About Greenlight Guru

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

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

Greenlight Grow features CAPA management that identifies and addresses the issues...


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Supported Operating System(s):

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

64 Reviews of Greenlight Guru

Average User Ratings

Overall

4.48 / 5 stars

Ease-of-use

4.5

Value for money

4.5

Customer support

5.0

Functionality

4.0

Ratings Snapshot

5 stars

(40)

40

4 stars

(18)

18

3 stars

(4)

4

2 stars

(1)

1

1 stars

(1)

1

Likelihood to Recommend

Not likely

Very likely

Showing 1 - 5 of 64 results

December 2018

Sarah from Omeza

Verified Reviewer

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

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.

March 2020

Chris from Candid

Company Size: 501-1,000 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

March 2020

My GG Experience

Pros

GG is hands-down the most user-friendly s/w I have ever worked with. The GG team has truly created simple easy-to-use workflows, while still offering complex functionality that conforms to the rigors of ISO 13485 standards. I love how you can link tasks, documents, investigations, and CAPAs. I personally love their DMS and Customer Feedback workflows. They're easy on the eyes, tell the whole story and allow for easy routing and approving to key stakeholders.

Cons

GG's data analytics aren't very helpful and often inaccurate. The data they're tracking is rudimentary and seems to an after thought by the design team. Additionally, there is no reporting functionality in their Customer Complaints workflow. For example, if you're attempting to run a trend report for common root causes related to certain events, the s/w doesn't allow it. Therefore, I have to track everything outside of GG, especially for trend reports. Trend reporting and tracking is critical in any regulated industry, so I'm not sure why GG didn't think of this

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