Average Ratings 3 Ratings

Total
ease
features
design
support

Average Ratings 0 Ratings

Total
ease
features
design
support

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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

Streamline the processes involved in batch records, cleaning, environmental oversight, and inventory control. Enhance the production of advanced therapies using software tailored for Good Manufacturing Practice (GMP). This tool serves as an effective means to unify your workforce towards achieving ‘right-first-time manufacturing’. Eliminate the chaos of scattered paperwork by utilizing a single software solution that facilitates data collection, review and approval workflows, comprehensive reporting, and insightful analytics. Guarantee that your team adheres to the proper protocols promptly with engaging work instructions that guide them through each step. Enjoy peace of mind knowing that the software complies with 21 CFR part 11 and EU Vol 4 annex 11. Simplify the logging of information with features like barcode scanning, integrated data integrity measures, and automatic calculations. The system also includes built-in mechanisms for identifying out-of-spec conditions and ensuring thorough review and approval. Stay informed about the status of your samples throughout the testing phases, while efficiently organizing sample plans and automating trend analysis. Additionally, manage tasks related to maintaining cleanroom standards and monitor various stages of the production process to ensure optimal results. This comprehensive approach not only enhances efficiency but also fosters an environment of accountability and precision in manufacturing.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

GitHub
Google Drive
Jira
Microsoft 365

Integrations

GitHub
Google Drive
Jira
Microsoft 365

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.
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

Greenlight Guru

Founded

2013

Country

United States

Website

greenlight.guru

Vendor Details

Company Name

MyCellHub

Founded

2019

Country

Belgium

Website

www.mycellhub.com

Product Features

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

Product Features

Manufacturing Execution

Document Management
Forecasting
Quality Control
Quote Management
Resource Management
Supplier Management
Supply Chain Management
Traceability

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