Qualcy QMS Reviews & Ratings

Qualcy QMS

5.0 out of 5 stars
Greenlight Guru Reviews & Ratings

Greenlight Guru

4.4 out of 5 stars

Ratings and Reviews 1 Rating

Total 5 out of 5 stars
ease 5 out of 5 stars
features 5 out of 5 stars
design 4 out of 5 stars
support 5 out of 5 stars

Ratings and Reviews 14 Ratings

Total 4.5 out of 5 stars
ease 4.5 out of 5 stars
features 4.5 out of 5 stars
design 4.5 out of 5 stars
support 4.5 out of 5 stars

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What is Qualcy QMS?

Qualcy Biomed's quality management system (QMS) software is tailored specifically for biomedical enterprises, such as those in biotechnology and pharmaceuticals, to effectively handle QMS documentation in line with FDA and ISO 13485 standards. It ensures adherence to 21 CFR Part 820 and incorporates essential features like electronic signatures, audit trails, and compliance with 21 CFR Part 11. Additionally, the software facilitates the management of document change control, complaint handling, audits, corrective and preventive actions (CAPA), non-conformance records, and training records, among other critical functions, ensuring a comprehensive solution for quality management. This robust platform ultimately supports organizations in maintaining high standards of compliance and operational efficiency in their quality processes.

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

Microsoft 365
AWS Backup
AWS Cloud9
Gmail
Microsoft Azure
Microsoft Outlook
SAP Analytics Cloud

Integrations Supported

Microsoft 365
GitHub
Google Drive
Jira

API Availability

API Availability

Pricing Information

$799 per month
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.

Supported Platforms

SaaS
Android
iPhone
iPad
Windows

Supported Platforms

SaaS

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

Company Facts

Organization Name

Qualcy Systems

Date Founded

2014

Company Location

United States

Company Website

www.qualcy.com

Company Facts

Organization Name

Greenlight Guru

Date Founded

2013

Company Location

United States

Company Website

greenlight.guru

Categories and Features

Calibration Management

Calibration Instructions
Calibration Schedules
Compliance Management
Due Date Tracking
Gage Management
Label Printing

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)
Document Control
ISO Standards Management
Risk Management
Supplier Quality Control
Training Management

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