Average Ratings 12 Ratings
Average Ratings 0 Ratings
Description
Over 1,000 medical device manufacturers rely on Greenlight Guru, a quality management system purpose-built for medtech. The platform is designed around the regulatory environment your industry operates in, not generic enterprise frameworks. FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and 21 CFR Part 11 are aligned at the foundation, not configured later.
Implementation takes weeks, not quarters. With 80+ audit-tested templates and medtech-expert support, you avoid the lengthy validation project and launch faster.
Greenlight Guru uses AI-powered automation to eliminate manual administrative work while preserving the audit trail and documentation standards your compliance requires.
With 15 years in medical device quality systems, Greenlight Guru helps you pass audits, get to market faster, and sustain long-term success.
Description
ValGenesis's VLMS offers an extensive array of features aimed at enhancing conventional validation methods. The platform delivers a complete perspective of the validation lifecycle, equipped with a robust management system, and can seamlessly connect with current infrastructures. By utilizing paperless validation software, it automates workflows, embeds compliance protocols within these processes, and facilitates electronic signatures through swift routing and timely notifications. Users can access metrics, dashboards, and reports instantaneously, making it easier to meet audit and inspection requests with minimal strain. This not only streamlines operations but also ensures that standards are upheld, promoting consistency in requirements management, testing strategies, and risk assessment practices. Overall, VLMS is designed to optimize efficiency and reliability in validation activities.
API Access
Has API
No
API Access
Has API
No
Integrations
GitHub
No
Google Drive
No
Jira
No
Microsoft 365
No
Pricing Details
Modules:
Document Management
Change Management
Training Management
Supplier Management
Design Controls
Risk Management
Parts Management
Quality Events
Software Parts
Software Release Management
SBOM Management
Software Test Automations
Pricing is custom scoped.
Document Management
Change Management
Training Management
Supplier Management
Design Controls
Risk Management
Parts Management
Quality Events
Software Parts
Software Release Management
SBOM Management
Software Test Automations
Pricing is custom scoped.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Greenlight Guru
Founded
2013
Country
United States
Website
greenlight.guru
Vendor Details
Company Name
ValGenesis
Founded
2005
Country
United States
Website
www.valgenesis.com
Product Features
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
No
Document Control
Yes
Equipment Management
No
ISO Standards Management
Yes
Maintenance Management
No
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes
Product Features
Medical Lab
Audit Trail
No
Data Analysis Auditing
No
Data Security
No
EMR Interface
No
Fax Management
No
Lab Instrument Interface
No
Multi-Location Printing
No
Online Instrumentation
No
Physician Test Panels
No
Procedure-Based Billing
No
Sample Tracking
No