User Reviews Overview

Feature Ratings

Ease-of-use

4.0 / 5

Value for Money

4.5 / 5

Customer Support

5.0 / 5

Functionality

4.0 / 5

Ratings Breakdown

5 stars

(37)

37

4 stars

(18)

18

3 stars

(4)

4

2 stars

(1)

1

1 stars

(1)

1

  • Pros

  • "Aesthetically pleasing as well as practical and easy to use. "

  • "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. "

  • "Ease of use, good functions, literally digitalized the fundamental proceeds of engineering a great quality medical device, webinars, support. "

  • 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."

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

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

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December 2018

Sarah from Omeza

Company Size: 2-10 employees

Industry: Hospital & Health Care

Time Used: Less than 2 years

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

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.

January 2020

Vineet from Genetesis

Company Size: 11-50 employees

Industry: Medical Devices

Time Used: Less than 2 years

Review Source: Capterra


Ease-of-use

4.0

Value for money

4.0

Customer support

5.0

Functionality

4.0

January 2020

Truly Turnkey, Great for new companies

Greenlight.Guru has allowed us to, from a very young, inexperienced stage, build from scratch an easy to use and comprehensive quality system that has passed external audit with ease. The customer support, user interface, and turnkey solution offered by Greenlight.Guru has exceptionally useful for us, and been the foundation for Quality Management at our company.

Pros

Using Greenlight.Guru, we were able to build a quality system from scratch quickly that met our needs without the headache of complicated set-up and configuration. This tool enabled us to go from nothing to passing our first audit with confidence and ease. Great tools to link design and risk with documents and approvals. The customer service was also great, and Greenlight helped build our knowledge of Medical Device Quality at the beginning of our company's life, allowing many of us to rise from inexperience to competence to near mastery of quality systems. Greenlight further offers an unparalleled user interface and intuitive tools that make using it a cinch for almost all employees at our company.

Cons

Understanding best practices can be a bit challenging and time consuming given that there is one standard offering for all customers and customization is intentionally not available. Being a new company, Greenlight has grown with us. Some features that would have been nice to have earlier were developed and pushed during our use of the software, though it is clear that the product is maturing to meet the needs of its customers without sacrificing the ease of use.

Reasons for Choosing Greenlight Guru

Ease of use, well integrated design/risk controls, and Customer Support

December 2016

Grant from Hansei Consulting LLC

Time Used: Free Trial

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

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

Dieu from Diassess

Company Size: 11-50 employees

Industry: Medical Devices

Time Used: More than 2 years

Review Source: Capterra


Ease-of-use

4.0

Value for money

3.0

Customer support

5.0

Functionality

2.0

November 2016

More functionality preferred

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

Pros

online

Cons

very limited functionality

Response from Greenlight Guru

Replied December 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.

November 2016

Douglas from CardioQuip

Company Size: 2-10 employees

Industry: Medical Devices

Time Used: Less than 2 years

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

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?

April 2019

Art from BioSurfaces, Inc.

Company Size: 2-10 employees

Industry: Medical Devices

Time Used: Less than 6 months

Review Source: Capterra


Ease-of-use

5.0

Functionality

5.0

April 2019

Initial Review

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

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.

Response from Greenlight Guru

Replied April 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!

May 2019

Dalene from Southern Medical

Company Size: 11-50 employees

Industry: Medical Devices

Time Used: Less than 2 years

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

May 2019

Focus on the work - not the admin!

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.

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.

Response from Greenlight Guru

Replied June 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.

August 2019

Kevin from Nanofiber Solutions

Company Size: 11-50 employees

Industry: Biotechnology

Time Used: More than 2 years

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

August 2019

GreenLight is the best product development software

Pros

GreenLight team members are very responsive to concerns. The software itself is essential for any small-medium company hoping to get through the product development process and receive FDA clearance/approval.

Cons

I wish there was a training module. Training currently uses up a good amount of our time.

May 2019

Kevin from Fluoresprobe Sciences

Company Size: 2-10 employees

Industry: Biotechnology

Time Used: Less than 12 months

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

May 2019

Great overall product

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

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.

Response from Greenlight Guru

Replied June 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.

November 2018

Kevin from Nanofiber Solutions

Company Size: 11-50 employees

Industry: Biotechnology

Time Used: More than 2 years

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

November 2018

Greenlight Guru is a Great Document and Project Management Suite!

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

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.

Response from Greenlight Guru

Replied November 2018

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

November 2018

Jason from Nanofiber Solutions. Inc.

Company Size: 2-10 employees

Industry: Medical Devices

Time Used: More than 2 years

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

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

Industry: Medical Devices

Time Used: Less than 12 months

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

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

Industry: Design

Time Used: Less than 2 years

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

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

Industry: Medical Devices

Time Used: More than 2 years

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

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

Tonia from Lucerno Dynamics

Company Size: 2-10 employees

Industry: Medical Devices

Time Used: Less than 12 months

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

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.

November 2016

Michael from GCMI

Company Size: 51-200 employees

Industry: Medical Devices

Time Used: Less than 2 years

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

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

Industry: Medical Devices

Time Used: Less than 12 months

Review Source: Capterra


Ease-of-use

4.0

Value for money

3.0

Customer support

4.0

Functionality

3.0

November 2016

Jeff Schwegman Review

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.

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

Response from Greenlight Guru

Replied December 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.

November 2016

Marion from Diabeloop

Company Size: 11-50 employees

Industry: Medical Devices

Time Used: Less than 12 months

Review Source: Capterra


Ease-of-use

4.0

Value for money

3.0

Customer support

5.0

Functionality

3.0

November 2016

Diabeloop_MChassouant feedback

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!

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...

Response from Greenlight Guru

Replied December 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.

November 2016

Lizzie from Phagenesis Limited

Company Size: 11-50 employees

Industry: Medical Devices

Time Used: Less than 12 months

Review Source: Capterra


Ease-of-use

4.0

Value for money

5.0

Customer support

5.0

Functionality

4.0

November 2016

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

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.

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.

Response from greenlight guru

Replied December 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.

November 2016

Ross from Nanofiber Solutions

Company Size: 2-10 employees

Industry: Medical Devices

Time Used: Less than 2 years

Review Source: Capterra


Ease-of-use

4.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

November 2016

Great solution for medical device companies

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.

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.

Response from Greenlight Guru

Replied December 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.

November 2016

Ryan from PhotoniCare

Company Size: 2-10 employees

Industry: Medical Devices

Time Used: Less than 12 months

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

4.0

November 2016

Great eQMS for small and mid-sized businesses!

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.

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.

Response from Greenlight Guru

Replied December 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.

October 2018

Valerie from Berman Bedding, Inc.

Company Size: 11-50 employees

Industry: Medical Devices

Time Used: Less than 2 years

Review Source: Capterra


Ease-of-use

5.0

Customer support

5.0

Functionality

4.0

October 2018

New Quality System

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.

Response from greenlight guru

Replied October 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.

November 2016

Evan from Windgap Medical

Company Size: 2-10 employees

Industry: Pharmaceuticals

Time Used: Less than 6 months

Review Source: Capterra


Ease-of-use

3.0

Value for money

4.0

Customer support

5.0

Functionality

3.0

November 2016

Transition in progress

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.

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.

Response from Greenlight Guru

Replied December 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.

November 2016

Jordan from Lineus Medical

Company Size: 2-10 employees

Industry: Medical Devices

Time Used: Less than 12 months

Review Source: Capterra


Ease-of-use

3.0

Value for money

4.0

Customer support

5.0

Functionality

3.0

November 2016

Best in the Biz

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.

Pros

Streamlines the quality process

Cons

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

Response from Greenlight Guru

Replied December 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!

December 2016

Sven from SonarMed, Inc.

Time Used: Free Trial

Review Source: Capterra


Ease-of-use

4.0

Value for money

5.0

Customer support

5.0

Functionality

4.0

December 2016

Great Software for a Small Company

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.

Response from greenlight guru

Replied October 2018

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

November 2016

Megan from Arterys Inc.

Company Size: 11-50 employees

Time Used: Less than 6 months

Review Source: Capterra


Ease-of-use

1.0

Value for money

1.0

Customer support

3.0

Functionality

2.0

November 2016

A viable mvp but not really ready for commercial needs

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.

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.

Response from greenlight guru

Replied October 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.

March 2019

Ward from Intent Solutions

Company Size: 2-10 employees

Industry: Medical Devices

Time Used: Less than 2 years

Review Source: Capterra


Ease-of-use

4.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

March 2019

Greenlight Guru

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

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.

November 2016

Jason from Nanofiber Solutions, Inc.

Time Used: Free Trial

Review Source: Capterra


Ease-of-use

4.0

Value for money

5.0

Customer support

5.0

Functionality

4.0

November 2016

Great QMS Software

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.

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.

Response from greenlight guru

Replied October 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.

November 2016

Till from invendo medical GmbH

Company Size: 11-50 employees

Industry: Medical Devices

Time Used: Less than 2 years

Review Source: Capterra


Ease-of-use

4.0

Functionality

3.0

November 2016

Wrong kind of software for our demand so far

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 dont 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

Response from greenlight guru

Replied October 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!

March 2019

Amrita from Intent Solutions, Inc.

Company Size: 2-10 employees

Industry: Medical Devices

Time Used: Less than 6 months

Review Source: Capterra


Ease-of-use

4.0

Customer support

5.0

Functionality

5.0

March 2019

Great e-QMS software

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

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.

Response from Greenlight Guru

Replied March 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!

November 2016

Abel from Myolyn

Company Size: 2-10 employees

Industry: Medical Devices

Time Used: Less than 6 months

Review Source: Capterra


Ease-of-use

4.0

Value for money

4.0

Customer support

4.0

Functionality

4.0

November 2016

Easy to use online tool

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

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

Response from greenlight guru

Replied December 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.

November 2016

Laura from Sandstone Diagnostics

Company Size: 11-50 employees

Industry: Medical Devices

Time Used: Less than 2 years

Review Source: Capterra


Ease-of-use

4.0

Value for money

4.0

Customer support

5.0

Functionality

3.0

November 2016

Decent Doc control program that needs some improvement

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.

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.

Response from greenlight guru

Replied October 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.

December 2018

Anonymous

Verified Reviewer

Company Size: 11-50 employees

Time Used: More than 2 years

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

December 2018

Allow effective team-based collaboration on project traceability

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

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.

February 2019

Daniel from Spark Biomedical LLC

Company Size: 2-10 employees

Industry: Medical Devices

Time Used: Less than 12 months

Review Source: Capterra


Ease-of-use

4.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

February 2019

Excellent experience with Greenlight Guru

Its an excellent tool with very good customer support.

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

Response from Greenlight Guru

Replied February 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.

December 2018

Victoria from BIOREP TECHNOLOGIES, INC.

Company Size: 11-50 employees

Industry: Medical Devices

Time Used: Less than 6 months

Review Source: Capterra


Ease-of-use

5.0

Value for money

4.0

Customer support

5.0

Functionality

4.0

December 2018

User Friendly, Modern QMS System

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.

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.

Response from Greenlight Guru

Replied February 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!

October 2018

Barry from Metronom Health Inc

Company Size: 11-50 employees

Industry: Medical Devices

Time Used: Less than 2 years

Review Source: Capterra


Ease-of-use

4.0

Value for money

4.0

Customer support

4.0

Functionality

3.0

October 2018

Alpha-C

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

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.

Response from Greenlight Guru

Replied November 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.

November 2016

Linda from BeneSol

Company Size: 2-10 employees

Industry: Medical Devices

Time Used: Less than 12 months

Review Source: Capterra


Ease-of-use

4.0

Value for money

5.0

Customer support

5.0

Functionality

4.0

November 2016

Affordable, sensible solution for QMS

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.

Pros

Visibility to elements required for 13485 compliance

Cons

Browser quirkiness

Response from greenlight guru

Replied October 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.

December 2019

Nikunj from Hill Rom Inc

Company Size: 501-1,000 employees

Industry: Medical Devices

Time Used: Less than 12 months

Review Source: Capterra


Ease-of-use

4.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

December 2019

Medical Device QMS Productivity

Medical Device QMS has been overall win win situation to use at work place. It helps implementing best ISO 14985 practices and audit preparations as well.

Pros

QMS software is very easy to use and get around with. It's very hard for QMS software to be friendly and this one is super friendly all the time. Software has some of the remarkable QMS solutions for the medical device industry.

Cons

QMS sometimes run slow on network and it has some sort of license limitations depending on your company's contract but it can be fixed.

December 2018

Werner from Vitls Inc

Company Size: 2-10 employees

Industry: Hospital & Health Care

Time Used: Less than 2 years

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

December 2018

Software that actually makes your life easier!

Great support, easy to use.

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.

December 2016

Marsalas from SweetBio

Company Size: 2-10 employees

Industry: Medical Devices

Time Used: Less than 12 months

Review Source: Capterra


Ease-of-use

5.0

Value for money

4.0

Customer support

4.0

Functionality

5.0

December 2016

Outstanding Software and service

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.

Pros

Ease of use, good functions, literally digitalized the fundamental proceeds of engineering a great quality medical device, webinars, support.

Response from greenlight guru

Replied October 2018

Appreciate the feedback, Marsalas.

November 2016

Spencer from Lineus Medical

Time Used: Free Trial

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

November 2016

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

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.

Response from greenlight guru

Replied December 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.

December 2016

Ashley from Neurolab

Company Size: 2-10 employees

Industry: Biotechnology

Time Used: Free Trial

Review Source: Capterra


Ease-of-use

4.0

Value for money

4.0

Customer support

5.0

Functionality

4.0

December 2016

One of the best QMS right now

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.

Pros

Doc management

Cons

Organize the publish documents better

Response from greenlight guru

Replied October 2018

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

November 2016

Evan from Long Island Technology Group

Time Used: Free Trial

Review Source: Capterra


Ease-of-use

4.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

November 2016

Been with it since the beginning

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.

Response from greenlight guru

Replied December 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.

December 2016

Ryan from Esculon

Time Used: Free Trial

Review Source: Capterra


Ease-of-use

4.0

Value for money

4.0

Customer support

4.0

Functionality

5.0

December 2016

Streamlined Quality System

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!

Response from greenlight guru

Replied October 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?

December 2016

Jacob from Myolyn

Time Used: Free Trial

Review Source: Capterra


Ease-of-use

3.0

Value for money

5.0

Customer support

5.0

Functionality

4.0

December 2016

Greenlight Guru

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

Response from Greenlight Guru

Replied December 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.

November 2016

Nabeela from Phagenesis Ltd

Time Used: Free Trial

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

November 2016

Excellent Customer Services

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

Pros

Easy to follow, uploading effective immediately. Easy to make changes/track changes.

Response from greenlight guru

Replied December 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.

November 2016

David from Sonavex, Inc.

Company Size: 2-10 employees

Industry: Medical Devices

Time Used: Less than 2 years

Review Source: Capterra


Ease-of-use

4.0

Value for money

3.0

Customer support

5.0

Functionality

5.0

November 2016

Great eQMS

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.

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.

Response from greenlight guru

Replied October 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?

November 2016

Rian from SMD Manufacturing

Time Used: Free Trial

Review Source: Capterra


Ease-of-use

5.0

Value for money

5.0

Customer support

5.0

Functionality

5.0

November 2016

Amazing System

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.

Response from greenlight guru

Replied December 2016

Thank you for your review!

February 2019

Gabriele from Alifax

Company Size: 51-200 employees

Industry: Medical Devices

Time Used: Less than 6 months

Review Source: Capterra


Ease-of-use

4.0

Customer support

5.0

Functionality

5.0

February 2019

great SW for management of new product development docs

Pros

cristal clear management of risk, inputs and qara requirements

Cons

you have to refresh sometimes your browser

November 2016

Danny from Otonexus

Company Size: 2-10 employees

Industry: Medical Devices

Time Used: Less than 6 months

Review Source: Capterra


Ease-of-use

4.0

Value for money

3.0

Customer support

4.0

Functionality

2.0

November 2016

Good first experience but some mod needed

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.

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

Response from Greenlight Guru

Replied December 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.

Displaying 1 - 50 of 59 reviews