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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The vendor invites device makers across the globe to replace outdated paper-based and general-purpose legacy quality systems with Greenlight Guru to push beyond baseline compliance and achieve True Quality.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

(17)

Attribute Ratings

Reviews

(1-15 of 15)
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Score 9 out of 10
Vetted Review
Verified User
Incentivized
  • Change orders.
  • Analytics.
  • Flow charts for complaints.
  • Flow charts for NCR.
  • Documents could are hard to searched.
  • It does not let you embed documents phases.
  • Other departments can see superseded documents it should only allow the RA/QA department to see them.
Score 10 out of 10
Vetted Review
Verified User
Incentivized
  • Document management.
  • Design and development documentation.
  • Quality Event Management, like training, CAPAs, and complaint management.
  • It's a very general software, meant to appeal to many, instead of being customizable for each individual customer.
Score 10 out of 10
Vetted Review
Verified User
Incentivized
  • The new training module ROCKS
  • Love the Audit module--better for tracking internal audits!
  • The change order function is the best I have seen
  • Periodic review of documents is an industry standard that is missing
  • Would love a training matrix similar to the design matrix that links with procedures/work instructions
  • Ability to modify or add parameters in the analytics function for better trending metrics
  • Ability to modify or add to predetermined "lists" in CAPA, Audits, Nonconformance workspaces
Score 9 out of 10
Vetted Review
Verified User
Incentivized
  • Change Orders are efficient and controlled, easy to route, and have good visibility
  • Internal audits are well designed, and easy to use
  • DHF management
  • The search engine for locating documents can be improved
  • While the consistent format across CAPA, non-conformities, and internal audits has benefits, the format does not always work in all cases
  • Notifications and tasks can be overwhelming
Score 9 out of 10
Vetted Review
Verified User
Incentivized
  • Greenlight Guru is designed specifically for medical device companies. In that, the platform helps meet FDA and ISO regulatory requirements.
  • Greenlight makes document review and approval easy - navigating the system is intuitive.
  • The Greenlight Guru team appreciates unfiltered customer feedback. They do take the voice of the customer seriously and will work to implement feature requests.
  • Document editing must be accomplished by downloading and re-uploading.
  • While the software is generally intuitive, users do have to really use the software to become proficient and to take advantage of its capabilities.
Score 10 out of 10
Vetted Review
Verified User
Incentivized
  • Excellent, knowledgeable (industry and software) support
  • Continue to evolve as a company - add new features consistently
  • Listens to customer feedback
  • In line document editing (but I am told this is coming!)
  • Ability to integrate with other systems (they are working on this I believe!)
  • Lack of user license variety - only Full or Lite.
Score 9 out of 10
Vetted Review
Verified User
Incentivized
  • Customer Service
  • Work Flows
  • Educational Resources
  • Out-of-the-box SOPs/WIs
  • Cannot currently upload more than one document at a time.
  • Documents cannot be edited without downloading and re-uploading.
  • There are some known bugs with some of the software (like the dates not displaying as they are input).
  • Work flows are rigid and sometimes do not leave room to add additional information in an organized way.
Score 9 out of 10
Vetted Review
Verified User
Incentivized
  • Greenlight Guru's cloud-based platform provides a very easy-to-use interface for all employees to participate in QMS activities.
  • Greenlight Guru provides a superior technological solution to QMS management over a traditional paper-based system.
  • Greenlight Guru's team is constantly updating and improving the platform to meet our needs as a medical device manufacturer. Their new capabilities, including employee training management, have been very valuable.
  • Early on there were some bugs in the software, but Greenlight's team typically resolved the bugs quickly. Occasionally we still come across some bugs.
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