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Greenlight Guru

Greenlight Guru

Overview

What is Greenlight Guru?

Greenlight Guru is a quality management platform designed specifically for medical device companies.The platform is designed to help companies get safer products to market faster, simplify FDA and ISO regulatory compliance, and provide a single source of truth by connecting…

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Recent Reviews
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Awards

Products that are considered exceptional by their customers based on a variety of criteria win TrustRadius awards. Learn more about the types of TrustRadius awards to make the best purchase decision. More about TrustRadius Awards

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Pricing

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What is Greenlight Guru?

Greenlight Guru is a quality management platform designed specifically for medical device companies. The platform is designed to help companies get safer products to market faster, simplify FDA and ISO regulatory compliance, and provide a single source of truth by connecting…

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  • No setup fee

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  • Free Trial
  • Free/Freemium Version
  • Premium Consulting/Integration Services

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Product Details

What is Greenlight Guru?

Greenlight Guru is a quality management platform designed specifically for medical device companies.

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

The vendor invites device makers across the globe to replace outdated paper-based and general-purpose legacy quality systems with Greenlight Guru to push beyond baseline compliance and achieve True Quality. A personalized demo is available at http://www.greenlight.guru

Greenlight Guru Features

  • Supported: Design Controls
  • Supported: Risk Management
  • Supported: Audit Management
  • Supported: Document Control
  • Supported: Quality Processes (CAPA, Nonconformance, Customer Feedback)
  • Supported: Analytics & Reporting

Greenlight Guru Screenshots

Screenshot of Design Control Spotlight: 
Documenting and managing Design Control traceability has never been easier. Perform Digital Design Reviews through flexible workflows to demonstrate compliance.Screenshot of Document Management Spotlight: 
Speed up reviews and approval workflows by keeping your records and procedures organized, up-to-date, and always accessible to the right people with role-based security.Screenshot of Risk Management Spotlight: 
Integrate Risk Management into all of your quality processes in a system that directly aligns with ISO 14971:2016.Screenshot of Post-Market Quality Events Spotlight:
Streamline your Post-Market Quality Activities to maintain full closed-loop traceability within your QMS.

Greenlight Guru Video

Greenlight Guru Integrations

Greenlight Guru Competitors

Greenlight Guru Technical Details

Deployment TypesSoftware as a Service (SaaS), Cloud, or Web-Based
Operating SystemsUnspecified
Mobile ApplicationNo
Supported LanguagesEnglish
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Comparisons

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Reviews and Ratings

(18)

Attribute Ratings

Reviews

(1-10 of 10)
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Score 9 out of 10
Vetted Review
Verified User
Incentivized
Greenlight Guru definitely has the better/more easily understood UI. I've tried several other training systems and haven't bumped into any of the issues I've faced before, like my training being completed by another person or glitches within the system. Greenlight Guru is a program that doesn't take too long to learn to use and get used to using.
Score 8 out of 10
Vetted Review
Verified User
Incentivized
Greenlight is far superior in terms of Design Controls and Risk Management. It is more modern and easier to use. Greenlight is more expensive than GAS. The customization in GAS is nice and the ability to add custom impacts to any module has helped significantly with ensuring proper impact assessment when making changes. Greenlight Guru offers a task module that is very custom, but it relies too much on the human creation of tasks as opposed to more auto-generated tasks from Change Management or potential other uses like Supplier Management and Equipment Management. Given Greenlight has implemented so many positive changes in the last three years we have been using it, I am confident these will be addressed soon. The Design Control module made up for the flaws listed above.
Jason Troutner | TrustRadius Reviewer
Score 8 out of 10
Vetted Review
Verified User
Incentivized
Qualio did not appear to be as robust a solution as Greenlight Guru, and in particular, did not have as strong of design control and risk management capabilities for medical devices. MasterControl was too involved and expensive, and the extra benefits that MasterControl provides were not relevant to us as a startup.
Score 10 out of 10
Vetted Review
Verified User
Incentivized
Paradigm 3 Document Management Software is a less user-friendly version compared to Greenlight Guru. There is no change order process, and there are many "settings" required for one person to view, edit and print documents.

Ensur Document Management System is more user-friendly than Paradigm, but the change order process is not as streamlined.
Score 10 out of 10
Vetted Review
Verified User
Incentivized
If you are looking for a medical device specific eQMS that you do not need to customize, Greenlight Guru is for you. With most of the other eQMS solutions out there, they are not industry specific, so you have to customize it to meet your needs. They also have built in regulatory intelligence, as the standards change, they update their solution to meet the standards (think ISO 14971).
Score 9 out of 10
Vetted Review
Verified User
Incentivized
We evaluated all 3 companies at the same time when we were "shopping" for an electronic quality management system solution. We spoke with other users about their experiences and received extremely positive feedback from 2 current Greenlight Guru clients. The clients highlighted the fact that they used Greenlight Guru in their audits, even with the FDA, and it went well. Greenlight Guru had comparatively more in-depth resources for SOPs, forms, and Work Instructions. Additionally, they have already made a name for themselves as general educators on Regulatory/Quality matters, as they run one of the few podcasts for the industry that are available. On the contrary, we had a very poor experience with the salesperson from Qualio, and had the impression that all documents would need to be manually created (couldn't just be uploaded), and there was a significant amount of work required to implement. (Conversely, the GG users said that implementation was quick, and only took a few months to get it up and running in a compliant manner.) For QT9, a current user gave a very poor review, and emphasized that it was not customizable, alerts could not be turned off, and that design controls were not part of the program. Since we required design controls as part of our QMS, we eliminated this product from our consideration.
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