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Average Ratings 14 Ratings

Total
ease
features
design
support

Description

Designed specifically for pharmaceutical and other GxP-compliant organizations, this solution streamlines the digitization of production, quality, and compliance processes within manufacturing operations. Empower your data to guide decisions effectively. With real-time event monitoring, teams can swiftly respond to performance issues and tackle quality challenges as they arise. Equip operators with a user-friendly tool that enhances their ability to achieve accuracy on the first attempt. Navigating the complexities of manufacturing is challenging, especially with the added layer of GMP regulations. By providing your teams with the appropriate resources, you can address critical issues and unlock transformative advancements. Significantly cut down on the time and effort needed for batch reviews and approvals through a review-by-exception approach, eliminating the need for exhaustive reviews of complete batch records. Furthermore, automate tedious tasks such as data input and verification, managing paper records across the production floor, carrying out and double-checking calculations, and overseeing workflows, among others. This not only enhances efficiency but also allows teams to focus on more strategic initiatives.

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.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

GitHub No 
Google Drive No 
Jira No 
Microsoft 365 No 

Integrations

GitHub Yes 
Google Drive Yes 
Jira Yes 
Microsoft 365 Yes 

Pricing Details

No price information available.
Free Trial No 
Free Version 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.
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 No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours No 
Live Rep (24/7) No 
Online Support Yes 

Customer Support

Business Hours Yes 
Live Rep (24/7) Yes 
Online Support Yes 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) No 
In Person No 

Types of Training

Training Docs Yes 
Webinars Yes 
Live Training (Online) Yes 
In Person No 

Vendor Details

Company Name

BatchLine

Founded

2015

Country

Thailand

Website

batchline.com

Vendor Details

Company Name

Greenlight Guru

Founded

2013

Country

United States

Website

greenlight.guru

Product Features

Manufacturing Execution

Document Management No 
Forecasting No 
Quality Control No 
Quote Management No 
Resource Management No 
Supplier Management No 
Supply Chain Management No 
Traceability No 

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 

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