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
A well-implemented Quality Management System (QMS) is essential for biotech firms to achieve regulatory compliance. It will also help them maintain product quality and safety. It will also help them manage risks effectively. It will drive operational efficiency. InstantGMP QMS was designed by quality and regulatory professionals for biotech companies. It is simple, affordable, and complete. It can be used by small-to mid-sized manufacturers in many different industries. This quality management software features guided workflows to reinforce adherence with government standards during the entire production process. It also has a variety of innovative features and specialized module. Maintain and improve the safety and quality of biotech products. Frameworks are provided for identifying, assessing and mitigating risk throughout the product's lifecycle to reduce the likelihood of quality incidents or product recalls.
API Access
Has API
No
API Access
Has API
No
Integrations
GitHub
Yes
Google Drive
Yes
Jira
Yes
Microsoft 365
Yes
Microsoft Edge
No
Microsoft Excel
No
Microsoft Office 2021
No
Microsoft Word
No
QuickBooks Online
No
Safari
No
Integrations
GitHub
No
Google Drive
No
Jira
No
Microsoft 365
No
Microsoft Edge
Yes
Microsoft Excel
Yes
Microsoft Office 2021
Yes
Microsoft Word
Yes
QuickBooks Online
Yes
Safari
Yes
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
Yes
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
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
No
Types of Training
Training Docs
Yes
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
InstantGMP
Country
United States
Website
instantgmp.com/products/instant-qms/
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