<img src="https://ws.zoominfo.com/pixel/OJkQgdjSvoid2NFoB5Qs" width="1" height="1" style="display: none;">

Essentials

STARTUP KIT

Essentials include: 

  • Design Controls (1 Project)
  • Risk Management
  • Advanced Document Management
  • Change Management
  • Supplier Management
  • Task Management

_________________________

EASILY ACCESS AND CONTROL DOCUMENTS.

  • Part 11 Compliant E-signatures
  • Flexible Review & Approval Workflows
  • Document Revision Control
  • Proper Access & Usage

DOCUMENT YOUR DESIGN CONTROLS WITH FULL TRACEABILITY.

  • Multi-level Design Controls
  • Intuitive & Automatic Traceability Matrix
  • Digital Design Reviews
  • Living DHF

GAIN NEW VISIBILITY AND MITIGATE RISK.

  • Aligns with ISO 14971:2019
  • Integrated & Accessible Platform-wide
  • Custom Risk Acceptability Matrix
  • Living Risk Management File

Plus

ALL-IN-ONE SOLUTION

Essentials package and: 

  • Design Controls (Unlimited Projects)
  • Training Management
  • CAPA Management
  • Audit Management
  • Nonconformance Management
  • Complaint Management
  • Analytics

_________________________

CREATE A CONNECTED QUALITY ECOSYSTEM.

  • Purpose-built controls for medical device companies
  • Comprehensive, end-to-end, wholly traceable system
  • Effectively manage and connect design controls, risk, and quality events

STREAMLINE TEAM ACTIVITIES.

  • Efficiently organize, assign, and track training activities
  • Enhanced collaboration & productivity
  • Increase visibility & control into processes and procedures

ACHIEVE COMPLIANCE AND STAY AUDIT READY.

  • FDA, ISO, MDSAP, & EU MDR Best Practices
  • Complete Part 11 compliant audit trails
  • Quickly & easily provide objective evidence
  • More accurate & up-to-date traceability throughout the system

Professional

INTELLIGENT SOLUTION

Plus package and: 

  • Product Management
  • Visualize
  • Intelligent Document Management powered by HaloSM

_________________________

BUILD AND MANAGE YOUR BOM
  • Define and manage custom items and BOM attributes
  • Complete collaborative engineering change management
  • Manage your product and component information with full traceability

VISUALIZE YOUR QMS

  • See and interact with items in a centralized view
  • Understand relationships between items in your QMS
  • Virtual linking between items (powered by machine learning and natural language processing)

ANALYZE & PREDICT IMPACT

  • Change and update recommendations powered by AI and machine learning
  • Streamline the change control process
  • Reduce risk in missing key elements of a change

DATA-DRIVEN

  • Eliminate human error in identifying relationships and building traceability
  • Increased visibility into quality performance
  • Efficiently collect and evaluate trending quality information

Guru Services

ENHANCE YOUR TEAM WITH AN EXTENSION OF OURS.

Our seasoned medical device Guru's will ensure that you have what you need for your QMS implementation to run smoothly, while also providing clarity around the regulatory process and best practices for managing quality throughout your device's lifecycle.

DEDICATED QUALITY & REGULATORY EXPERT

  • Training 
  • Quality Assurance
  • Regulatory Compliance 
  • Audit Support

QMS Templates

GET STARTED WITH THE RIGHT DOCUMENTATION.

These audit-tested procedures, work instructions, and form will streamline the implementation of your quality management system and save you time during implementation and audits.

 

AUDIT-TESTED TEMPLATES FOR YOUR QMS

  • Quality Manual
  • Management Review Template
  • Project and Risk Plans
  • Supplier Survey Forms
  • Quality Event Procedures and Templates

Still not sure which plan is right for your team? 

Give us a call. 

+1 (317) 960-4220
Customer Success

Greenlight Guru is more than just software. 

Our Customer Success team is here to do more than solve technical issues. At Greenlight Guru, we value fanatical support. That means our noteworthy Customer Success and Medical Device Guru teams on your side to ensure that you and your team are always supported and on track to achieve success. They are here to help your team implement, maintain, and extract full value from your QMS to further your business. Your outcomes shape our outcomes - when you succeed, so do we.

 

Phone, Video Meeting, and Email Support

ic-2

 

Help Documentation & Live Training

ic-3

 

Industry Knowledge & Support Access

ic-1

 

G2-Crowd

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

Frequently Asked Questions

Do I need to buy onboarding services?
Are there any overage fees? Or data limitations?
Will I have to pay for software upgrades?
How is the software deployed?
What type of support is available to users?
Still not sure how Greenlight Guru’s medical device QMS software can help your business? Talk with us.
+1 (317) 960-4220