Greenlight Guru

Medical Device QMS Software


4.5 / 5
56 reviews

Who Uses This Software?

Greenlight Guru is the perfect solution for medical device companies looking to save time and money bringing their product to market. Our customer include QA/RA roles, Engineers and Executives alike.


Average Ratings

56 Reviews

  • 4.5 / 5
    Overall

  • 4.5 / 5
    Ease of Use

  • 5 / 5
    Customer Service

Product Details

  • Starting Price
    Not provided by vendor
  • Free Demo
  • Deployment
    Cloud, SaaS, Web
  • Training
    Documentation
    Webinars
    Live Online
  • Support
    Online
    Business Hours
    24/7 (Live Rep)

Vendor Details

  • Greenlight Guru
  • greenlight.guru
  • Founded 2013
  • United States

About Medical Device QMS Software

Greenlight Guru is the only electronic Quality Management Software (eQMS) designed by medical device professionals specifically to meet the unique needs of medical device companies. Our comprehensive, out-of-the-box solution is based on the latest FDA and ISO standards and best practices, all of which are meticulously woven into every feature within the cloud-based platform. Join hundreds of other medical device companies working with us to shift your focus from just compliance to True Quality.


Medical Device QMS Software Features

  • Audit Management
  • Complaint Management
  • Compliance Management
  • Corrective and Preventive Actions (CAPA)
  • Defect Tracking
  • Document Control
  • Equipment Management
  • ISO Standards Management
  • Maintenance Management
  • Risk Management
  • Supplier Quality Control
  • Training Management
  • Audit Management
  • CAPA Planning
  • Change Management
  • Complaint Management
  • Incident Management
  • Nonconformance Tracking
  • Quality Control
  • Risk Management
  • Root Cause Analysis
  • Training Management

Medical Device QMS Software Reviews Recently Reviewed!


Great software to implement and maintain a medical device QMS

Nov 05, 2018
5/5
Overall

5 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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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.

Overall: 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.

Vendor Response

by Greenlight Guru on December 17, 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

Medical device startup's experience

Nov 15, 2016
5/5
Overall

4 / 5
Ease of Use

3 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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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.

Overall: 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.

Vendor Response

by Greenlight Guru on December 05, 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.

Great product, continuously improving!

Dec 12, 2018
5/5
Overall

5 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support
Likelihood to Recommend: 10.0/10 Not
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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.

Overall: 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.

Vendor Response

by Greenlight Guru on December 17, 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.

Recommendation for Greenlight Guru as your medical device eQMS solution

Oct 23, 2018
5/5
Overall

5 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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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.

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

Vendor Response

by Greenlight Guru on November 01, 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.

Capterra loader

A god-send of a QMS

Dec 11, 2018
5/5
Overall

5 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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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.

Overall: 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.

Vendor Response

by Greenlight Guru on December 14, 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.

Sleek Medical Device QMS Software with a great Team!

Dec 04, 2018
5/5
Overall

5 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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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.

Vendor Response

by Greenlight Guru on December 14, 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.

Greenlight Guru for OtoNexus

Dec 01, 2016
4/5
Overall

4 / 5
Ease of Use

4 / 5
Features & Functionality

4 / 5
Customer Support

4 / 5
Value for Money

Comments: 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.

Vendor Response

by Greenlight Guru on December 17, 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.

Good to Great

Nov 29, 2016
4/5
Overall

3 / 5
Ease of Use

3 / 5
Features & Functionality

5 / 5
Customer Support

3 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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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.

Overall: 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.

Recommendations to other buyers: The security stuff (although we have been told has to be the way it is to comply with FDA standards) is tedious. Is there not a better solution that is still within FDA standards?

Vendor Response

by Greenlight Guru on October 12, 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?

Great and Developing Document & Design Controls

Nov 15, 2016
5/5
Overall

5 / 5
Ease of Use

4 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 9.0/10 Not
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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.

Overall: 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.

Vendor Response

by Greenlight Guru on December 14, 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.

Jeff Schwegman Review

Nov 17, 2016
4/5
Overall

4 / 5
Ease of Use

3 / 5
Features & Functionality

4 / 5
Customer Support

3 / 5
Value for Money
Likelihood to Recommend: 8.0/10 Not
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Pros: The dashboard showing User Needs; Design Inputs; Design Outputs; Design Verification; Design Validation all on one screen. I also like the Doc control capabilities

Cons: Risk Management section is cumbersome to use

Overall: Overall my experience is positive. I like having the User Needs through Design Validation all on one dashboard in front of me. The Risk Management section is a little cumbersome to use at this point. I'm looking forward to new modules like ECO etc.

Recommendations to other buyers: I'm anxiously awaiting the ECO module and the automatic approver notification (so I don't have to manually email the next approver to sign a document)

Vendor Response

by Greenlight Guru on December 14, 2018

Hello Jeff, we appreciate you taking some time to write your review of our software.

Your feedback regarding the risk management module has been heard and we believe you will be very excited about the changes coming with our risk 2.0 release.

As it relates to your feedback regarding automatic notifications, we are pleased to share that this functionality is now available to further enhance your team's experience when routing documents through approval workflows.

Glad to hear your overall experience has been positive and look forward to delivering on your feedback regarding the risk matrix.

Initial Review

Apr 01, 2019
5/5
Overall

5 / 5
Ease of Use

5 / 5
Features & Functionality
Likelihood to Recommend: 10.0/10 Not
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Pros: We set out to implement a QMS for our small Medical Device Company. To date, Greenlight Guru (GG) has proven to be an excellent choice. We are only a few months into the process but I see no problem in staying on track. Their support has been fantastic! We are ahead of schedule and I have been pleased with the quality of support we are getting. Our company has had a few false starts with consulting firms, GG is making the process enjoyable.

Cons: GG offers a package of procedure templates that make the job much easier. With that, the formatting and wording of the templates could be a tad more uniform. With that said, it is understandably difficult to make a universal set of templates that fit everyone's needs. I find the template package well done on that front.

Overall: To date, GG has been an excellent partner in the implementation of an otherwise difficult system.

Vendor Response

by Greenlight Guru on April 10, 2019

Hey Art -

Our team greatly appreciates you taking the time to provide your feedback. We are thrilled to hear that our Customer Success team's Fanatical Support has jumpstarted your implementation process, while also making it an enjoyable experience.

We appreciate your feedback regarding our procedure templates, as well. Please feel free to share your ideas for improvement with a member of our team.

Thanks again - Glad to have you as a customer of Greenlight Guru!

Focus on the work - not the admin!

May 29, 2019
5/5
Overall

5 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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Pros: It sped up document control work flow and freed up the QA department's time to focus on validations and regulatory updates.

Cons: We can't think of anything at this time.

Overall: It changed the way we documented risk related to the products. We streamlined our QMS and this helped us to come together as a team. Design reviews are easily assigned; change control tasks are set and executed - no more separate emails and phone calls to follow up - Greenlight does the nagging for you.

Vendor Response

by Greenlight Guru on June 04, 2019

Hey Dalene -

Thanks for sharing your positive feedback about our software!

It is great to hear that our software has freed up your team's time to focus more on strategic and value-add activities, instead of the manual labor of overseeing a QMS.

If you ever have any questions or would like to provide us with more feedback, please do not hesitate to contact us.

Diabeloop_MChassouant feedback

Nov 29, 2016
4/5
Overall

4 / 5
Ease of Use

3 / 5
Features & Functionality

5 / 5
Customer Support

3 / 5
Value for Money
Likelihood to Recommend: 7.0/10 Not
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Pros: electronical signature and the fact that my document is blocked one published.

Cons: I would like to be able to put my document in file, not only have routing, published etc etc but QMS, DHF etc etc. I know I can do it with the search system but then I need my documents to have many tags...

Overall: It is currently difficult to rate your system for me because Diabeloop managers decided not to use all fonctionnalities included within Greenlight-guru. If I may suggest something, I would like to have a less sensitive search system. Because right now if I don't know the exact name of my document, the search system will not detect it!

Recommendations to other buyers: make the search system a bit less sensitive, have a email system to email the user who needs to review or approve a document,

Vendor Response

by Greenlight Guru on December 14, 2018

Hi, Marion -

Thank you for the feedback. A while back, we debuted robust search document search functionality to address the use case you described.

Glad to hear that your team has started collaborating and using the system more in 2018.

Greenlight Guru does what it says on the tin....

Nov 15, 2016
5/5
Overall

4 / 5
Ease of Use

4 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 9.0/10 Not
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Pros: Aesthetically pleasing as well as practical and easy to use.

Cons: The risk and design modules have been difficult at times to use - the risk matrix is not easily maintained as a living record, e.g when a risk is mitigated and the scoring reduced.

Overall: Green light Guru has been an invaluable resource not only in the set up an electronic QMS but in the advice available in the form of webinars and podcasts and someone who is new to the world of Quality and Regulatory requirements.

Vendor Response

by Greenlight Guru on December 05, 2016

Hi Lizze, thank you very much for taking the time to review our software.

We're glad to hear we've been able to live up to the promises made through our website and marketing.

Your input, and the feedback we receive from all our customers is very important to us. That being said, we appreciate you comments regarding the risk matrix, and they have been added to our backlog.

Your feedback will be considered as we look to release our risk 2.0 module.

Great solution for medical device companies

Nov 15, 2016
5/5
Overall

4 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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Pros: The fact that it automates the process instead of just storing documents.

Cons: It would be great to have email notifications when you have an assigned activity.

Overall: GreenLight.guru has made implementing our quality system a manageable effort. We have likely saved half the effort and tens of thousands of dollars by using it for our first FDA submission.

Vendor Response

by Greenlight Guru on December 14, 2018

Hello Ross, thank you very much for taking the time to write your review.

We really appreciate your input and feedback.

We're happy to hear greenlight.guru has helped save you both time and dollars on your first FDA submission.

Additionally, I am happy to share that automatic email notifications associated with tasks you've been assigned are now available in the platform.

Great eQMS for small and mid-sized businesses!

Nov 15, 2016
5/5
Overall

5 / 5
Ease of Use

4 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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Pros: Ease of use, responsiveness of development team

Cons: The software is feature rich, but there are still a few features that would be great to see implemented. The Greenlight team takes feedback to heart and is generally quick to implement requested features.

Overall: We've been using Greenlight.guru for the better part of a year now and it really simplifies quality management. It's very easy to get all of our team on the same page and effortlessly trace various efforts through the system. The Greenlight.guru team is one of the best I've ever worked with. They bend over backwards to help you reach your goals. They are fantastic partners.

Vendor Response

by Greenlight Guru on December 14, 2018

Hello Ryan, thank you very much for taking the time to review our software.

We're happy to hear you've enjoyed working with our team and our software has been able to help you simplify your quality management efforts.

Our team takes your feedback to heart and believes you'll be pleased with all the functionality we've released in 2017 and 2018 centered around post market surveillance, multi-level design controls, advanced document management, and flexible review and approval workflows.

Please keep the feedback coming regarding how we can further simplify quality management for your team.

New Quality System

Oct 09, 2018
5/5
Overall

5 / 5
Ease of Use

4 / 5
Features & Functionality

5 / 5
Customer Support
Likelihood to Recommend: 10.0/10 Not
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Pros: I love the ease of uploading documents and the automatic revision controls. Everything about the software is easy to understand and produces a digital trail for tractability.

Cons: I have not came across much of anything that I do not like about the software. If i ever have questions, I contact the customer service team and they walk me though it.

Vendor Response

by Greenlight Guru on October 12, 2018

Thank you, Valerie, for your feedback regarding Greenlight Guru. It's great to hear how the document management features are helpful to you and your team.

Transition in progress

Nov 15, 2016
5/5
Overall

3 / 5
Ease of Use

3 / 5
Features & Functionality

5 / 5
Customer Support

4 / 5
Value for Money
Likelihood to Recommend: 7.0/10 Not
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Pros: The relational database capabilities to link and trace. The CFR 11 and consistancy with 14971.

Cons: The structure is very rigid, which limits the ability to take advantage of some things in 14971 (like P1xP2 risk assessment) and some simply practical elements of design and development (like running separate and independent use, design and process FMEAs within a project.

Overall: In general, this is a very good upgrade from the manual, Excel-based approach we had been using. The automation of trace ability is Huge!

1) As our matrices have grown, the interface slows to a crawl, slowing the flow of data input and evaluation.

2) The inability to separate use, design and process FMEAs, which may have different structures (including or excluding detectability $ having different "frequency" distributions), results in a missing the value of trace automation for the matricies that need to be handled manually.

3) The system doesn't have an efficient way to implement P1xP2 analysis of risk probability, and is harm-centric.

Recommendations to other buyers: Figure out gow to run large data sets faster over teh internet, or better yet, allow local operation with ports to Greenlight when internet and or time allows.

Vendor Response

by Greenlight Guru on December 14, 2018

Evan - Thank you for your honest feedback and being a great customer.

Automation of traceability is one of our customers favorite pieces of functionality.

Your feedback has been very important in the performance improvements we've made to assure the matrices perform well for customers such as yourself with larger amounts of data.

Additionally, we look forward to getting your feedback on future iterations of the risk matrix functionality.

Best in the Biz

Nov 15, 2016
4/5
Overall

3 / 5
Ease of Use

3 / 5
Features & Functionality

5 / 5
Customer Support

4 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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Pros: Streamlines the quality process

Cons: Still in its infancy and some features can be developed to make it seamless

Overall: Greenlight Guru is a software that is paving a new path through a paper industry. With that, there will be bumps in the road from a functionality perspective. However, regardless of the bumps in the road the features are incredible and are only getting better as the team designs and iterates the software.

Recommendations to other buyers: Add a CAPA feature and other features to make the upkeep of the QMS a br

Vendor Response

by Greenlight Guru on December 14, 2018

Hi Jordan, thank you very much for taking the time to review our software.

Awesome to hear you agree the software is only continuing to get better with every release.

Per your comment regarding a CAPA feature set and others, this functionality was released as part of our Grow feature set in November 2017, which also included audits, customer feedback/complaints, and non-conformance.

This sort of feedback is vitally important to us and is taken into consideration as we continue to execute on our roadmap.

Don't ever hesitate to share additional feedback or improvement ideas with us via chat, phone, email at customer.success@greenlight.guru

Thanks!

Great overall product

May 07, 2019
5/5
Overall

5 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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Pros: Ease of use and very intuitive interface. Navigating the platform is very easy and functions such as uploading documents and routing are very easy to use.

Cons: Minor litle issues that seem to have been fixed in recent releases.

Overall: We are new to the QMS world and this software has been very useful.

Vendor Response

by Greenlight Guru on June 04, 2019

Hey Kevin -

Thanks for sharing your positive remarks! Our team is pleased to hear that our software has been useful for you and your team as you enter the QMS world.

Please feel free to reach out to us whenever you come across any minor issues or have other feedback that you would like to relay to our team.

Great Software for a Small Company

Dec 08, 2016
4/5
Overall

4 / 5
Ease of Use

4 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 9.0/10 Not
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Comments: We are a small, early-stage medical device company that struggles with all the usual small, early-stage company issues: minimal headcount, limited budgets but the same regulatory requirements that apply to anyone else in the space. Like many other companies in our position, we were using free or cheap tools to keep track of our design controls since we simply could not afford the systems that were available for purchase.

Enter Greenlight Guru. The system they presented was not only more affordable than anything we had encountered previously, but, being completely web-based, also did not require us to have any expensive IT infrastructure in order to implement.

The system is relatively intuitive, well thought out, and easy to understand both by someone entering information and someone reviewing the final product. We have already had several audits where this system has allowed us to quickly show that our design controls meet the regulatory requirements, which would have been much more difficult with our old, primarily manual methods of maintaining our records.

I would definitely recommend Greenlight Guru to anyone who has to follow design control regulations. It has certainly had a significant positive impact for us.

Vendor Response

by Greenlight Guru on October 12, 2018

Appreciate the comments, Sven. Let us know how we can continue to be helpful.

More functionality preferred

Nov 15, 2016
3/5
Overall

4 / 5
Ease of Use

2 / 5
Features & Functionality

5 / 5
Customer Support

3 / 5
Value for Money
Likelihood to Recommend: 4.0/10 Not
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Pros: online

Cons: very limited functionality

Overall: Overall the software is easy to use, but there are a few functionality that we wish were there, specifically:

- parallel approvers

- ability to attach redlines as part of routing (and then ability to publish clean copy); now it forces you to review redlines offline (not great since it gets lost in people's email, etc.)

- ability to reassign who can publish the document (if person who routed it is out and doc control/quality should be able to publish for them).

- ability to turn on email notifications if you have something in your inbox

Recommendations to other buyers: would like to see upcoming planned changes to software (functionality wise)

Vendor Response

by Greenlight Guru on December 14, 2018

Hello, Dieu. Thank you for your feedback. We heard you, loud and clear.

As a result of your feedback, we've added parallel routing and the ability to include redlines and mark-ups to review and approval workflows.

Additionally, we've since enabled user level email notification preferences for you to better control the types of messages you'd like to receive via email.

A viable mvp but not really ready for commercial needs

Nov 24, 2016
2/5
Overall

1 / 5
Ease of Use

2 / 5
Features & Functionality

3 / 5
Customer Support

1 / 5
Value for Money

Pros: Feature to read across related user needs, di, do and testing is a good idea. Printed matrix document looks nice.

Cons: So much clicking to accomplish needed tasks; not all features work as needed or expected.

Overall: We have been using Greenlight Guru now for a few months and I note the following concerns:

1) There is no undo button - once editing in a screen if you accidentally change something there is no way to return to the original state - clicking the close button will save ANY change you make even incidental ones.

2) Loading time is ridiculous. Our software currently has fewer than 300 requirements total and loading can take a few minutes.

3) Traceability for risk doesn't yet work properly in terms of tracing right through to V & V

4) Workflow could be dramatically improved - so many clicks are required to create each requirement.

5) Sometimes you will create a requirement and it does not show up in your list until you refresh the whole list - which led to a couple of duplicate requirements being created and these then can't be deleted - only obsoleted.

6) Document signing order created huge headaches for us organizationally in efficiently getting documents routed and signed.

7) Users who were in the application at the time of document routing received no notification a document was waiting for them.

8) There should be a way to check all validation and verification test cases within a given protocol off at once. Individually checking them off as passed is a make-work exercise.

9) Search feature is totally brutal and sometimes will not find something as simple as the DI title (e.g. searching for DI-159 which exists does not necessarily return DI-159).

10) When switching between projects - window did not always update content - leading to editing the wrong requirements

11) No way to sort requirements except through tagging- no way to view a short list of requirements only with a given tag reliably since search function can't be relied on.

Recommendations to other buyers: Needs more work and up-versioning before it is actually ready for market.

Vendor Response

by Greenlight Guru on October 12, 2018

Hi, Megan. Thank you for your candid and detailed feedback.
We took your feedback seriously and made updates to the Greenlight Guru software to address many of the issues you mentioned.

Greenlight Guru is a Great Document and Project Management Suite!

Nov 01, 2018
5/5
Overall

5 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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Pros: Document management is very easy to use and provides for easy review. There are many updates to the software so the service is always improving.

Cons: There was an issue with sorting documents and using the find feature, but those have been rectified in recent updates.

Overall: We are a medical device company so project and document management are very important things. Greenlight understands that and is very easy to use!

Vendor Response

by Greenlight Guru on November 07, 2018

Hi, Kevin. Thank you for the feedback. And appreciate you noticing the product updates.

Greenlight Guru

Mar 11, 2019
5/5
Overall

4 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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Pros: The ability to organize all documentation and execute design reviews and risk management within one platform.

Cons: Navigation can be a bit difficult at times.

Overall: The ability to properly and effectively manage our quality system and eliminate all paper documents.

Great QMS Software

Nov 29, 2016
4/5
Overall

4 / 5
Ease of Use

4 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 9.0/10 Not
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Pros: Easy to use and learn, integrates the entire Quality Management System into one interface.

Cons: It was difficult to use on mobile devices and tablets. It's been a while since I tried accessing it from either of these types of devices and may have changed since, but it would be nice to be able to pull up documents on a phone every once in a while.

Overall: As a small company developing our first medical device, greenlight.guru was an incredibly helpful tool. The software doesn't just provide a means of storing and organizing documents, but also provides an interface for product development and project management that is very useful.

Furthermore, the greenlight.guru team is nearly always available through the chat feature. On the rare occasions that issues do arise with the software, I've been able to get in touch with their programmers and resolved the matter within minutes.

Vendor Response

by Greenlight Guru on October 12, 2018

Hi, Jason. Thank you for your feedback. Yes, accessing QMS information from Greenlight Guru on mobile devices and tablets is tricky. We are exploring how to do this as part of the product roadmap.

Wrong kind of software for our demand so far

Nov 30, 2016
1/5
Overall

4 / 5
Ease of Use

3 / 5
Features & Functionality
Likelihood to Recommend: 1.0/10 Not
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Comments: Three main deficits: First there is no strukture for the data we save in Greenlight like direktorys, subdirektorys, a kind of tree... Colours... The only method to find data in the large pool is the serch funktion. This is useless if you don´t know the right name of what you are looking for.

Second deficit: We were told that data exchange with other systems is not possible. If that is really true I would immediately stop this software, but keep cool, I am far away from beeig responible.

Third deficit: Though the speed of the operations improved, it is still not acceptable. Important to know would be if the internet-connection we have at invendo is sufficient and reliable.

Positive: I have no doubt that you are able to program every kind of user interface we need. And I am very happy that you are really interested in my opinion. Feel free to ask me specific Questions.

Regards, Till Hoffmann

Vendor Response

by Greenlight Guru on October 12, 2018

Hi, Till. Thank you for your candid and honest feedback. Since your comments, Greenlight Guru has made quite a few product updates.
Document management has been enhanced with additional data attributes and ability to search, filter, and sort information more easily.
We continue to work on data exchange and have had some conversations with your colleagues on this.
Speed and performance are constantly monitored and being updated to ensure you get the information you need as timely as possible.
Keep the feedback coming!

Great e-QMS software

Mar 11, 2019
4/5
Overall

4 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support
Likelihood to Recommend: 10.0/10 Not
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Pros: Makes documentation easier! Love how its always updated with the current standards.

Cons: The risk management system and the search feature have scope for improvement.

Overall: Very engaging and great timely response by the customer success team!

Vendor Response

by Greenlight Guru on March 18, 2019

Amrita -

Thank you for taking the time to share your positive feedback!

We are happy to hear that you are enjoying our advanced document management platform and its associated workflows that keep your QMS compliant with current industry standards.

We would love to hear your feedback about how we can improve out risk management and search feature. I plan to have someone from our Customer Success team reach out to further discuss how we can integrate your feedback into our ongoing advancement of the software.

Thanks again!

Easy to use online tool

Nov 15, 2016
5/5
Overall

4 / 5
Ease of Use

4 / 5
Features & Functionality

4 / 5
Customer Support

4 / 5
Value for Money
Likelihood to Recommend: 8.0/10 Not
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Pros: Easy to use and very good for design control

Cons: Adding multiple files in one tab is not convenient unless you used a zip file

Overall: Greenlight.guru is a very easy to use and reliable online tool. Changes are automatically posted and all the features are easy to find.

Recommendations to other buyers: Multiple files should be part for the view when using document routing

Vendor Response

by Greenlight Guru on December 05, 2016

Hi Abel, thank you for taking the time to write your review of our software.

We are happy to hear greenlight.guru has been easy to use and manage your design controls.

Per your comment regarding multiple files being part of the view when using the document routing features, we really value your feedback and are happy to let you know that this specific feature is on our roadmap.

We will be sure to let you know when it is released. Thanks again for your input.

Decent Doc control program that needs some improvement

Nov 15, 2016
3/5
Overall

4 / 5
Ease of Use

3 / 5
Features & Functionality

5 / 5
Customer Support

4 / 5
Value for Money
Likelihood to Recommend: 7.0/10 Not
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Pros: Software is great for document control and for Design review and design freezes. Risk management functionality holds a lot of promise. Customer service is great.

Cons: No training feature as yet and Risk management doesn't seem to work well for our style. Would like to see more flexibility on how that works. Document list doesn't load well in Chrome.

Overall: Greenlight is excellent when you're still a young company and are able to grow with Greenlight. Lately, we would like more functionality with GL as our company is growing and features like training, and better/more flexible risk management matrix are needed. Hope to see GL grow, because their customer service is A+ and their advice and consultancy calls are also really good.

Recommendations to other buyers: Keep growing. I'd suggest rolling out training asap, it is a much-needed feature that we would like to have associated with our doc control program.

Vendor Response

by Greenlight Guru on October 12, 2018

Hello, Laura. Thank you for the feedback. We have enjoyed working with you and your team. Did you know you can manage training activities in the software today?
Regarding risk management, Greenlight Guru aligns with ISO 14971. And knowing that this standard will be revised soon, expect some updates to Greenlight Guru risk management workflow to continue to be in alignment with 14971.

Allow effective team-based collaboration on project traceability

Dec 11, 2018
5/5
Overall

5 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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Pros: Promote engagement from the team through its intuitive user interface and timely notifications on action items.

Cons: Sometimes it takes a while to get the refreshed information.

Overall: Very impressed by the software platform. Highly recommend medtech companies leverage this software platform to improve overall productivity.

Capterra loader

Excellent experience with Greenlight Guru

Feb 01, 2019
5/5
Overall

4 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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Pros: I like that all the tools and functions needed to run a QMS are centralized in one place

Cons: I would like line item requirements approval in the future

Overall: Its an excellent tool with very good customer support.

Vendor Response

by Greenlight Guru on February 04, 2019

Hey Daniel,

Our team appreciates your positive feedback! We are continuously evolving the capabilities of our quality platform to further enhance the value add to medical device companies.

I plan to have a member of our customer success team reach out to you in order to further discuss the line item requirements approval functionality you mentioned.

Thank you again for your feedback.

Capterra loader

User Friendly, Modern QMS System

Dec 11, 2018
5/5
Overall

5 / 5
Ease of Use

4 / 5
Features & Functionality

5 / 5
Customer Support

4 / 5
Value for Money
Likelihood to Recommend: 9.0/10 Not
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Pros: It is very modern and user friendly. Unlike most QMS systems which seam stuck in the 90s, they user interface is up to date with modern websites and is so easy to use it requires barely any training.

Cons: The modules that are full fledged are wonderful. Modules like change management and training management need to be its own module and updated.

Overall: The design and development module is truly the reason we purchased Greenlight. It is extremely simple, allows for easy/agile development and review and integrates risk.

Vendor Response

by Greenlight Guru on February 12, 2019

Hey Victoria,

Our team greatly appreciates you taking the time to provide us with valuable feedback. We are happy to hear that your team has adopted GG with ease and that our design and development features have been very beneficial for your company.

We are continuously advancing our software's capabilities and encourage you to share any thoughts or ideas with our Customer Success team regarding change and training functionality.

Thank you again for your feedback!

Alpha-C

Oct 23, 2018
4/5
Overall

4 / 5
Ease of Use

3 / 5
Features & Functionality

4 / 5
Customer Support

4 / 5
Value for Money
Likelihood to Recommend: 9.0/10 Not
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Pros: Lack of clutter on pages, ease of use. No nonsense.

Cons: Cannot view files on signature pages, have to page back to main menu.

Overall: We uses the software for creating the DHF and for signing off on documents. For this purpose it is very good.

Vendor Response

by Greenlight Guru on November 01, 2018

Hi, Barry. Thank you for your feedback.

Regarding viewing files on signature page, our Customer Success team will reach out to you directly to learn more about this need.

Affordable, sensible solution for QMS

Nov 29, 2016
4/5
Overall

4 / 5
Ease of Use

4 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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Pros: Visibility to elements required for 13485 compliance

Cons: Browser quirkiness

Overall: Our tiny team of 10 purchased Greenlight Guru a little less than a year ago. The team at Greenlight provided training and support to see us through our adoption of the tool. Their guidance, knowledge and support has been instrumental in getting our team compliant with quality systems regulations. We feel our decision to to purchase Greenlight was a key factor in meeting our early quality milestones and will be instrumental in our success to launch.

Vendor Response

by Greenlight Guru on October 12, 2018

Hello, Linda. Thank you for the feedback. It's been great to partner with you and your company and to see your market success.

Capterra loader

Software that actually makes your life easier!

Dec 13, 2018
5/5
Overall

5 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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Pros: The team at Greenlight is extremely passionate and have been amazing at supporting us and answering questions in record time.

Cons: If you don't use the software for a month, you get locked out and have to ask to be activated again.

Overall: Great support, easy to use.

Outstanding Software and service

Dec 08, 2016
5/5
Overall

5 / 5
Ease of Use

5 / 5
Features & Functionality

4 / 5
Customer Support

4 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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Pros: Ease of use, good functions, literally digitalized the fundamental proceeds of engineering a great quality medical device, webinars, support.

Overall: The customer service representatives are instrumental in the development of our startup. There knowledge and experience tremendously helped build a great QMS and risk system for our company to follow. Greenlight.guru should be used for any medical device and for in many other industries.

Vendor Response

by Greenlight Guru on October 12, 2018

Appreciate the feedback, Marsalas.

Robust and technically just what you need, with the customer support that knows their stuff. Period.

Nov 15, 2016
5/5
Overall

5 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money

Comments: We started working with Greenlight Guru about a year ago, and the support that we've been able to have since then has been excellent. Having an agile technical solution for your Quality and Design History management needs is a must have as the regulatory guidances shift and move constantly. We were just starting out and really learning our way through the setup and implementation of these device company infrastructural elements, and the GG software was the perfect fit for us and we're confident that will have ample room to grow as we add additional products to our portfolio.

Vendor Response

by Greenlight Guru on December 05, 2016

Hi Spencer, thanks for your honest feedback and being a great customer.

Glad you've found our customer success team to be knowledgeable and helpful.

One of the best QMS right now

Dec 08, 2016
4/5
Overall

4 / 5
Ease of Use

4 / 5
Features & Functionality

5 / 5
Customer Support

4 / 5
Value for Money
Likelihood to Recommend: 9.0/10 Not
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Pros: Doc management

Cons: Organize the publish documents better

Overall: We use this system as a quality management system. Greenlight guru has really helped us as a team that is at different places collaborate easily. Design reviews can now be done virtually. Sign off prompts and doc alerts really help in getting documents published faster. If there was one thing lacking, I would say the ability to make folders and organize the publish documents better. Never the less we are managing that by using the search function and our own doc log.

Vendor Response

by Greenlight Guru on October 12, 2018

Thanks, Ashley. Based on your feedback, Greenlight Guru implemented several enhancements to document management work space to help with organization.

Been with it since the beginning

Nov 18, 2016
5/5
Overall

4 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money

Comments: I've been using Greenlight.guru since it launched, and it has done nothing but improve, improve, improve. It constantly continues to impress with its breadth of features and ease of use. It is still not absolutely perfect but the fact that improvements come out so quickly reassures me that the team is committed to creating a good product.

Vendor Response

by Greenlight Guru on December 05, 2016

Hi Evan - Thanks for the feedback. We've been really happy to have you as a customer since the early days and are glad to hear you've been able to recognize our commitment to continuos improvement. Your's, and the feedback from all our early customers, has been invaluable to our improvement and growth.

Streamlined Quality System

Dec 08, 2016
5/5
Overall

4 / 5
Ease of Use

5 / 5
Features & Functionality

4 / 5
Customer Support

4 / 5
Value for Money

Comments: I work as an R&D Engineer for a small start up company working on a medical device. Greenlight.guru has made the process of implementing a quality system very easy and simple. The biggest benefit I've found is the simplified organization that the service provides, namely keeping all documents in one place and not having to continually keep track of updating and compiling documents as progress is made. Great tool!

Vendor Response

by Greenlight Guru on October 12, 2018

Hi, Ryan. Thank you for your comments. So glad you find the Greenlight Guru document management workflows helpful. Will you let us know if you have further questions and comments?

Greenlight Guru

Dec 08, 2016
4/5
Overall

3 / 5
Ease of Use

4 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money

Comments: It works well at keeping our documents organized. The search is useful. I think the menus are a little slow and confusing though.

Vendor Response

by Greenlight Guru on December 17, 2018

Hi, Jacob.

Great feedback.

Since you shared your comments, Greenlight Guru has rolled out advanced search functionality in the platform to make finding your information even easier.

We value your insight and feedback. Don't hesitate to share additional details like this with us at customer.success@greenlight.guru going forward so that we can incorporate it into the product roadmap.

Excellent Customer Services

Nov 15, 2016
5/5
Overall

5 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money
Likelihood to Recommend: 10.0/10 Not
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Pros: Easy to follow, uploading effective immediately. Easy to make changes/track changes.

Overall: Customer Services are always of high quality. The team is extremely friendly, and always try their utmost best to resolve all queries successfully.

Vendor Response

by Greenlight Guru on December 05, 2016

Hello Nabeela, thank you very much for taking the time to review our software.

Your input, and the feedback we receive from all our customers is very important to us.

We're happy to hear you've had some good experiences with our customer services.

Great eQMS

Nov 29, 2016
4/5
Overall

4 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

3 / 5
Value for Money
Likelihood to Recommend: 9.0/10 Not
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Pros: Organized, easy to use, eliminates burden of using paper.

Cons: Sometime the UX is a bit confusing. Just takes time to get used to.

Overall: I've had a very positive experience with Greenlight. It has saved a lot of time and headache for our company and the support is exceptional.

Vendor Response

by Greenlight Guru on October 12, 2018

Hi, David. Thanks for the comments. We continue to evolve the UX to make it as intuitive as possible. Will you contact us if you still have questions about this?

Amazing System

Nov 15, 2016
5/5
Overall

5 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money

Comments: Greenlight.guru has provided a significant amount of value to our company. Being that we are a small startup with team members decentralized, having a cloud based solution for document management can save considerable time and keep people on the same page. In addition, the risk management and design control modules are very easy to use and facilitate understanding with individuals that may not be as familiar with these processes.

Vendor Response

by Greenlight Guru on December 05, 2016

Thank you for your review!

great SW for management of new product development docs

Feb 15, 2019
5/5
Overall

4 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support
Likelihood to Recommend: 9.0/10 Not
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Pros: cristal clear management of risk, inputs and qara requirements

Cons: you have to refresh sometimes your browser

Good first experience but some mod needed

Nov 29, 2016
3/5
Overall

4 / 5
Ease of Use

2 / 5
Features & Functionality

4 / 5
Customer Support

3 / 5
Value for Money
Likelihood to Recommend: 6.0/10 Not
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Pros: easy to use, covers most of the basics

Cons: lack of flexibility is managing content across multiple sub-contractors working on the project.

UI can be refreshed to an easier form based on mobile use today

Overall: A couple missing key features discussed with GLG and hope they will be incorporated to allow us to better use the tool with our external vendors. These relate to file permissions and to release flow. I think these would benefit many companies like ours that rely on external vendors for portions of the development.

Recommendations to other buyers: This is all preliminary feedback as we are just starting to use the software :) thanks !

Vendor Response

by Greenlight Guru on December 17, 2018

Hi, Danny: Great feedback. We recently deployed sharing features within advanced document management that allow you to share specific information with sub-contractors and external vendors.

Additionally, the new Partner Views functionality now allows to collaborate with partners in a manner that goes beyond document sharing and includes both workflows and tasks.

We appreciate your insights! Keep the feedback coming.

Greenlight.guru is amazing

Nov 15, 2016
5/5
Overall

4 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money

Comments: The staff at greenlight.guru are extremely knowledgable and helpful. They onboard you, teach you how to use the software, and help navigate the intricate, and complicated, world of QMS for medical devices

Vendor Response

by Greenlight Guru on December 05, 2016

Hi Niru, thank you very much for taking the time to review our software.

We're glad to hear you've had a good experience working with our team navigating the world of QMS for medical devices.

Green light guru makes the Medical device manufacturer life easier & helps to society save the trees

Nov 16, 2016
5/5
Overall

5 / 5
Ease of Use

4 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money

Comments: We are using it from 8 months i feel very happy to use this because , it reduce the lot of paper printing work and whatever frame work is there in the tool are defiantly helps get the ISO certificates easily .

Vendor Response

by Greenlight Guru on December 17, 2018

Hi Umesh, thank you for taking the time to write your review. Glad to hear greenlight.guru has been able to reduce your reliance on paper and helping you achieve ISO 13485 certification.

Keeps us on track with great customer support

Dec 08, 2016
4/5
Overall

5 / 5
Ease of Use

5 / 5
Features & Functionality

5 / 5
Customer Support

5 / 5
Value for Money

Comments: Working with greenlight has been great. They take care of each account individually with their personalized tutorials face-to-face. The software is very useful in organizing and having a chain of custody for our documents. As a start-up, it helps us in setting up SOPs and quality control.

Vendor Response

by Greenlight Guru on October 12, 2018

Thank you for the feedback, Nishi.