Average Ratings 0 Ratings
Average Ratings 1 Rating
Description
Ennov Quality Suite. A comprehensive QMS to increase efficiency and ensure compliance. Ennov Quality Suite Ennov Quality Suite combines the power of Ennov Doc and Ennov QMS with Ennov Report and Ennov Training to create an integrated quality management solution that improves operational efficiency and ensures compliance to industry standards like 21 CFR Part 11, GxP, and ISO. Ennov Quality offers a predefined inventory that includes quality documentation, processes, and workflows. These are based on industry standards and best practices. Ennov Quality customers can quickly get their system in production and begin to realize their return on investment. Ennov Quality, as all Ennov solutions, is easy to set up and requires no IT skills. A unified and intuitive content and information management platform that supports and enriches the entire Life Sciences product cycle. Our comprehensive QMS improves operational efficiency
Description
SimplerQMS is an expert-driven electronic Quality Management System (eQMS) purpose-built for Life Science organizations. Our eQMS is designed by professionals with deep industry experience and supports compliance with FDA, ISO, and GxP requirements through automated, audit-ready quality processes.
The platform centralizes and automates core quality workflows within a cloud-based, fully validated system. Customers benefit from reduced manual work, fewer errors, and consistently organized, inspection-ready records.
Unlike generic QMS tools, SimplerQMS comes pre-configured for Life Science needs, with built-in templates, workflows, and controls aligned with FDA 21 CFR Part 11, 210/211, 820, EU Annex 11, ISO 13485:2016, and other applicable standards.
Beyond software, customers gain a trusted partner backed by deep regulatory and quality expertise. This includes:
• Audit-proven insights
• Guidance from compliance specialists
• Continuous system validation
• User training
• 24/7 global support
• Smooth implementation and data migration
• Dedicated Customer Success Experts
With a mission to help Life Science companies manage quality and regulatory documentation efficiently, SimplerQMS supports organizations from early-stage growth to global scale to strengthen compliance, operational control, and quality culture.
API Access
Has API
Yes
API Access
Has API
Yes
Integrations
Microsoft 365
No
Microsoft Entra ID
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
$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
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
Yes
iPad App
Yes
Android App
Yes
Windows
Yes
Mac
Yes
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
Ennov
Founded
1999
Country
France
Website
www.ennov.com
Vendor Details
Company Name
SimplerQMS
Founded
2017
Country
Denmark
Website
www.simplerqms.com
Product Features
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
No
ISO Standards Management
Yes
Maintenance Management
No
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes
Product Features
Audit
Alerts / Notifications
Yes
Audit Planning
Yes
Compliance Management
Yes
Dashboard
Yes
Exceptions Management
No
Forms Management
Yes
Issue Management
Yes
Mobile Access
Yes
Multi-Year Planning
No
Risk Assessment
Yes
Workflow Management
Yes
CAPA
Audit Management
Yes
CAPA Planning
Yes
Change Management
Yes
Complaint Management
Yes
Incident Management
Yes
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
Yes
Root Cause Analysis
No
Training Management
Yes
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
No
Controls Testing
No
Environmental Compliance
No
FDA Compliance
Yes
HIPAA Compliance
Yes
ISO Compliance
Yes
Incident Management
No
OSHA Compliance
No
Risk Management
Yes
Sarbanes-Oxley Compliance
No
Surveys & Feedback
No
Version Control
Yes
Workflow / Process Automation
Yes
Document Control
Archiving & Retention
Yes
Automated Routing
Yes
Change Management
Yes
Compliance Management
Yes
Electronic Signature
Yes
Escalation Management
Yes
Periodic Review
Yes
Version Control
Yes
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
Yes
Maintenance Management
Yes
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes