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What is Nova-QMS?

Maintaining consistent product quality and effective quality management systems presents considerable obstacles in today's pharmaceutical manufacturing environment. Sectors subject to rigorous regulations, such as Pharmaceuticals, Biotechnology, and Life Sciences, are required to follow Good Manufacturing Practices (GMP) to meet legal requirements. However, simply meeting GMP standards is not sufficient; organizations must also demonstrate compliance through proper documentation. Utilizing paper-based forms, disconnected systems, or manual processes to manage, track, and document quality-related issues and their resolutions does not provide adequate solutions for creating cohesive and integrated quality management systems that meet industry expectations. As a result, it becomes imperative for organizations to adopt more sophisticated and automated solutions to bolster their quality assurance initiatives and facilitate smoother compliance processes, ultimately leading to improved operational efficiency and product safety.

What is Greenlight Guru?

Greenlight Guru serves more than 1,000 device manufacturers with a quality management system engineered specifically for medtech. Rather than forcing your workflow into a generic platform, the system is architected around regulatory reality. FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, EU MDR, and 21 CFR Part 11 compliance is aligned at the core, not added as an afterthought. Go live in weeks instead of quarters. You get 80+ pre-validated templates and medtech expert guidance, so you skip the separate validation project entirely. Greenlight Guru integrates AI automation to reduce manual work while maintaining the audit trail and documentation rigor your business demands. With 15 years specializing in medical device QMS, Greenlight Guru helps you pass inspections, accelerate time-to-market, and build lasting commercial success.

Media

Media

Integrations Supported

GitHub
Google Drive
Jira
Microsoft 365

Integrations Supported

GitHub
Google Drive
Jira
Microsoft 365

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided
Free Version
Free Trial Offered?

Pricing Information

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 Version
Free Trial Offered?

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Novatek International

Date Founded

1996

Company Location

Canada

Company Website

ntint.com/product/nova-qms/

Company Facts

Organization Name

Greenlight Guru

Date Founded

2013

Company Location

United States

Company Website

greenlight.guru

Categories and 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

Categories and 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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