Average Ratings 10 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

anicomply is a dynamic Electronic Batch Record (EBR) system tailored for pharmaceutical manufacturers, contract development and manufacturing organizations (CDMOs/CMOs), active pharmaceutical ingredient (API) producers, and various other industries where quality is paramount. This platform digitizes traditional paper-based or hybrid batch processes into efficient, executable workflows, distinguishing itself with remarkable speed; a standard recipe can be converted from a standard operating procedure (SOP) into an active digital workflow in just a matter of hours, rather than taking weeks. By employing a declarative methodology, process owners can implement numerous workflow modifications with minimal reliance on developers, which significantly decreases the need for programming, reduces iteration cycles, and alleviates resource constraints. The system is designed with essential features such as an integrated audit trail, electronic signatures, version control, and a four-eyes review process to meet GxP compliance requirements inherently. As a web-based application, it operates seamlessly across various devices and offers both cloud and on-premises deployment options, while also integrating smoothly with ERP, MES, and SCADA systems. Additionally, anicomply generates structured process data that enhances review-by-exception, ensures traceability, facilitates analytics, and lays the groundwork for future artificial intelligence applications. This comprehensive functionality not only improves operational efficiency but also bolsters regulatory compliance in manufacturing processes.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

No images available

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

anic GmbH

Founded

1996

Country

Germany

Website

www.anic-gmbh.de

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

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