If you think all QMS solutions are the same, let me introduce you to greenlight.guru

Exclusively designed for medical device companies, greenlight.guru is better than paper, smarter than Excel and SharePoint, and easier than legacy commercial EQMS Solutions.



The greenlight.guru Platform

Designed for FDA 21 CFR Part 11 Compliance
Intuitive To Use
Private Cloud-Based
Secure
Fanatical Human Support
Scalable

Quality Management

Integrated Quality Processes
Real-Time Visibility
User Dashboard
Unlimited Projects & Users
Required FDA & ISO Documents
Dynamic Reporting
Metrics
e-Signatures
Unified Management Dashboard
Live Workflow Status
Export Data
Role Based Security

Design Control

FDA Best Practices
Automatically Link Design Artifacts
Design History Files (DHF)
Design Reviews
Revision Control
Traceability Matrix
Electronic Sign Offs
Controlled Sharing
Collaborative Workspace
V&V Testing
Manage Product Requirements
Complete Audit Trail
Analytics & Reporting
Email Notifications
Advanced Searching

Risk Management

Aligned with ISO 14971
Link Design Controls & Risk Management
Determine Harm
Link Risk-Benefit Analysis
Risk Level Charts
Identify Hazards
Estimate and Evaluate Risks
Automated Risk Evaluation
Living Risk Management File
Identify Hazardous Situations
Identify Risk Controls
Update Residual Risk

Document Management

Complete Audit Trails
Single Repository
Workflow Status
Change Control
Electronic Signatures
Revision Control
Instant Notifications
Controlled Viewing, Printing & Exporting
Automated Routing, Reviews, Escalations & Approvals
Multi-Dimensional Linking
Automatically Link Documents
Advanced Search
Bulk Uploads
Retire & Archive Documents
Categorize, Classify, & Tag

"Finally, QMS software that's both compliant and practical to use"

Get a Free Demo
HELPING SOME OF THE WORLD'S MOST INNOVATIVE MEDICAL DEVICE COMPANIES BRING SAFER PRODUCTS TO MARKET FASTER
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Resources For You

how_to_avoid_a_medtech_documents_records_scavenger_hunt

How To Avoid a Medtech Documents & Records Scavenger Hunt
View the Slideshare
ultimate_guide_to_design_controls

The Ultimate Guide to Design Controls for Medical Device Manufactures
Read the eBook
fda_510k_submission_tips

5 Tips to Help Your FDA 510(k) Submission (Checklist Included)
Read the Guide
View All Resources >