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BE AUDIT READY 

AT A MOMENTS

NOTICE

A connected quality ecosystem where every record of your QMS is organized, centralized, and traceable

 

See it in action →

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It's the leading QMS designed specifically for the medical device industry, enabling a new way to manage your quality program.
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Track and manage quality events and associated follow up tasks digitally.
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Capture usable quality metrics in real-time.
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Assure your team's documentation is audit ready in real time.
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Drive traceability throughout your quality, design, and risk processes.
   

 

 

  • 21 CFR Part 11 Compliant
  • Workflows aligned to FDA and ISO standards for medical device predefined processes
  • FDA 21 CFR Part 820
  • ISO 13485:2016
  • ISO 14971:2019
QE Automation
NEW

Automate your quality event workflows

Avoid the rework and excess documentation involved with each new quality event opened, by implementing custom CAPA, Nonconformance, Customer Feedback, or Audit workflows to automate the step-by-step process.

Increase your team’s efficiency when managing post-market quality events with custom-built, automated workflows while still working within the guardrails of Greenlight Guru.

The connected quality platform built

for medical device companies

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POST MARKET SURVEILLANCE
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Simplify Quality Processes 

Enable a culture of quality by managing quality events like CAPA, Customer Feedback, and Audits in Workspaces with 21 CFR Part 11 compliant review and approval workflows to collaborate with internal and external stakeholders

See how teams are streamlining quality processes → 

 

SUCCESS STORY: How SimplicityMD used Greenlight Guru to explain complex  processes  Read the Success Story

RISK MANAGEMENT
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MANAGE RISK WITH EASE

Easily incorporate ISO 14971:2019 compliant risk-based controls into your quality and design processes throughout both development and post-market surveillance stages.

See integrated Risk Management in action → 

TRACEABILITY
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DRIVE END TO END TRACEABILITY - FROM DESIGN CONTROLS TO POST MARKET SURVEILLANCE

Assure traceability throughout the product lifecycle by easily linking post market activities to Design Controls, Risks, and Documents 

See it in action → 

 

RELATED WEBINAR: FDA partners with Greenlight Guru: Case for Quality webinar  series  Listen to the Webinar

DOCUMENT MANAGEMENT
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EASILY ACCESS UP-TO-DATE DOCUMENTS

Speed up reviews and approvals by keeping your documents, records, and procedures organized, up-to-date and always accessible to the right people with robust sharing and role based security.

See Advanced Document Management in action → 

 

SIMPLIFY QUALITY IN A RAPIDLY CHANGING REGULATORY ENVIRONMENT WITH GREENLIGHT GURU

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G2 Crowd provides real-time and unbiased user reviews to help you objectively assess what software is best for your business.

Read All Reviews

August 7, 2017
“Fantastic Product and Even Better Team”
The GG team goes out of their way to help us meet our business objectives. They are knowledgeable in the regulatory and quality management space and are always trying to improve their software and user experience.
Ryan Shelton
Validated Reviewer
Verified Current User
November 21, 2021
“Finally...eQMS software I have confidence in”

An efficient and controlled way of managing our documentation is now much more straightforward. I am confident that we are compliant with using GG

Kelly W.
Validated Reviewer
Verified Current User
November 19, 2021
“An Intuitive, Supportive, and Forward-thinking E-QMS”

Greenlight Guru are ahead of the game in terms of incorporating workflows which lead to compliance to ISO 13485:2016 and 21 CFR Part 820 regulations. The Change Management and Document Control functionalities make it easy to control records and document approvals especially in a world that is moving away from the traditional 'in-office' setting to remote working

Jacob S.
Validated Reviewer
Verified Current User
November 18, 2021
“User friendly eQMS that comes with a great team”

The software is user-friendly and customizable enough to meet your needs if you already have an existing QMS set up. But honestly, the best part is the team we work with for our transition process. They make the difference in this being a good experience. Their friendliness and wealth of knowledge about the medical device industry made the process so easy

Cynthia
Validated Reviewer
Verified Current User
November 17, 2021
“From Paper to electronic in less than 6 months”

With Greenlight Guru, we have been able to solve training gaps, on-time completion of customer complaints and non-conformances, and change orders. Previously to Greenlight, we had complaints that sat uncompleted for over a year; now with GG we are able to close them in less than 30 days.

Stacy M.
Validated Reviewer
Verified Current User
November 10, 2021
“Documentation and Collaboration Made Easy”

Greenlight Guru is life-changing! The platforms for documentation and collaboration have made me and my team so much more efficient. It has turned the huge headache of regulatory compliance into a much more manageable task.

Courtney L.
Validated Reviewer
Verified Current User
December 23, 2021
“The best QMS software for Medical Device companies”

Fantastic support, complete documentation package which just needs minor adjustments to suit the company, intuitive navigation through the menu, and different QMS modules inside the software. 

Petra E
Validated Reviewer
Verified Current User

See how our software enables a culture of true quality and accelerates outcomes 

See the Demo