Greenlight Guru Software

4.44 / 5 (54)

Our advisors have recommended this product 3 times in the last 30 days

About Greenlight Guru


GreenlightGuru is a cloud-based quality management solution designed specifically for the medical device industry. It provides premarket and post-market solutions which are Greenlight Go and Greenlight Grow. Key features include design control, risk management, audit management, complaint management, change management and training management.

Greenlight Go features design control that lets users maintain traceability. Users can create design control objects and attach documents with them. The solution offers auto document routing and revision control as well. Additionally, Greenlight Go allows users to view relationship between requirements, risks and verification tests.

Greenlight Grow features CAPA management that identifies and addresses the issues. Audit management allows users to manage tasks, follow-ups, communications and actions relating to audit findings. Final audit summaries can be created and shared. With nonconformance management, users can capture defect details such as part, quantity, failure type and severity.

Support is provided via phone, email, live chat, online training, podcasts and online documents.



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Supported Operating System(s):

Mac OS, Linux, Web browser (OS agnostic), Windows 10

54 Reviews of Greenlight Guru

Average User Ratings

Overall

4.44 / 5 stars

Ease-of-use

4.0

Value for money

4.5

Customer support

5.0

Functionality

4.0

Ratings Snapshot

5 stars

(33)

4 stars

(15)

3 stars

(4)

2 stars

(1)

1 stars

(1)

Likelihood to Recommend

Not likely

Very likely

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Showing 1-20 of 54 reviews

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November 2018

Jason from Nanofiber Solutions. Inc.

Company Size: 2-10 employees

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

November 2018

Great software to implement and maintain a medical device QMS

Overall experience is great. As a small medical device company, I can't imagine keeping up with our QMS requirements without a software platform like Greenlight Guru.

Pros

The design trace matrix makes the development process very straight forward and easy to use. The ability to link anything to each DTM component, and to link the DTM to the risk management module is great as well.

The document management and routing/approval features are also a great tool. We've been able to implement digital versions of most of our work forms, without the need to use third party document signature programs.

Cons

Sometimes there is a bit of a learning curve for the various modules that they release. It would be nice if a help/guide button was available for each to walk through the module step by step.

Response from Greenlight Guru of Greenlight Guru

Replied December 2018

Hey Jason: Thank you for the positive comments and feedback. Glad to hear that the ability to Link Anything is positively impacting your Design Control/Risk efforts and that built in workflows with eSignatures are simplifying processes. As it relates to your feedback on getting up to speed on how to use new functionality, know that we've heard you and are actively working on a solution to help you get up to speed on how to use new functionality and what's changed in app that I believe you will be pleased with. Don't ever hesitate to share additional feedback like this with us by phone, chat, or email at customer.success@greenlight.guru

November 2016

Matthew from MYOLYN, LLC

Company Size: 2-10 employees

Review Source: Capterra


Ease-of-use

4.0

Value for money

5.0

Customer support

5.0

Functionality

3.0

November 2016

Medical device startup's experience

greenlight.guru is the perfect software solution for a medical device startup company looking to get a quality management system, compliant with both the FDA's and ISO's requirements, up and running. It also holds your hand through the design control and risk management process, which is especially valuable for a company without much experience going through these processes. We didn't need to hire a quality manager because of how helpful this software is, a fact that alone makes it worth the price.

Pros

The structure of the design control and risk management modules guide you through the process of documenting both. Especially great for someone who's never gone through these processes before.

Cons

While it contains the core of what's necessary for a QMS, it lacks a lot of functionality that a larger business would need, making it likely that we'll outgrow it quickly.

Response from greenlight guru of Greenlight Guru

Replied December 2016

Hi Matthew, we appreciate you taking the time to write your review of our software. That's great to hear greenlight.guru has enabled you to delay the hire of a full time quality manager. Per your comment regarding the feature set needed for a larger business, we'd love to hear your specific recommendations if you have them so that we can take them into account as we continue to execute on our roadmap. You can reach out to us and provide your feedback directly to customer.success@greenlight.guru. To date, we have several larger medical device companies with multiple products and hundreds of employees that are successful using the platform.

December 2018

Stephen from Genetesis, Inc

Company Size: 11-50 employees

Review Source: Capterra


Ease-of-use

5.0

Customer support

5.0

Functionality

5.0

December 2018

Great product, continuously improving!

We needed an eQMS system, and a method of tracking our project progress. Greenlight.Guru does that in a fluid, comprehensive manner - making my life far easier.

Pros

Greenlight.guru successfully ties risk analysis to design controls, providing a method of reviewing all of the design or component by component. All of the associated documents can be linked to Design items, weaving in the entire story behind a particular product. I have not found a similar product, and have never seen a more dedicated team. Issues that I have encountered, they resolve in a thoughtful, forward-thinking manner.

Cons

In the early usage, there were difficulties finding the documents I wanted. They have recently added the linking functionality on the document side, which allow related items to be tied to each other.

Response from Greenlight Guru of Greenlight Guru

Replied December 2018

Hey Stephen, Thank you for the kind feedback. The team at GG is dedicated to assuring the success of our customers. Glad to hear the linking functionality is benefiting your efforts. Additionally, I think you'll be pleased with upcoming efforts we are making to further simplify document management starting with the debut of Document Views in our December release. Keep the feedback coming.

October 2018

Penny from REGSolutions, LLC

Company Size: 2-10 employees

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

October 2018

Recommendation for Greenlight Guru as your medical device eQMS solution

Ease of integration of design control with risk management is a breeze. No more tedious xcell spreadsheets!!

Pros

I like that this medical device software is built by medical device professionals and not just SW developers who don't even know what a medical device is! this SW is built to match the processes I have been doing now for over 35 years - document control, design control, capa, internal audits, etc. Both modules GO and GROW are on spot to meet the regulatory requirements.

Cons

As with any SW we have to be methodical in our naming conventions as we load documents. Its all about setting rules as a company so that SMART naming is followed which makes the search mechanisms more effective.

Response from Greenlight Guru of Greenlight Guru

Replied November 2018

Hi, Penny. Really appreciate your feedback and comments. Did you know that all documents are assigned a unique ID when added now? Yes, there is still a need to apply some intelligence with document naming and description. Those attributes (regardless of system) are key.

December 2018

Sarah from Omeza

Company Size: 2-10 employees

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

December 2018

A god-send of a QMS

As a new medtech company with many different product and differing product regulations, we are pleased to have Quality Management as one of our easiest tasks - which is rare to say. The team is fantastic and abundantly helpful, the system is quick to learn and easy to use, and the support you get standing the system up from scratch if you don't already have a system in place is great. We needed Quality "handled" so we could focus on the trickier parts of our company - Greenlight Guru was and is that perfect solution.

Pros

With GG, it is structured and organized to not just allow compliance, it promotes compliance - meaning using the software as it is built easily documents for product design/dev and ongoing quality req'ts. It's easy to use and navigate, quick to learn even for lay people, and makes our QMS regulatory headache-free.

Cons

The team keeps making improvements, and I'm looking forward to a bit of a better structure to the large document repository. It is searchable, tagable, and sortable easily, but there are a few other ways that they could organize things so you can find something quickly.

Response from Greenlight Guru of Greenlight Guru

Replied December 2018

Hi Sarah, The team at GG greatly values your feedback and we appreciate you taking the time share your experience working with our software and team. Glad to hear you are excited about the upcoming enhancements to Advanced Document Management with with debut of Document Views in our December 2018 release. We strive to simplify quality management for medical device companies of all sizes, and welcome any future feedback or enhancements ideas.

December 2018

Tonia from Lucerno Dynamics

Company Size: 2-10 employees

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

December 2018

Sleek Medical Device QMS Software with a great Team!

Pros

The system workflow is intuitive and easy-to-use right out of the box. We currently utilize the document management system and the module allows for quick uploads, document organization and ease of finding documents.

The Greenlight Guru team behind the software works with you to meet your business objectives. Additionally, the have a strong customer focus and really listen to the voice of the customer.

Cons

The search function can be a struggle at times; would really like the opportunity to filter further.

Response from Greenlight Guru of Greenlight Guru

Replied December 2018

Hi Tonia - Thank you for sharing the positive feedback with our team. Our team is happy to hear that you value the turn-key nature of our solution for medical device companies. We strive to simplify quality for our customers and removing the burden of assuring documentation is compliant to regulatory standards is an essential piece in that effort. Please know that we hear your feedback regarding the need to find things faster within the system. I believe that you'll find the debut of Document Views in our December 2018 to be a starting point in helping you achieve this as we further enhance search and filtering functionality.

December 2016

Grant from Hansei Consulting LLC

Review Source: Capterra


Ease-of-use

4.0

Value for money

4.0

Customer support

4.0

Functionality

4.0

December 2016

Greenlight Guru for OtoNexus

I am a consultant, working with OtoNexus, an early-stage medical device company, on the implementation of their Quality Management System (QMS). We advised them to consider deploying Greenlight Guru for this purpose, and they are in the initial stages of doing so. The Document Management features of the software appear to be thorough, well thought out and useable. Obviously, the flexible routing and detailed history features for document review and sign-off, and compliance with Part 11, are very helpful and key to the success of any medical device company's QMS. The tutorial on the Product Development module, which is based on 14971 risk management principles, seems like it will be an excellent tool. Unfortunately, the client is a bit behind in utilizing it, and wants some other project management features implemented that, frankly, are a bit beyond the scope of this type of software tool. Customer support in general has been excellent. We have noted, however, that when product feedback is given, although the response to a question or issue is timely, there is often a defensive tone that comes across. An example of this was when there was a change to the software, which caused a conflict with login using a browser that had worked fine previously. Yet, we were not notified of this change, and once we found the issue, were told to update our browser. This software, like any other, is imperfect, and can and should be continuously improved. Overall, my initial impressions are that this is an excellent software tool for implementing a QMS at a medical device company.

Response from Greenlight Guru of Greenlight Guru

Replied December 2018

Hi Grant, thank you for taking the time to write your review of greenlight.guru. You input, and the feedback from all our customers is very important to the continuous improvement of our software. Since your original feedback on 12/1/16, we've evolved our internal release processes and documentation in order to assure changes such as this are better communicated with customers. Thanks again for your feedback and partnership.

November 2016

Douglas from CardioQuip

Company Size: 2-10 employees

Review Source: Capterra


Ease-of-use

3.0

Value for money

3.0

Customer support

5.0

Functionality

3.0

November 2016

Good to Great

We really like using Greenlight guru and we believe that it is a service that all businesses in the medical industry should be using. However, when we signed on we were promised the addition of many various features. These features have not been added in the nearly two years we have been involved with Greenlight. I come from a software background and understand that things sometimes have to be placed on hold in order to fix more pressing issues. However, so far the additions that have been made have made greenlight more difficult to use rather than easier. We look forward to seeing some of the new features that have been promised to us in the near future.

Pros

It is the only Medical device management software on the market. Also, it allows us to centralize our numerous documents and other design records together in one place.

Cons

Limited functionality. We are still having to come up with our own solutions for numerous things that we believe were we able to use Greenlight it would immensely alleviate some of our work load.

Response from greenlight guru of Greenlight Guru

Replied October 2018

Hi, Douglas. It is great to work with you and your team. Since you left this comment, Greenlight Guru has added a ton of post-market functionality to help you better manage quality events. Now that you are using these features, how are things going?

November 2016

Michael from GCMI

Company Size: 51-200 employees

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

4.0

November 2016

Great and Developing Document & Design Controls

GreenLight.Guru (GLG) is a terrific tool that solves multiple issues - design controls, document controls, and compliance. Perhaps just as valuable is an unending stream of blog posts and educational articles from the GLG staff. Their goal is to help users of their software (and, frankly, just about everyone else) adopt best practices in medical device design and maintain compliance during the product development process and beyond. The system is not very intimidating, but still requires some sophistication to use properly. That being said, it enables a single person to do the work of several people, which is extremely efficient for a small or start-up company. My current "complaint" is that our GLG installation does not send email notifications about tasks or documents to review. This would be very beneficial.

Pros

Easily allows for document control in a compliant system for medical device development

Cons

I like traditional interfaces with document lists that look like a "Window" rather than highly formatted presentations. Give me simple presentation.

Response from Greenlight Guru of Greenlight Guru

Replied December 2018

Hi Michael, our team appreciates you taking the time to review our software and provide your feedback. I'm happy to share that functionality for automated e-mail notifications are now available. Additionally, individual users can modify notifications to their liking. Please don't hesitate to provide additional feedback. Our team is actively listening to the evolving needs of our customers as we develop new functionality.

November 2016

Jeff from Recovery Force

Company Size: 2-10 employees

Review Source: Capterra