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[

Greenlight Guru Quality Management System

](/products/greenlight-guru-quality-management-system/reviews)

(411)4.5/5

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.

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 ![Assed H.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Assed H.")
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[Assed H.](https://www.g2.com/users/e3b21cb5-392e-431d-a0c6-7fb1def739eb "Assed H.")

•

almost 5 years ago

Technical Writer

Technical Writer

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[
# Are there plans to integrate a review workflow into the software to allow review comments to be added to documents when in draft and before approval? As well as the ability to check in and check out documents when in draft to make changes/edits according to any review comments left by reviewers.
](/discussions/are-there-plans-to-integrate-a-review-workflow-into-the-software-to-allow-review-comments-to-be-added-to-documents-when-in-draft-and-before-approval-as-well-as-the-ability-to-check-in-and-check-out-documents-when-in-draft-to-make-changes-edits-according-t)

[

Quality Management (QMS)

](https://www.g2.com/tags/quality-management-qms)[

Medical QMS Software

](https://www.g2.com/tags/medical-qms-software)

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•

almost 5 years ago

Quality Systems Specialist

Quality Systems Specialist

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[
# Can we get the assistance in understanding the CAPA and Auditing module in the GG? Also, we have user feedback for the training module, can we get scheduled for the interactive session, that way, we can talk to you about the inconveniences we are currently having with the training module?
](/discussions/can-we-get-the-assistance-in-understanding-the-capa-and-auditing-module-in-the-gg-also-we-have-user-feedback-for-the-training-module-can-we-get-scheduled-for-the-interactive-session-that-way-we-can-talk-to-you-about-the-inconveniences-we-are-currently-hav)

[

Quality Management (QMS)

](https://www.g2.com/tags/quality-management-qms)[

Medical QMS Software

](https://www.g2.com/tags/medical-qms-software)

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G2

Verified User

•

over 5 years ago

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[
# How is the best way to create a Training Matrix within the system?
](/discussions/45477-how-is-the-best-way-to-create-a-training-matrix-within-the-system)
One of the features I would like to see is the ability to create training matrices within the system. Currently we use a paper training sheet for each employee. It is very challenging to update when a new SOP comes out. Having the ability to integrate the matrix into the training module would be... [Read more](/discussions/45477-how-is-the-best-way-to-create-a-training-matrix-within-the-system)

[

Quality Management (QMS)

](https://www.g2.com/tags/quality-management-qms)[

Medical QMS Software

](https://www.g2.com/tags/medical-qms-software)

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•

over 5 years ago

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[
# When do we get ERP integration?
](/discussions/45476-when-do-we-get-erp-integration)
I would like to see an ERP integration so that transfer of product is easy.

[

Quality Management (QMS)

](https://www.g2.com/tags/quality-management-qms)[

Medical QMS Software

](https://www.g2.com/tags/medical-qms-software)

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•

over 6 years ago

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[
# Traceability Matrix - Multi user?
](/discussions/23926-traceability-matrix-multi-user)
Does your Traceability Matrix have a Multi-user function? Can we work at the same time in one Traceability?

[

multiuser

](https://www.g2.com/tags/multiuser)[

Traceability Matrix

](https://www.g2.com/tags/traceability-matrix)[

Quality Management (QMS)

](https://www.g2.com/tags/quality-management-qms)[

Medical QMS Software

](https://www.g2.com/tags/medical-qms-software)

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G2

Verified User

•

over 7 years ago

Posted by Greenlight Guru Quality Management System

Posted by Greenlight Guru Quality Management System

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[
# Can I use Greenlight Guru’s quality management software if I am already working with a QA/RA Consultant?
](/discussions/consulting-bd342121-e868-4abb-837a-adfe13dffb6f)
Consulting

[

Quality Management (QMS)

](https://www.g2.com/tags/quality-management-qms)[

Medical QMS Software

](https://www.g2.com/tags/medical-qms-software)

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•

over 7 years ago

Posted by Greenlight Guru Quality Management System

Posted by Greenlight Guru Quality Management System

More Options
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[
# How does Greenlight Guru help my company achieve regulatory compliance?
](/discussions/compliance-6835a5e8-d534-404f-82e9-036aec704edf)
Compliance

[

Quality Management (QMS)

](https://www.g2.com/tags/quality-management-qms)[

Medical QMS Software

](https://www.g2.com/tags/medical-qms-software)

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\<0\>0\>Upvotes

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1 Comment

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over 7 years ago

Posted by Greenlight Guru Quality Management System

Posted by Greenlight Guru Quality Management System

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[
# How do I migrate my existing QMS controlled documents and processes into Greenlight Guru ?
](/discussions/data-process-migrations)
Data & Process Migrations

[

Quality Management (QMS)

](https://www.g2.com/tags/quality-management-qms)[

Medical QMS Software

](https://www.g2.com/tags/medical-qms-software)

* * *

\<0\>0\>Upvotes

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1 Comment

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•

over 7 years ago

Posted by Greenlight Guru Quality Management System

Posted by Greenlight Guru Quality Management System

More Options
- 

[
# How long does onboarding take?
](/discussions/onboarding-002736b5-9603-4eb5-b4b5-2525750e4dc0)
Onboarding

[

Quality Management (QMS)

](https://www.g2.com/tags/quality-management-qms)[

Medical QMS Software

](https://www.g2.com/tags/medical-qms-software)

* * *

\<0\>0\>Upvotes

* * *

1 Comment

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•

over 7 years ago

Posted by Greenlight Guru Quality Management System

Posted by Greenlight Guru Quality Management System

More Options
- 

[
# Do you offer onboarding services?
](/discussions/onboarding-fc751470-e95b-4860-aeaf-b33cdfbeee2d)
Onboarding

[

Quality Management (QMS)

](https://www.g2.com/tags/quality-management-qms)[

Medical QMS Software

](https://www.g2.com/tags/medical-qms-software)

* * *

\<0\>0\>Upvotes

* * *

1 Comment

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## Top Contributors in Greenlight Guru Quality Management System

1

MG

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### [Mike G.](https://www.g2.com/users/1b7fa950-6464-420c-b0a5-33ef27027508 "Mike G.")

9 pts

2

 ![Assed H.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Assed H.")
AH

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### [Assed H.](https://www.g2.com/users/e3b21cb5-392e-431d-a0c6-7fb1def739eb "Assed H.")

Technical Writer

2 pts

3

 ![Karina L.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Karina L.")
KL

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### [Karina L.](https://www.g2.com/users/5aa3310c-f92f-4832-a39b-c1a0aa84dbaa "Karina L.")

Quality and Regulatory Affairs Director

2 pts

4

 ![Mike C.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Mike C.")
MC

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### [Mike C.](https://www.g2.com/users/ee0b5122-f21c-4f3a-ace7-6b7bb6e1d57b "Mike C.")

Sr. Account Executive

1 pt

5

 ![Amy H.](/assets/transparent-ad5be28fbcd25b7b08d2cebe1d957125437fb5407d75ee717965ad22c8808791.gif "Amy H.")
AH

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### [Amy H.](https://www.g2.com/users/eca1fb2b-39ee-458c-a9a3-8ce41d0acd8c "Amy H.")

1 pt