Average Ratings 0 Ratings
Average Ratings 11 Ratings
Description
It is difficult to make data available and actionable when a manufacturing site has many processes. As operations grow, it is becoming more difficult to comply with safety, quality, and environmental regulations. Manufacturing is built on predictability and reliability. Manufacturing by nature is all in the execution of established processes. TenForce was built from the feedback of our clients to map the operational reality in a plant.
Description
qmsWrapper is a connected Quality Management System (eQMS) built for medical device startups and SMEs. It helps organizations move from paper forms, Word documents, and spreadsheets to a scalable, AI-enabled QMS that grows with their business through Foundation, Lifecycle, and Vigilance. Designed for ISO 13485, ISO 14971, FDA QMSR, FDA 21 CFR Part 11, and EU MDR, qmsWrapper connects documents, quality events, risk, training, CAPA, technical documentation, and traceability in one platform.
Best For:
- Medical device and SaMD companies implementing or modernizing an ISO 13485 QMS.
- Startups and SMEs that want to grow from controlled documents to connected quality workflows without replacing their QMS.
API Access
Has API
No
API Access
Has API
No
Pricing Details
$9000 per year
Free Trial
No
Free Version
No
Pricing Details
€3,499
Foundation starts at €3,499 per year with unlimited users. Lifecycle and Vigilance pricing is available on request. All editions are designed to grow with your quality management needs without requiring migration to a new platform.
Free Trial
Yes
Free Version
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
Yes
iPad App
Yes
Android App
Yes
Windows
No
Mac
No
Linux
No
Chromebook
No
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
Yes
Mac
Yes
Linux
Yes
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Customer Support
Business Hours
No
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
Yes
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
TenForce
Founded
2001
Country
Belgium
Website
www.tenforce.com
Vendor Details
Company Name
qmsWrapper
Country
Canada
Website
www.qmswrapper.com
Product Features
Audit
Alerts / Notifications
No
Audit Planning
No
Compliance Management
No
Dashboard
No
Exceptions Management
No
Forms Management
No
Issue Management
No
Mobile Access
No
Multi-Year Planning
No
Risk Assessment
No
Workflow Management
No
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
Yes
Training Management
Yes
Complaint Management
Case Management
No
Complaint Classification
No
Corrective Actions (CAPA)
No
Customer Complaint Tracking
No
Feedback Management
No
Forms Management
No
Issue Tracking
No
Quality Assurance Management
No
Routing
No
Self Service Portal
No
Social Media Monitoring
No
Survey Management
No
Contractor Management
Contractor Database
No
Insurance Tracking
No
License Tracking
No
Permit Tracking
No
Skills & Competencies
No
Task Management
No
Work Hour Tracking
No
Document Control
Archiving & Retention
No
Automated Routing
No
Change Management
Yes
Compliance Management
Yes
Electronic Signature
No
Escalation Management
No
Periodic Review
No
Version Control
No
EHS Management
Audit Management
Yes
Corrective / Preventive Actions
Yes
Environmental Management
Yes
Environmental Risk Assessment
No
Forms Management
No
Incident Management
Yes
Industrial Safety Management
Yes
Injury Reporting
No
Inspection Management
No
MSDS
No
OSHA Recordkeeping
No
Occupational Health Management
Yes
Safety Risk Assessment
Yes
Training Management
Yes
Waste Management
Yes
Environmental
Air Management
No
Auditing
No
Compliance Management
No
Document Management
No
Emissions Inventory
No
Hazardous Materials Control
No
Sustainability Management
No
Training Management
No
Waste Management
No
Water Management
No
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
No
Document Control
Yes
Equipment Management
No
ISO Standards Management
No
Maintenance Management
No
Risk Management
Yes
Supplier Quality Control
No
Training Management
No
Safety Management
Audit Management
Yes
Corrective / Preventive Actions
Yes
Incident Management
Yes
Injury Reporting
No
Inspection Management
No
OSHA Recordkeeping
No
Safety Risk Assessment
No
Training Management
No
Product Features
CAPA
Audit Management
Yes
CAPA Planning
Yes
Change Management
Yes
Complaint Management
Yes
Incident Management
No
Nonconformance Tracking
Yes
Quality Control
Yes
Risk Management
Yes
Root Cause Analysis
Yes
Training Management
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
No
ISO Standards Management
Yes
Maintenance Management
No
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes