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What Is Greenlight Guru?

QMS software for medical device companies.

The platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits, document control, training, design control and more.

Device makers across the globe are replacing their outdated paper-based and general purpose legacy quality management system.

Who Uses Greenlight Guru?

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

Greenlight Guru Software - Doc. Management Spotlight
Greenlight Guru Software - Design Control Spotlight
Greenlight Guru Software - Risk Management Spotlight
Greenlight Guru Software - Quality Events Spotlight

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Reviews of Greenlight Guru

Average score

Overall
4.5
Ease of Use
4.3
Customer Service
4.8
Features
4.2
Value for Money
4.4

Reviews by company size (employees)

  • <50
  • 51-200
  • 201-1,000
  • >1,001
Sarah
Sarah
President & Chief Operating Officer in US
Verified LinkedIn User
Hospital & Health Care, 2–10 Employees
Used the Software for: 1+ year
Reviewer Source

A god-send of a QMS

5.0 6 years ago

Comments: 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.

Greenlight Guru Response

5 years ago

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
COO in US
Medical Devices, 11–50 Employees
Used the Software for: 1+ year
Reviewer Source

Alternatives Considered:

Truly Turnkey, Great for new companies

4.0 4 years ago

Comments: 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.

Dieu
Quality Manager in US
Medical Devices, 11–50 Employees
Used the Software for: 2+ years
Reviewer Source

More functionality preferred

3.0 8 years ago

Comments: 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

Greenlight Guru Response

5 years ago

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.

Mel
QA in Canada
Medical Devices, 11–50 Employees
Used the Software for: 6-12 months
Reviewer Source

Alternatives Considered:

Only eQMS geared towards medical devices

5.0 3 years ago

Comments: 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.

Chris
Senior Manager of QA in US
Medical Devices, 501–1,000 Employees
Used the Software for: 1+ year
Reviewer Source

Alternatives Considered:

My GG Experience

4.0 4 years ago

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