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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…

Entry-level set up fee?

  • No setup fee

Offerings

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The vendor invites device makers across the globe to replace outdated paper-based and general-purpose legacy quality systems with Greenlight Guru to push beyond baseline compliance and achieve True Quality.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

(1-14 of 14)
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Score 9 out of 10
Vetted Review
Verified User
Incentivized
  • Helped keep track of who trained to what within the biotech company, true importance (especially useful for audits).
  • A great training system and repository for quality/non-quality system documents in one.
Score 10 out of 10
Vetted Review
Verified User
Incentivized
  • Greenlight Guru has freed up time and manpower to focus on improving the quality of our products rather than spending our energy on paperwork.
  • Greenlight Guru has enabled a more effective organization system for all records that are required to be kept.
Score 9 out of 10
Vetted Review
Verified User
Incentivized
  • We've updated/ maintained our QMS more in the year that we've had Greenlight than in the previous 5 years combined; the efficiency of making changes is very valuable
  • The cost per full user and lite-user is not trivial, and to really get the most of the functionality you need to be a full user
  • We expect to accelerate product development once we get through our first couple of development projects
Score 10 out of 10
Vetted Review
Verified User
Incentivized
  • Investors love our level of quality thanks to the impact of Greenlight Guru on our organization!
  • No questions asked, great ROI! We continue to be amazed at how easy it is to use and how we do not need to hire a full time Greenlight Guru Administrator.
  • Our software developers love the User Interface, and they are not easy to please!
Score 9 out of 10
Vetted Review
Verified User
Incentivized
  • Has helped us to structure our QMS remediation efforts such that it's aligned with Greenlight Guru's implementation
  • Efficient workflows means that tasks can be tracked, so quality events are closely monitored and quickly investigated
  • Central repository for DHF/product-related documents allows for less mistakes made when referencing the newest, most updated form of the document(s)
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