace for us to create the QMS as needed for our niche application while adhering to the ISO and FDA standards. **Official Response from Carly McCarthy:** > Thanks for sharing your experience with the Greenlight Guru team and the benefits you have seen since adopting our software! We are always pleased to hear more about how we are saving teams time and money while eliminating the manual labor of establishing a quality system. Thanks again for sharing! ### 23. Greenlight Guru got us on track **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** January 17, 2020 **What do you like best about Greenlight Guru Quality Management System?** GG has helped streamline the growth of our QMS. With the simple uploading,tracking, and approval process we have been abel to focus ont he content rather then the logistics of creating new records and procedures. **What do you dislike about Greenlight Guru Quality Management System?** Lacks web based training module which would really help us track who has been training. This is more important during the roll out phase when more documents are added constantly so it is easy for someone to fall behind. **Recommendations to others considering Greenlight Guru Quality Management System:** I would recommend to have a potentially usable paper QMS first. This will give a greater appreciation to the all web based approach of GG. Additionally it will give better insight on how to tweak procedures to reduce the overly burdensome work of a paper system. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** We are solving the difficulty of maintaining a rapidly growing QMS. At a small business, it fell on one person to both build and run the QMS. GG helped reduce the workload on the maintenance perspective allowing us to focus on the development. ### 24. Bad experience, not reliable **Rating:** 0.0/5.0 stars **Reviewed by:** Myriam D. | Directeur, Small-Business (50 or fewer emp.) **Reviewed Date:** June 12, 2020 **What do you like best about Greenlight Guru Quality Management System?** User friendly: quite easy to learn (only for document approval process). Technical support for minor issues **What do you dislike about Greenlight Guru Quality Management System?** No appropriate access control to the different modules. Not intuitive. No possibility of document review in parallel. No possibility to structure the documents and no link between documents. Value for the money: very expensive. Bugs such automatic approval of documents when login in. Technical support for major issues **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** QMS document approvals on a faster way **Official Response from Carly McCarthy:** > Hi Myriam, We're so sorry to hear that this was your experience with Greenlight Guru. There are several platform features we pride ourselves on, all with functionality that we think that your team can benefit from, including: - Advanced user control and permissions throughout the platform - Flexible document review & approval workflows, with Part 11 compliant e-signatures and revision control - Link Anything: a feature set that allows you to create links between all different objects in your quality system, alongside the use of tags to further organize and structure your documentation - Customer support coupled with timely technical support for issues - large or small - including any one-off bugs you may have experienced If you'd like to dive deeper to help us understand the disconnect, we'd really appreciate your feedback. We have also launched several new features, with more on the way that we would love to share with you. Please reach out to me (carly.mccarthy@greenlight.guru) directly so we can help you better learn the full-feature set, added benefits, and long-term value Greenlight Guru has to offer. ### 25. A good tool for organizing your QMS work **Rating:** 4.0/5.0 stars **Reviewed by:** Shoshana F. | CEO, Small-Business (50 or fewer emp.) **Reviewed Date:** August 11, 2020 **What do you like best about Greenlight Guru Quality Management System?** It is a simple and quite intuitive tool. **What do you dislike about Greenlight Guru Quality Management System?** Too many notifications some of which are not necessary. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Change control, design control and document control are easily achieved. ### 26. Game changing eQMS **Rating:** 5.0/5.0 stars **Reviewed by:** Dom M. | President & CEO, Medical Devices, Small-Business (50 or fewer emp.) **Reviewed Date:** November 22, 2019 **What do you like best about Greenlight Guru Quality Management System?** The implementation and use of greenlight.guru for our quality management system allowed our young start up company to stay nimble, maintain a minimal headcount and stay focused on the correct quality and design control items that really matter! In my 25 years of medical device experience with some of the largest med device companies, I have never been able to use such an effective QMS system! **What do you dislike about Greenlight Guru Quality Management System?** The change control process is not as streamlined as it could be. I do know this may be addressed during the next major release. **Recommendations to others considering Greenlight Guru Quality Management System:** If you are a start up, I suggest starting the implementation early as it will allow you to save time early on but then definitely in the later stages of a project. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** One of the biggest benefits for using GG for our small start up is the savings in head count. I honestly think with using GG, we were able to avoid hiring two full time QA/RA staff members. GG allows us to have a strong QMS system in place and helps us developing our product rapidly with the right quality focus that makes for the best product possible. **Official Response from Carly McCarthy:** > Hi Dom - We appreciate you taking the time to share your remarks about Greenlight Guru. We are pleased to hear that our MDQMS has helped your business on several fronts, from headcount to streamlined quality. Our latest release included new capabilities around Change Management that we hope you are finding value in. If you have any additional needs or feedback, please do not hesitate to reach out to our Customer Success team - Thanks! ### 27. Excellent QMS system. Constantly updating and improving **Rating:** 4.5/5.0 stars **Reviewed by:** Spencer C. | Small-Business (50 or fewer emp.) **Reviewed Date:** May 04, 2020 **What do you like best about Greenlight Guru Quality Management System?** Design and Development module, RIsk Management module, CAPAs, Change Management module, and great support team **What do you dislike about Greenlight Guru Quality Management System?** Steep learning curve and lots of manual entry when first switching **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Change management helps us to keep on track with what change orders need to be released. Design and development and risk management help us keep our R&D better organized. ### 28. Ideal QMS software for Medcial Device companies **Rating:** 5.0/5.0 stars **Reviewed by:** Robert U. | President, Small-Business (50 or fewer emp.) **Reviewed Date:** November 26, 2019 **What do you like best about Greenlight Guru Quality Management System?** The software allows you to be paperless when you want to be, but with hard copies when you need them. Routing documents for various changes and sign-offs is easy and fast, too! Plus their support team is great and they are quick to make changes and additions based on customer feedback. **What do you dislike about Greenlight Guru Quality Management System?** Haven't found anything to 'dislike' and we've been using the software for 3-years **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Restructuring our old "paper-driven" quality management system to be fully compliant with ISO 13485:2016 seemed like a daunting task. The Greenlight Guru software and support team were very helpful and we discovered that many of our current practices and procedures could be adapted to fit into their QMS software without having to change everything we were already doing. **Official Response from Carly McCarthy:** > Hey Robert - Thanks for sharing your experience with Greenlight Guru. Please continue to share your successes and feedback with our Customer Success team as we continue to evolve our software. Glad to have you as a customer! ### 29. Greenlight Highly Recommended! **Rating:** 5.0/5.0 stars **Reviewed by:** Itamar L. | Small-Business (50 or fewer emp.) **Reviewed Date:** May 04, 2020 **What do you like best about Greenlight Guru Quality Management System?** Very good user interface and the best software I have used for Design and Development and Risk Management. **What do you dislike about Greenlight Guru Quality Management System?** I would like a little more flexibility on numbering scheme for documents. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** I can use Greenlight Guru as a QMS software and a repository ### 30. Great tool, better team **Rating:** 5.0/5.0 stars **Reviewed by:** Ryan E. | Director Regulatory Affairs and Quality Assurance, Small-Business (50 or fewer emp.) **Reviewed Date:** July 01, 2019 **What do you like best about Greenlight Guru Quality Management System?** Greenlight Guru enabled us to focus on our products and customers earlier, because we didn't have to build our QMS from scratch. The software works well and saves us significant time from a paper-based system. The product and team behind it have been great from first discussions, through implementation, and now actively managing our Quality System. **What do you dislike about Greenlight Guru Quality Management System?** Nothing, any feedback we've given has been acted on and a few minutes on the phone with a team member can usually solve any issues we've encountered. **Recommendations to others considering Greenlight Guru Quality Management System:** I would strongly recommend Greenlight Guru Quality Management Software. The software continues to improve, and the team that supports it is top notch. In the months since implementing Greenlight Guru, our executive team has mentioned several times that the software was a great choice and the team continues to deliver valuable support. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** As a startup, we needed to move quickly to get our product to market, and Greenlight Guru allows us to do that efficiently and in compliance. We have employees in several locations and through Greenlight Guru, everyone has access to procedures and records that they need to be successful. Greenlight Guru has also shortened our timeline for ISO 13485 certification because we did not need to build an eQMS. **Official Response from Carly McCarthy:** > Hello Ryan - Thanks sharing your positive feedback about our software and the team behind it. We are excited to hear that our software has positively impacted your collaboration efforts, as well as your timeline for gaining ISO 13485 certification. Our team loves to hear our customer's stories, successes, and feedback about using the software and working with our team. If there is anything we can do to make your experience any more enjoyable, do not hesitate to reach out and provide us with your feedback. Thanks again! ### 31. Currently Using GLG for Document control **Rating:** 5.0/5.0 stars **Reviewed by:** Ken S. | Quality Manager, Small-Business (50 or fewer emp.) **Reviewed Date:** November 25, 2019 **What do you like best about Greenlight Guru Quality Management System?** One place for all of our documents. Tons of amazing resources from ebooks to blogs to white papers to webinars. They always seem to be there for a call, email or anything else you might need **What do you dislike about Greenlight Guru Quality Management System?** All my dislikes stem from our company :) **Recommendations to others considering Greenlight Guru Quality Management System:** It was the best option after reviewing 5 other competitors and we still feel that way a year later. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Minimizing confusion as to what the latest version of any document is ### 32. My experience with GLG has been overall very good. **Rating:** 4.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** November 25, 2019 **What do you like best about Greenlight Guru Quality Management System?** The most helpful aspects of GLG in my opinion are twofold: 1) How complete tractability is maintained rather effortlessly and 2) the superb documentation maintenance and routing workflow. **What do you dislike about Greenlight Guru Quality Management System?** I dislike how inflexible the current risk estimation options. I'd like to be able to use L1 and L2 probabilities for risk estimation instead of just 1 cumulative number. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** The eQMS is amazing compared to the paper based system we had before purchasing GLG. Similarly, the visibility and access to documentation for all team members is a big plus. Again, tractability is very easy to maintain and is a big help compared to trying to do this in a paper based system. **Official Response from Carly McCarthy:** > Thanks for sharing your experience with Greenlight Guru and the benefits you have seen since adopting our software. Please don't hesitate to share your feedback with our Customer Success team as we continue to evolve our software. ### 33. User-friendly software **Rating:** 4.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Mid-Market (51-1000 emp.) **Reviewed Date:** November 22, 2019 **What do you like best about Greenlight Guru Quality Management System?** I like that the software is so easy to use with minimal training. The process workflows are simple to understand and are as per Design Controls, thereby reducing the need for customisation. **What do you dislike about Greenlight Guru Quality Management System?** I would prefer if the Validation package of the software were a bit more detailed as most medical device company QMS' have very strict rules for Validation of software. For example, it would be helpful to have Validation of user roles of GG. Also, would have liked to be able to link Traceability Matrix entries across project Components. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** It has made the management of design controls a lot easier to maintain and update, unlike using the commonly available Microsoft tools. I like how easy it is to link the Traceability Matrix to the Risk Control Matrix for a project. ### 34. Great tool for MedDev starters and movers from paper based systems. **Rating:** 4.5/5.0 stars **Reviewed by:** Konstantin A. | QA/RA Manager, Mid-Market (51-1000 emp.) **Reviewed Date:** April 25, 2019 **What do you like best about Greenlight Guru Quality Management System?** The setup of the system is very much "plug and play". No need for cumbersome implementation or configuration. Very good for companies that come from paper (or Excel) based Design Controls and Risk Management documentation and do not need to migrate from another system. **What do you dislike about Greenlight Guru Quality Management System?** Difficult to say, since the people at Greenlight guru are very actively expanding and improving the system, both regarding user-friendliness and functionality. At this time I would say: the system is specifically designed to fulfill compliance requirements and automatically built a DHF from the information you put in. It is therefore not (yet) suited to document and manage the entire development process. As a user, you have to be aware what is not relevant to be included in the DHF. You may want or need to manage other information, for instance feasibility and concept design documentation outside Greenlight guru. **Recommendations to others considering Greenlight Guru Quality Management System:** Clearly define your current and future needs. Talk about it with the Greenlight guru team to decide if it is a good solution for you. Don't look only into the publicly available information. There's a lot of development going on behind the screens and what you need and don't see yet, might already be in development. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** We use only the GO platform, foremost to achieve fully traceable Design Controls and Risk Management documentation in product development. Secondary as a Document Management system for general QMS related documents, even if they are not linked to a specific product development project. ### 35. Greenlight Guru made our transition from a startup to a FDA-cleared medical device company simple. **Rating:** 5.0/5.0 stars **Reviewed by:** Stephen P. | Senior Quality Engineer, Small-Business (50 or fewer emp.) **Reviewed Date:** July 02, 2019 **What do you like best about Greenlight Guru Quality Management System?** Greenlight Guru covers a great deal of ground, when it comes to quality. Their software seamlessly connects the various outputs of the Risk Management process into the Design Control process to provide the most complete picture of Product development that I have ever seen. Add in the ability to link to any documents, tasks, or integrated software project management, along with post market / continuous quality improvement features like audits, non-conformance management, CAPA and complaint handling... you have a single portal to all of your quality work product. Not only is their quality management software growing, evolving, and improving, but Greenlight Guru provides a comprehensive system of template documents, expert knowledge, understanding and wisdom through their expansive web content, and most importantly, tailored support with their dedicated success team members. This is all to assist you in building the best quality system that fits your needs. **What do you dislike about Greenlight Guru Quality Management System?** I am looking forward to expansions of their software in the areas of Training Management, Supplier Management, and further Integrations with Design/Project Management. **Recommendations to others considering Greenlight Guru Quality Management System:** They are continuously improving the software, so be certain to provide comments and suggestions. Acceptance and utilization of any software is based upon how well the feedback is implemented, but that two-way street begins with the user. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Starting from scratch and building up to a fully-compliant, comprehensive quality system has been the overarching difficulty, and I don't think it would have been easy to do without Greenlight Guru. Not only have I been able to better understand how our quality system works, but I am able to convey the full picture of our device design to auditors, effortlessly. **Official Response from Carly McCarthy:** > Hey Stephen - Our team really appreciates the positive feedback! It is great to hear how useful our software is to our customers, as well as our template packages and expert knowledge base, in gaining a full view of their quality system over the lifecycle of their device. We also agree with you - sharing feedback is vital as we continuously shape our software to best fit the needs of the medical device industry. Thanks for being a customer! ### 36. GG is great for risk management and concurrently plan design controls **Rating:** 4.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** May 01, 2020 **What do you like best about Greenlight Guru Quality Management System?** Design control matrix integration with risk management **What do you dislike about Greenlight Guru Quality Management System?** There aren't more automated links or references **Recommendations to others considering Greenlight Guru Quality Management System:** For early stage medical device company it is all you need. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Risk Management + D&D Planning is one unit moving together. **Official Response from Carly McCarthy:** > Thanks for taking the time to review Greenlight Guru! We are glad our software is providing the structure to unify your risk management and D&D efforts. As for wanting more automated links and references - we hear you. We have some new features on the way that will assist you with this. Please reach out to your Customer Success Manager to learn more! I encourage you to reach out to your GG Customer Success Manager to learn more about our upcoming feature releases - you won't regret it! ### 37. Clean, user-friendly, great support **Rating:** 3.5/5.0 stars **Reviewed by:** Verified User in Medical Devices | Mid-Market (51-1000 emp.) **Reviewed Date:** November 25, 2019 **What do you like best about Greenlight Guru Quality Management System?** The bi-weekly support sessions from our expert, Jesseca, have been invaluable to our adoption of the Greenlight Guru software. Her help, as well as the extensive online help database, have eased our transition. **What do you dislike about Greenlight Guru Quality Management System?** It is difficult to stay oriented within the design controls page, especially when you are dealing with multiple layers of sub components. It would help if there was a better way to visualize links. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Transition away from a paper-based system where we would often struggle to find documents, stay organized, and prepare for audits. **Official Response from Carly McCarthy:** > Thank you for taking the time to share your remarks about Greenlight Guru. We are glad to hear that our team has made an impact on your organization as you transition from a paper-based system and that you have found value in more than just our software. I have relayed your feedback and recommendations to our Customer Success and Product teams. We appreciate your feedback! ### 38. We can focus on the work - not the administration! **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Mid-Market (51-1000 emp.) **Reviewed Date:** May 30, 2019 **What do you like best about Greenlight Guru Quality Management System?** The users are excited to use it (It's fun to use). It keeps the work moving - no more hunting for signatures or documents gathering dust in In-trays. It also helps with accountability - it's clearly visible if document reviews or design reviews are being delayed. The work is also more secure and accessible for anywhere. T **What do you dislike about Greenlight Guru Quality Management System?** We can't think of anything at this time! **Recommendations to others considering Greenlight Guru Quality Management System:** Take your time and be open minded! **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** It's helped us to simplify our change management and to rethink the way in which we've been documenting risk related to the product. Relating the risk to the design is as it should be. In the past the design and risk management were two separate files that were hard to update together. **Official Response from Carly McCarthy:** > We appreciate you taking the time to share your positive feedback about Greenlight Guru! Our team is pleased to hear that our software is benefiting your team in more ways than one. Keeping your team moving and enhancing or simplifying your processes around design controls and risk management are just a few of the beneficial changes that we see with many of our customers. Thanks again. Glad to have you as a customer! ### 39. Experienced executive in the medical device startup space **Rating:** 5.0/5.0 stars **Reviewed by:** Ward B. | COO, Small-Business (50 or fewer emp.) **Reviewed Date:** March 11, 2019 **What do you like best about Greenlight Guru Quality Management System?** Ability to capture all critical documents, design reviews and risk analysis electronically. The need to keep up with loose paperwork and signatures is eliminated. Documents are automatically routed through the system. The needed approvals cannot be bypassed. The design requirements and risk analysis are well organized. **What do you dislike about Greenlight Guru Quality Management System?** Navigation can sometimes be a bit cumbersome, but it is a necessary evil for compliance. **Recommendations to others considering Greenlight Guru Quality Management System:** The software is very intuitive and eliminates the problems with a paper quality system. Everything is organized in a way which insures your quality system will be compliant. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Proper and effective maintenance of the quality system. **Official Response from Carly McCarthy:** > Hello Ward, Thank you for your positive feedback! Glad to hear that you are enjoying our eQMS software and appreciate its benefits over a paper-based system. Our workflows are designed to keep teams organized and working efficiently by capturing what is required to be compliant with industry-specific standards. We would love to hear any feedback you may have about the system navigation as we are continuously evolving our software's interface and functionalities. Please do not hesitate to reach out to our team. Thanks! ### 40. Great products even better service. Easy to implement. **Rating:** 5.0/5.0 stars **Reviewed by:** Amy P. | VP Operations, Small-Business (50 or fewer emp.) **Reviewed Date:** February 07, 2019 **What do you like best about Greenlight Guru Quality Management System?** We are a start up organization. We partnered with Greenlight Guru based on the quality and completeness of their products. We were blown away by the quality of their service, partnership and professionalism. In less than 2 months we were able to implement a very robust quality system. They were with us every step of the way - providing great support, advice and follow through. Greenlight has a fantastic team. Well done! **What do you dislike about Greenlight Guru Quality Management System?** All was great. The only area was cost. But the spend has been worth it so far. **Recommendations to others considering Greenlight Guru Quality Management System:** If you are a start up organization, you cannot go wrong with Greenlight Guru. It does cost money, but the money is well spent. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Quick implementation of a quality management system for a start up organization. **Official Response from Carly McCarthy:** > Hey Amy, We really appreciate you taking the time to share such positive feedback about our QMS software and our team here at Greenlight Guru! We are also glad to hear that the implementation process was quick and seamless for your company. At Greenlight Guru we see ourselves as a trusted partner to our customers, ready to help throughout all steps of the journey. If there is anything else that we can do, please do not hesitate to reach out to our Customer Success team. Thanks again! ### 41. Nice system that's easy to implement. **Rating:** 4.0/5.0 stars **Reviewed by:** Brian M. | Quality Assurance, Medical Devices, Small-Business (50 or fewer emp.) **Reviewed Date:** February 04, 2019 **What do you like best about Greenlight Guru Quality Management System?** I like how simple it was to implement. The team at Greenlight are also very interested in ways to improve the system and the user's overall experience. **What do you dislike about Greenlight Guru Quality Management System?** There are still some workflows that aren't as intuitive as I would like. There's nothing I've seen that let's you quickly see if there are outstanding open items prior to closing a nonconformance. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** We are mostly using the Document Control system. It's been a big improvement over our old paper system. **Official Response from Carly McCarthy:** > Hi Brian, Thank you for your positive feedback! We appreciate your kind words regarding our interest to improve our platform by listening to our customers. That being said, we have taken your feedback and will be sharing it with our team to further improve our system. Please reach out to our Customer Success team if you have any additional feedback that would benefit the overall experience of using Greenlight Guru. Thanks again! ### 42. MHP's experience with Greenlight Guru. **Rating:** 4.0/5.0 stars **Reviewed by:** Savanah S. | QA/RA Manager, Small-Business (50 or fewer emp.) **Reviewed Date:** May 19, 2019 **What do you like best about Greenlight Guru Quality Management System?** Greenlight Guru has a great, young and energetic customer service team. The system is built for ISO 13485:2016 compliance that makes implementation easy. The training resources are awesome. **What do you dislike about Greenlight Guru Quality Management System?** The way training is documented is a little time consuming to create additional documentation. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Easy access to data is one problem and always being audit ready. **Official Response from Carly McCarthy:** > Hi Savanah - Thanks for taking the time to share your feedback about Greenlight Guru and our Customer Success Team. It is great to hear that our software has enhanced your audit readiness by providing clear, easy access to your quality information. We also hear your feedback regarding training documentation and are actively working to address your concerns. We appreciate your kind words and hope that you continue to share your feedback with us as we are continuously improving our software. Thanks! ### 43. Medical Device QMS system compliant and ready to use out of the box **Rating:** 4.5/5.0 stars **Reviewed by:** Niels F. | Small-Business (50 or fewer emp.) **Reviewed Date:** July 18, 2018 **What do you like best about Greenlight Guru Quality Management System?** Greenlight Guru is fully focused on medical device manufacturers. As a result, it provides ISO 13485 and FDA QSR compliant methods out of the box with no setup. It is also deployed and maintained by GG reducing any associated hassle. In addition, they provide validation protocols and reports which eliminates that obstacle as well. Overall there is almost no overhead in using this system (installation, backup, updates, validation are all covered by GG) while it does remove a lot of the overhead of a paper system. It is straightforward in use and functionality is continuously added to cover more and more of the QMS. The Greenlight Guru team is well experienced in Medical Device Quality Management and very fast in responding to questions. **What do you dislike about Greenlight Guru Quality Management System?** Because it is ready to use out of the box, there is also less configuration possible which means processes typically need to be adapted to the functionality of GG. It is a disadvantage compared to more expensive complex systems that require days of configuration before they can be used. It is however a small price for a maintenance free eQMS. **Recommendations to others considering Greenlight Guru Quality Management System:** If you don't want to loose time in setting up an eQMS, configuring it to suit your needs and Medical Device regulation/standards, maintenance, fixes and upgrades, then look no further **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** I recommend Greenlight Guru to clients when I see they can benefit from: - A paperless QMS accessible from anywhere - An easy to use ISO and FDA+part11 compliant system which also helps streamline internal processes It has made development projects easier to document and manage. This was also visible during audits were auditors had little trouble seeing the process and projects were in compliance. I also see GG as a learning tool for employees because it reduces errors and guides the user. ### 44. GG review: easy and complete **Rating:** 4.5/5.0 stars **Reviewed by:** Schelte P. | Quality Manager, Mid-Market (51-1000 emp.) **Reviewed Date:** February 04, 2019 **What do you like best about Greenlight Guru Quality Management System?** - Complete traceable design control - Easy to learn **What do you dislike about Greenlight Guru Quality Management System?** - Finding documentation - layout of design control **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Product development is performed and documented in a uniform, complete way --> realized. Documentation management is implemented, reviews are recorded, signoffs are present --> realized **Official Response from Mike Gadus:** > Hi Schelte, Our team appreciates your positive feedback! Customers such as yourself are the lifeblood of everything we do at GG. Don't hesitate to reach to our customer success team with any specific feedback that you'd like to see us incorporate into the product. Thanks again! ### 45. Great SW! **Rating:** 4.5/5.0 stars **Reviewed by:** Verified User in Medical Devices | Mid-Market (51-1000 emp.) **Reviewed Date:** February 15, 2019 **What do you like best about Greenlight Guru Quality Management System?** - link between items - cristal clear inputs management - management of requirments (quality & regulatory) **What do you dislike about Greenlight Guru Quality Management System?** 1- It would be great to have the possibility to copy and past items 2- the real problem is just that sometimes you have to refresh the browser... so nothing really important **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** new product development ### 46. Design Controls lifesaver! **Rating:** 4.5/5.0 stars **Reviewed by:** Christie J. | Small-Business (50 or fewer emp.) **Reviewed Date:** April 24, 2018 **What do you like best about Greenlight Guru Quality Management System?** The design controls & risk management platform is beautiful. It saves a ton of time updating design controls and risk management inputs & outputs that would normally require multiple document updates with each change. This platform makes it so easy to document and capture the whole design & risk management process so easily. **What do you dislike about Greenlight Guru Quality Management System?** The only thing I would change is to allow documents to be "checked out," modified, and saved without having to save a revised local copy and uploading. **Recommendations to others considering Greenlight Guru Quality Management System:** Consider the business savings to having all document control, risk management, and design controls at your fingertips and not requiring paper solutions. This platform removes the frustration of giant excel documents that inevitably fail to be properly updated! **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** It usually takes a whole team to maintain design controls & risk management documentation, but this allows a smaller team to easily manage all these inputs from anywhere in easily half the time of a manual system. **Official Response from Carly McCarthy:** > Hey Christie, Thank you for the positive comments and feedback! Our team is glad to hear that our Design Controls and Risk Management platforms are benefiting you and your team. We hope you continue to share your successes with GG along with any additional feedback. ### 47. Wonderful eQMS and Team! **Rating:** 5.0/5.0 stars **Reviewed by:** Verified User in Medical Devices | Small-Business (50 or fewer emp.) **Reviewed Date:** April 26, 2018 **What do you like best about Greenlight Guru Quality Management System?** 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! **What do you dislike about Greenlight Guru Quality Management System?** A recommendation would be creating living logs (such as ASL, Customer Feedback, etc.) within Greenlight Guru instead of requiring each to be checked when it is updated. However, if there is a recommended improvement from our company or one of our clients, the Greenlight Guru team is more than willing to discuss the issue/concern with the team and work to improve the experience. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** The Greenlight Guru software keeps an 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 and easy control over QMS materials, and also holds individuals accountable. **Official Response from Carly McCarthy:** > Thank you for taking the time to share your positive remarks about GG! We encourage customers to share all of their successes and needs with our team, so we can further advance our software to the needs of medical device companies. I have relayed your feedback and recommendations to our Customer Success and Product teams. We greatly appreciate your valuable feedback! ### 48. OMEZA QMS **Rating:** 5.0/5.0 stars **Reviewed by:** Thomas G. | Small-Business (50 or fewer emp.) **Reviewed Date:** March 19, 2018 **What do you like best about Greenlight Guru Quality Management System?** OMEZA is an advanced wound care startup. 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. **What do you dislike about Greenlight Guru Quality Management System?** So far, very little. We made a mistake by assigning a very smart but inexperienced manager to use the greenlight.guru templates to populate the system initially. In retrospect, we would have been better off using someone with experience. That situation has now been resolved. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** Greenlight.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. ### 49. The Greenlight Guru Software is the handrail for Medical Device Development and Documentation **Rating:** 4.5/5.0 stars **Reviewed by:** Verified User in Chemicals | Enterprise (> 1000 emp.) **Reviewed Date:** April 09, 2018 **What do you like best about Greenlight Guru Quality Management System?** The link-based connectivity in the software is very much state of the art. This connectivity helps to keep control about the documentation steps. The DHF comes together nearly on its own. **What do you dislike about Greenlight Guru Quality Management System?** For people who are very much or if only used to a very linear and sequential paper based documentation systems might be initially a bit overwhelmed by the link-based software **Recommendations to others considering Greenlight Guru Quality Management System:** The software is continuously improving - into the exact right direction. Once I asked for certain aspects I was told that what I am asking for will be implemented at the next weekend. **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** It is the documentation of medical devices by a remote team what I like most. ### 50. My QMS is world class **Rating:** 5.0/5.0 stars **Reviewed by:** Dan H. | President & CEO, Medical Devices, Small-Business (50 or fewer emp.) **Reviewed Date:** May 11, 2018 **What do you like best about Greenlight Guru Quality Management System?** Best in class support, it is both software and service, I have an eQMS that rivals much larger companies in my industry **What do you dislike about Greenlight Guru Quality Management System?** Nothing specifically comes to mind, although as they grow I find it harder to get on their calendar **Recommendations to others considering Greenlight Guru Quality Management System:** recommend the software for all med device startups...you need Design Controls, you're risking your company if you don't **What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?** 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 Guru Quality Management System Discussions - [When do you think a planning tool/Calender can be incorporated in Greenlight Guru?](https://www.g2.com/discussions/when-do-you-think-a-planning-tool-calender-can-be-incorporated-in-greenlight-guru) - 1 comment, 2 upvotes - [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?](https://www.g2.com/discussions/markets-served) - 1 comment, 2 upvotes - [Will I have to pay for software upgrades?](https://www.g2.com/discussions/software-upgrade-costs) - 1 comment, 2 upvotes - [Is my organization's data and information safe in the cloud?](https://www.g2.com/discussions/cloud-data-security) - 1 comment, 2 upvotes - [How is the software licensed? Can I install it on my own server?](https://www.g2.com/discussions/deployment-licensing-model) - 1 comment, 2 upvotes - [View Greenlight Guru Quality Management System pricing details and edition comparison](https://www.g2.com/products/greenlight-guru-quality-management-system/reviews?page=8&utm_source=rewards-badge§ion=pricing&secure%5Bexpires_at%5D=2026-07-30+13%3A05%3A34+-0500&secure%5Bsession_id%5D=60e866e5-d10f-4700-8663-0ff03a034ec7&secure%5Btoken%5D=7d9fee2a87b81e3099549eafa210b019d1580f76ad19f1a47d0e909594e05685&format=llm_user) ## Greenlight Guru Quality Management System Integrations - [GitHub](https://www.g2.com/products/github/reviews) - [Google](https://www.g2.com/products/google-google/reviews) - [Jira](https://www.g2.com/products/jira/reviews) - [Microsoft 365](https://www.g2.com/products/microsoft365/reviews) ## Greenlight Guru Quality Management System Features **Quality Management** - Design Controls - Audit Management - Supplier Network Management - Risk Management **Nonconformance** - Conformance Records - CAPA - Change Management **Quality System** - Analytics & Reporting - Real-time Collaboration - Document Control - Quality Processes **Quality system** - Document Control - Collaboration - Analytics and Reports **Risk Management** - Assessments - Operational Risk - Supplier Evaluation **Inspection Management** - Templates - Workflows - Corrective Actions **Compliance** - Standards & Regulations - Permits - Certifications **Platform** - Integration - Security & Privacy - Mobile Access - Flexibility **Services** - Implementation - Training & Learning - Customer Support - Professional Services ## Top Greenlight Guru Quality Management System Alternatives - [Qualio](https://www.g2.com/products/qualio/reviews) - 4.4/5.0 (771 reviews) - [Octave Reliance (ETQ Reliance)](https://www.g2.com/products/octave-reliance-etq-reliance/reviews) - 4.3/5.0 (603 reviews) - [MasterControl Quality Management System](https://www.g2.com/products/mastercontrol-quality-management-system/reviews) - 4.3/5.0 (523 reviews)