SimplerQMS Reviews & Ratings

SimplerQMS

3.0 out of 5 stars
Greenlight Guru Reviews & Ratings

Greenlight Guru

4.4 out of 5 stars

Ratings and Reviews 2 Ratings

Total 3 out of 5 stars
ease 3 out of 5 stars
features 2.5 out of 5 stars
design 2.5 out of 5 stars
support 3.5 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 SimplerQMS?

SimplerQMS is a specialized electronic Quality Management System (eQMS) tailored specifically for organizations in the Life Sciences sector. Designed by industry experts, our eQMS ensures compliance with essential regulations such as FDA, ISO, and GxP by facilitating automated and audit-ready quality processes. The platform effectively centralizes and automates fundamental quality workflows within a fully validated, cloud-based system, allowing clients to minimize manual tasks, decrease errors, and maintain consistently organized records that are always inspection-ready. In contrast to standard QMS tools, SimplerQMS is pre-configured to meet the unique requirements of the Life Sciences industry, incorporating templates, workflows, and controls that align with FDA 21 CFR Part 11, 210/211, 820, EU Annex 11, ISO 13485:2016, and other relevant standards. Furthermore, clients benefit from a reliable partnership that provides extensive regulatory and quality knowledge, which includes access to audit-proven insights, advice from compliance experts, ongoing system validation, user training, round-the-clock global support, seamless implementation and data migration, along with dedicated Customer Success Experts. Our mission is to empower Life Science companies in efficiently managing quality and regulatory documentation, enabling organizations to thrive from initial growth stages to global operations while enhancing compliance, operational control, and fostering a robust quality culture. By leveraging our expertise, businesses can streamline their processes and ensure they meet the highest industry standards.

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
Microsoft Entra ID

Integrations Supported

Microsoft 365
GitHub
Google Drive
Jira

API Availability

Has API

API Availability

Pricing Information

$17,500 / year
We offer subscription-based pricing with everything you need – integrated QMS modules, full implementation and onboarding, validation, user training, cloud hosting, QMS templates, data migration, and ongoing support. No hidden costs.
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
Mac

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
Online Training

Training Options

Documentation Hub
Webinars
Online Training

Company Facts

Organization Name

SimplerQMS

Date Founded

2017

Company Location

Denmark

Company Website

www.simplerqms.com

Company Facts

Organization Name

Greenlight Guru

Date Founded

2013

Company Location

United States

Company Website

greenlight.guru

Categories and Features

Audit

Alerts / Notifications
Audit Planning
Compliance Management
Dashboard
Forms Management
Issue Management
Mobile Access
Risk Assessment
Workflow Management

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Training Management

Compliance

Archiving & Retention
Audit Management
FDA Compliance
HIPAA Compliance
ISO Compliance
Risk Management
Version Control
Workflow / Process Automation

Document Control

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control

ISO Compliance

Not specified

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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