Greenlight Guru

Quality management software for medical device industry

4,5 /5 (64 reviews) Write a Review!

Greenlight Guru Overview

What is Greenlight Guru?

Greenlight Guru is a cloud-based quality management software (QMS) designed to help businesses in the medical device industry create, launch, and manage custom workflow templates to streamline operations across multiple departments and teams. The platform allows organizations to automate quality procedures by integrating compliance and risk management guidelines into design and development processes.

The Greenlight Go, a premarket solution includes design control functionality, which enables enterprises to map resources with components, view relationships between objects, create traceability matrix, and track progress to ensure timely completion of projects. It offers a host of features such as historical data, electronic signature capturing, risk management, corrective actions and preventive actions (CAPAs) monitoring, change management, and more.

The document management module in Greenlight Guru lets managers view and store documents in a centralized repository, provide role-based permissions to external and internal stakeholders, and add watermarks to ensure data security. Administrators can also view, assign, escalate, and track feedback and complaints and maintain version history to conduct external or internal audits and inspections using Greenlight Grow, the post-market QMS module.

Greenlight Guru Overview

Pricing

Starting from
N/A

Pricing options

Free Trial
Subscription
Value for money

Contact Greenlight Guru for pricing details.


Greenlight Guru Features

Devices
Business size
S M L
Markets
United States, Canada, Australia
Supported Languages
English

Media

Greenlight Guru design control
Greenlight Guru document management
Greenlight Guru quality events management
Greenlight Guru risk management
Greenlight Guru video Greenlight Guru screenshot: Greenlight Guru design control Greenlight Guru screenshot: Greenlight Guru document management Greenlight Guru screenshot: Greenlight Guru quality events management Greenlight Guru screenshot: Greenlight Guru risk management

Greenlight Guru Reviews

Greenlight Guru Reviews

Overall rating
4,5
/
5
Excellent
40

Very good
18

Average
4

Poor
1

Terrible
1

Value for Money
4,4
Features
4,2
Ease of Use
4,3
Customer Support
4,8
91% recommended this app
Sarah K.

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.


Vineet E.

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.


Dieu W.

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


Amelia H.

Makes Implementing a Medical Device eQMS Easy

I work for a small medical device startup, and we've used Greenlight Guru to set up our quality management system from day one. They've made complying with ISO and FDA standards for quality management straightforward, they keep adding helpful functionality to the system, and I look forward to continuing to work with them!


Chris T.

My GG Experience


Sarah K.
Industry: Hospital & Health Care
Company size: 2-10 Employees

A god-send of a QMS

Used Weekly for 1+ year
Reviewed on 2018/12/11
Review Source: Capterra

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

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.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 10.0/10

Vineet E.
Industry: Medical Devices
Company size: 11-50 Employees

Truly Turnkey, Great for new companies

Used Weekly for 1+ year
Reviewed on 2020/01/06
Review Source: Capterra

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.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 8.0/10

Dieu W.
Industry: Medical Devices
Company size: 11-50 Employees

More functionality preferred

Used Daily for 2+ years
Reviewed on 2016/11/15
Review Source: Capterra

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

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.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 4.0/10

Amelia H.
Industry: Medical Devices
Company size: 11-50 Employees

Makes Implementing a Medical Device eQMS Easy

Used Daily for 1+ year
Reviewed on 2020/08/25
Review Source: Capterra

I work for a small medical device startup, and we've used Greenlight Guru to set up our quality management system from day one. They've made complying with ISO and FDA standards for quality management straightforward, they keep adding helpful functionality to the system, and I look forward to continuing to work with them!

Pros

Greenlight Guru has a very intuitive interface that lets me manage document changes and design control from the same dashboard. I can sit down and set up a change order to release and version multiple SOPs in an hour with a single set of approvals, which really streamlines my document control workflow.
It's also perfect for remote work, since it automatically captures electronic signatures and time stamps, and it's already set up to ping users by email when it's time for them to complete a task.
And I must commend their customer support team - they are an admirably responsive and helpful team of people who add so much value to the experience with this company.

Cons

Inputting a large number of documents into the system at a time can be fairly tedious. Some kind of mass upload function would be helpful at some point. I would appreciate an integrated training workspace as well, potentially tied to the document approval process.

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 9.0/10

Chris T.
Industry: Medical Devices
Company size: 501-1 000 Employees

My GG Experience

Used Daily for 1+ year
Reviewed on 2020/03/11
Review Source: Capterra

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

Rating breakdown

Value for Money
Ease of Use
Customer Support

Likelihood to recommend: 10.0/10

User recommendation
9/10
Based on 64 user ratings
Compare user recommendation rating with alternatives
Compare with alternatives

Greenlight Guru Pricing

Greenlight Guru Pricing

Starting from
N/A
Free Trial
Subscription
Value for money

Contact Greenlight Guru for pricing details.

Contact Greenlight Guru for pricing details.

Value for Money
4,4/5
Based on 64 user ratings
Compare value for money rating with alternatives
Compare with alternatives

Greenlight Guru Features

Greenlight Guru Features

API
Activity Dashboard
Activity Tracking
Audit Trail
Auditing
Automatic Notifications
Billing & Invoicing
Compliance Management
Customizable Reporting
Data Import/Export
Document Management
Document Storage
Inventory Management
Inventory Tracking
Monitoring
Real Time Data
Real Time Reporting
Reporting & Statistics
Third Party Integration
Workflow Management
Features
4,2/5
Based on 64 user ratings
Compare features rating with alternatives
Compare with alternatives

Categories

Additional information for Greenlight Guru

Additional information for Greenlight Guru

Key features of Greenlight Guru

  • Action Item Tracking
  • Calibration Management
  • Change Management
  • Compliance Management
  • Customer Complaint Tracking
  • Defect Tracking
  • Escalation Management
  • Incident Management
  • Quality Control
  • Re-engineering
  • Risk Assessment
  • Supplier Quality Control
  • Task Management
  • Testing Management
  • Training Management

Greenlight Guru FAQs

Greenlight Guru FAQs

Below are some frequently asked questions for Greenlight Guru.

Q. What type of pricing plans does Greenlight Guru offer?

Greenlight Guru offers the following pricing plans:

Pricing model: Subscription

Free Trial: Not Available

Contact Greenlight Guru for pricing details.

Q. What are the main features of Greenlight Guru?

Greenlight Guru offers the following features:

  • Action Item Tracking
  • Calibration Management
  • Change Management
  • Compliance Management
  • Customer Complaint Tracking
  • Defect Tracking
  • Escalation Management
  • Incident Management
  • Quality Control
  • Re-engineering
  • Risk Assessment
  • Supplier Quality Control
  • Task Management
  • Testing Management
  • Training Management

Q. Who are the typical users of Greenlight Guru?

Greenlight Guru has the following typical customers:

Small Business, Large Enterprises, Mid Size Business

Q. What languages does Greenlight Guru support?

Greenlight Guru supports the following languages:

English

Q. What type of pricing plans does Greenlight Guru offer?

Greenlight Guru has the following pricing plans:

Subscription

Q. Does Greenlight Guru support mobile devices?

We do not have any information about what devices Greenlight Guru supports

Q. What other apps does Greenlight Guru integrate with?

Greenlight Guru integrates with the following applications:

Frazer, Jira

Q. What level of support does Greenlight Guru offer?

Greenlight Guru offers the following support options:

Phone Support, Online Support, FAQs, Knowledge Base