About 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.

Pricing starting from:

US$20,000.00

  • Free Version
  • Free Trial
  • Subscription

Typical Customers

  • Freelancers
  • Small Businesses (2-50)
  • Mid-size Companies (51-500)
  • Large enterprises (500 and more)

Deployment

  • Cloud-based
  • On-premise

Markets

Australia, Canada, Ireland, New Zealand, South Africa and 2 others

Supported Languages

English

Pricing starting from:

US$20,000.00

  • Free Version
  • Free Trial
  • Subscription

Images

Greenlight Guru Software - Greenlight Guru design control
Greenlight Guru Software - Greenlight Guru document management
Greenlight Guru Software - Greenlight Guru quality events management
Greenlight Guru Software - Greenlight Guru risk management
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Greenlight Guru Software - Greenlight Guru design control
Greenlight Guru Software - Greenlight Guru document management
Greenlight Guru Software - Greenlight Guru quality events management
Greenlight Guru Software - Greenlight Guru risk management

Features

Total features of Greenlight Guru: 30

  • Access Controls/Permissions
  • Alerts/Escalation
  • Audit Management
  • Change Management Software
  • Complaint Management Software
  • Compliance Management
  • Corrective and Preventive Actions (CAPA)
  • Data Visualization Software
  • Defect Tracking
  • Document Coding & Control
  • Document Management Software
  • Document Review
  • Document Storage
  • Document Templates
  • ISO Standards Management
  • Incident Management Software
  • Inspection Management
  • Maintenance Management Software
  • Nonconformance Tracking
  • Quality Control
  • Real-Time Data
  • Risk Assessment
  • Risk Management Software
  • Root Cause Analysis
  • Supplier Management
  • Supplier Quality Control
  • Task Management Software
  • Third-Party Integrations
  • Training Management
  • Version Control

Alternatives

Qualio

4.6
#1 Alternative to Greenlight Guru
Achieve 100% FDA/ISO/GxP compliance. 5x faster Document Control, Training, CAPA, NCRs, Audits and more. 2x faster...

Arena PLM

4.4
#2 Alternative to Greenlight Guru
Arena PLM brings product and quality information together into a centralized, cloud-native platform, empowering...

TrackWise

4.0
#3 Alternative to Greenlight Guru
TrackWise quality management provides a centralized system for managing, tracking, and reporting issues and actions...

AssurX

4.6
#4 Alternative to Greenlight Guru
AssurX’s powerfully flexible enterprise quality management software unites and coordinates information, activities and...

Reviews

Overall rating

4.5 /5
(67)
Value for Money
4.4/5
Features
4.2/5
Ease of Use
4.3/5
Customer Support Software
4.7/5

Already have Greenlight Guru?

Software buyers need your help! Product reviews help the rest of us make great decisions.

Showing 5 reviews of 67
Sarah
Sarah
Overall rating
  • Industry: Hospital & Health Care
  • Company size: 2–10 Employees
  • Used Weekly for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

A god-send of a QMS

Reviewed on 2018-12-11

As a new medtech company with many different product and differing product regulations, we are...

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.

Vineet
Overall rating
  • Industry: Medical Devices
  • Company size: 11–50 Employees
  • Used Weekly for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 8.0 /10

Truly Turnkey, Great for new companies

Reviewed on 2020-01-06

Greenlight.Guru has allowed us to, from a very young, inexperienced stage, build from scratch an...

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.

Alternatives Considered

AssurX and Arena PLM

Reasons for Switching to Greenlight Guru

Ease of use, well integrated design/risk controls, and Customer Support
Dieu
Overall rating
  • Industry: Medical Devices
  • Company size: 11–50 Employees
  • Used Daily for 2+ years
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 4.0 /10

More functionality preferred

Reviewed on 2016-11-15

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

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.

Alex
Overall rating
  • Industry: Medical Devices
  • Company size: 2–10 Employees
  • Used Weekly for 1+ year
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Greenlight is the right choice for eQMS

Reviewed on 2024-08-14

We evaluated multiple eQMS platforms, we went with Greenlight due to functionality, ability to...

We evaluated multiple eQMS platforms, we went with Greenlight due to functionality, ability to scale as we grow, and the extensive / pre-existing documentation that we could leverage and tailor to our needs.

Pros

Building a maintaining a QMS system that is FDA compliant is far too complicated and expensive for an early stage startup. Greenlight gives you the tools and platform to follow a pre-determined process that allows you to get up and running quick, while also having the confidence that you are meeting required regulations. Team has always been super helpful with great customer support.

Cons

eQMS can be complicated with lots of jargon. It does take a sustained push to become aquatinted with terminology and incorporate into you daily workflows.

Alternatives Considered

Qualio

Reasons for Switching to Greenlight Guru

We liked the team, the customer support, and the greenlight academy. We felt that greenlight had the tools to get us through a complicated process.
Mel
Overall rating
  • Industry: Medical Devices
  • Company size: 11–50 Employees
  • Used Daily for 6-12 months
  • Review Source

Overall rating

  • Value for Money
  • Ease of Use
  • Customer Support Software
  • Likelihood to recommend 10.0 /10

Only eQMS geared towards medical devices

Reviewed on 2021-04-28

Great experience! Customer service is quick to respond and there is a help centre and greenlight...

Great experience! Customer service is quick to respond and there is a help centre and greenlight academy with tutorials for quick reference. The traceability between design controls and risk elements is in itself worth it.

Pros

Wow so many things - selecting/modifying roles/permissions, creating teams, personalizing profiles, tagging documents, grouping documents, adding/uploading w/ w/out a change order, creating/activating training events, tracking training events' progress/completion, automating/completing quality events (CAPAs, nonconformance, audits and customer feedback), adding/modifying/tracing design controls i.e., user needs, design inputs/design outputs, V & V and finally adding/modifying/tracing risk items and aligning them to the project. Customer service is quick to respond and Greenlight Guru is always taking suggestions for improvement, they have even implemented some.

Cons

Just some suggestions for better functionality - ability to edit tags, ability to edit training events once activated or in the case the documents assigned to a training event changes, more user friendly quality event workspace, ability to easily change between full and lite users and vice versa.

Alternatives Considered

Qualio

Reasons for Switching to Greenlight Guru

Better price, only eQMS geared towards medical devices i.e., standard requirements are already built into the system.
Showing 5 reviews of 67 Read all reviews

Greenlight Guru FAQs

Below are some frequently asked questions for Greenlight Guru.

Greenlight Guru offers the following pricing plans:

  • Starting from: US$20,000.00
  • Free Trial: Not Available

Contact Greenlight Guru for pricing details.

Greenlight Guru has the following typical customers:

Self Employed, 2–10, 11–50, 51–200, 201–500, 501–1,000, 1,001–5,000

Greenlight Guru supports the following languages:

English

Greenlight Guru supports the following devices:

Greenlight Guru integrates with the following applications:

Jira

Greenlight Guru offers the following support options:

Email/Help Desk, FAQs/Forum, Knowledge Base Software, Phone Support, 24/7 (Live rep), Chat

Related categories

See all software categories found for Greenlight Guru.