--- 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

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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

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## 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)

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 ![Verified User in Medical Devices](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User in Medical Devices")
AM

Verified User in Medical Devices

Small-Business (50 or fewer emp.)

5/15/2023

"Quality Specialist - In GLG every day"

4/5

What do you like best about Greenlight Guru Quality Management System?

I enjoy that I can easily upload documents and sort them using attributes. It has helped a lot when it comes to organization. Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

I think the searching function in GLG is sub-par. You can type in the exact title of a document, and it still won't be the top result. The training space could also use work. Review collected by and hosted on G2.com.

What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?

The document and change space are great workflows that allow us to easily record procedures and records and route certain types of documents for approval. Which is helpful with lots of people utilizing remote working more and more. Review collected by and hosted on G2.com.

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9/14/2023
Current UserValidated ReviewerIncentivizedSource: Seller invite

TJ

Tabitha J.

Small-Business (50 or fewer emp.)

2/21/2023

"User Friendly and Great, Knowledgeable Customer Support"

4.5/5

What do you like best about Greenlight Guru Quality Management System?

There are three things that I like the most about Greenlight Guru:

1) Searchability - the search feature is very comprehensive and allows for a very well-rounded view of what's available on the platform

2) Alignment of Design Control and Risk Matrixes - I appreciate how the software emphasizes linking the design control matrix and the risk matrix since they, by default, must be intertwined (according to the regulation). The software allows that to happen seamlessly and hits the mark on that requirement.

3) Consistency: I appreciate how the audit, customer feedback, CAPA, and nonconformance workflow are not dramatically different. This allows for easy application and assists the user's learning curve. Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

There are a few things I dislike about GG:

1) The "Notes" field in all workflows is not editable once you submit notes to an investigation stage in any workflow.

2) The Analytics page still does not produce any relevant information. I'm unsure if it's because I don't have much data to analyze, but all the analytic information on that page does not help me at this time.

3) Quite a few notification emails: A common feedback I get from the team is how many emails they get a day from GG. Though I know we apply notification preferences, the selections don't have much of an explanation as to how your notifications will change. Review collected by and hosted on G2.com.

What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?

Training Management: Greenlight is currently saving me several hours of what I used to put towards of collecting, tracking, and logging people's training.

Electronic Signatures: Greenlight permits all users to electronically sign documents which prevents document management personnel from hunting down and threatening individuals for their signature. Instead, the program automatically notifies you of a document pending your approval.

Logs: Greenlight removes the need for logs such as CAPA log, Audit Log, Change Log, Complaint Log because the workflows establish and track that information for you. Review collected by and hosted on G2.com.

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Current UserValidated ReviewerIncentivizedSource: G2 invite on behalf of seller

EF

Edward F.

QARA

Small-Business (50 or fewer emp.)

3/3/2021

"User friendly EQMS software which listen to the customers needs"

4.5/5

What do you like best about Greenlight Guru Quality Management System?

User friendly interface, very good customer support and they go out of their way to resolve queries in a timely and professional way. The software is ideal for small to medium enterprises and start ups and continues to evolve in a positive direction. A lot of work is done to ensure your feedback is listened to and suggestions are always welcomed and often implemented to improve the software. The software is also validated after each release and these reports are made readily available which is very helpful. Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

Occasional bugs but these are usually promptly resolved. Some work involved with the validation reports, which occur perhaps too often. Especially the maintenance releases. Review collected by and hosted on G2.com.

What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?

Perfect for easily finding documentation during audits and the general day to day management of the quality management system. The approval process is a very effective way of showing documentation was appropriately reviewed and overall the move away from a paper based QMS to an EQMS has a whole array of benefits. Review collected by and hosted on G2.com.

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2/15/2023
Current UserValidated ReviewerSource: Organic

 ![Verified User in Medical Devices](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User in Medical Devices")
AM

Verified User in Medical Devices

Small-Business (50 or fewer emp.)

8/10/2023

"Putting a Quality Agreement in place"

4/5

What do you like best about Greenlight Guru Quality Management System?

Overall great eQMS with good templates to help getting startups set up. The customer service is fantastic, it is very apparent that GG is dedicated to helping customers and provide great service. Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

Lack of customization for modules and creation of templates within GG. I am aware this will add additional complicaitons and could lead to GG not being as smooth as it is today. Also pricing is on the higher end. Review collected by and hosted on G2.com.

What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?

As a Medical Device Manufacturer we are required to implement ISO 13485 processes. GG helps with that and is also compliant to Part 11 of the CFR. Review collected by and hosted on G2.com.

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Current UserValidated ReviewerIncentivizedSource: Seller invite

 ![Verified User in Medical Devices](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User in Medical Devices")
AM

Verified User in Medical Devices

Mid-Market (51-1000 emp.)

11/20/2023

"We have been using Greenlight Guru for 18 months"

5/5

What do you like best about Greenlight Guru Quality Management System?

Greenlight Guru's workspaces are well thought out and comprehensive. Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

As Greenlight Guru is so comprehensive there is a lot of training needed to prepare new users despite it being easy to use. 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 was chossen to make efficencies in how our company develop new products. Review collected by and hosted on G2.com.

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Current UserValidated ReviewerIncentivizedSource: G2 Gives Campaign

 ![Verified User in Medical Devices](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User in Medical Devices")
AM

Verified User in Medical Devices

Mid-Market (51-1000 emp.)

6/28/2023

"Good experience in customer service and document submittal , but to be developed in report"

3/5

What do you like best about Greenlight Guru Quality Management System?

1. Really great experience in Customer service from customer manager

2.Simply operation in document submittal Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

Below function are automatically/available for most of legacy system(s) I used, but it is not available in Guru. Takes a lot of time to do by manually.

Training:

1. Overdue training mail cannot be copied to user's manager automatically

2. The New/Revised Procedure Training is an automated process in our legacy system, it will automatically trigger training course once new revision is published and replace supersede file in pending training.

but all those have to be conducted by manually in Guru.

Change Management:

1. Can create a group for specific document type, then select the team every time, if I submit the same type.

(e.g. fixed 7 persons in a group for artwork of BU1)

Some systems can route document for reviewer(s) automatically based on pre-settings

But in Guru, we are not allowed to select reviewer(s) by group. We have to add reviewer one by one in “TEAM” every time.

Report

1. Cannot see Who is current approver in document list or change order list, have to search CO one by one to check.

2. Cannot see title, department, manager and group in user list Review collected by and hosted on G2.com.

What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?

Bulk upload service is much help and save time for migration from our legacy system. Review collected by and hosted on G2.com.

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Response from Kaitlyn Sawin of Greenlight Guru Quality...

[Editedit](https://www.g2.com/survey_responses/greenlight-guru-quality-management-system-review-8257963/official_response/edit)

Thanks so much for providing a review of Greenlight Guru! We are thrilled to hear that you are enjoying your experience, especially with your Customer Success Manager.

The product feedback you have provided has been captured for our team and we are happy to share improvements to our Training Workspace beginning in Septemeber 2023 that may improve the outlined experience.

Should you have any additional feedback to share, do not hesitate to pass along to your CSM!

Validated ReviewerSource: Organic

 ![Verified User in Medical Devices](/assets/icons/anonymous-avatar-purple-4ae1032bdb50ee5682003170c8184aee790d25958bd397abbd384ba52c596a7b.svg "Verified User in Medical Devices")
AM

Verified User in Medical Devices

Mid-Market (51-1000 emp.)

2/21/2023

"Powerful and User-friendly eQMS"

4/5

What do you like best about Greenlight Guru Quality Management System?

Document management space makes searching for a document very easy instead of memorizing doc IDs. The interface is very user-friendly, navigating is quite easy. the customer support is fantastic! Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

The training space does not contain an automated training matrix space, requires manual tracking in spreadsheet which is not scalable for fast-growing companies. improved Jira integrations with all quality event spaces Review collected by and hosted on G2.com.

What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?

Greenlight is very proactive with customer feedback to make our experience very easy-going. GGs linkages and traceability features help our team keep things connected and make auditing very smooth. Review collected by and hosted on G2.com.

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8/7/2023
Current UserValidated ReviewerIncentivizedSource: G2 invite on behalf of seller

KW

Kristen W.

Small-Business (50 or fewer emp.)

2/14/2023

"Great platform to walk new companies through to conformance!"

4.5/5

What do you like best about Greenlight Guru Quality Management System?

Greenlight is great because the platform itself has so many useful tools embedded in one place. You can have your design control matrix, risk matrix, customer feedbacks, nonformances, CAPAs and documents in one easy to view platform. Not only is the user interface clean and clear, but the staff are extremely knowledgeable and willing to help! Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

The downside that I have noticed is that there are some things that could be better automated, especially for smaller companies where creating multiple documents at a time could be potentially done in a more efficient way. Review collected by and hosted on G2.com.

What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?

Having an eQMS really helps to speed up documentation, with limited user interaction, allowing our company to remain in compliance and stick to our processes. I can't imagine having a paper QMS to handle all our documentation. Review collected by and hosted on G2.com.

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Current UserValidated ReviewerIncentivizedSource: G2 invite on behalf of seller

 ![Ted R.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Ted R.")
TR

Ted R.

Small-Business (50 or fewer emp.)

8/10/2023

"Novel platform with streamline functionality"

5/5

What do you like best about Greenlight Guru Quality Management System?

It is easy to use and logical. The platform is also 21 CFR 11 compliant and majoritily validated by GreenLight. Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

There is no complaint module. I am forced to use the Customer Feedback module for complaints :/ Review collected by and hosted on G2.com.

What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?

Good documentation practices. Review collected by and hosted on G2.com.

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Current UserValidated ReviewerIncentivizedSource: Seller invite

 ![Marcela G.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Marcela G.")
MG

Marcela G.

Specialist, Clinical Project Manager

Research

Mid-Market (51-1000 emp.)

8/14/2023

"I like the training"

4/5

What do you like best about Greenlight Guru Quality Management System?

It is easy to complete the trainings is a very friendly experience. Review collected by and hosted on G2.com.

What do you dislike about Greenlight Guru Quality Management System?

I don't like so much the audit modules, are not so easy to understand. Review collected by and hosted on G2.com.

What problems is Greenlight Guru Quality Management System solving and how is that benefiting you?

The trainings are automatic, and it's straightforward to be traceable. Review collected by and hosted on G2.com.

Show More

4/22/2024
Current UserValidated ReviewerIncentivizedSource: G2 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
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## 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)

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##### 
##### 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)

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