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Average Ratings 11 Ratings

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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 

Screenshots View All

Screenshots View All

Integrations

Enhesa Yes 
Jira No 

Integrations

Enhesa No 
Jira Yes 

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 

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