Average Ratings 0 Ratings
Average Ratings 10 Ratings
Description
To expedite the introduction of new products while adhering to international regulations, companies must streamline and automate their processes for gathering, monitoring, analyzing information, and addressing related challenges. QUMAS EQMS, previously known as ProcessCompliance, is a cloud-based platform designed for Enterprise Quality and Process Management, offering extensive integrated solutions for regulatory, quality, and compliance management within a validated Quality Management System (QMS) framework. By leveraging QUMAS’s data-centric methodology, organizations can adeptly manage quality-related content and easily access and repurpose quality data, ensuring thorough visibility into the quality landscape. Furthermore, QUMAS features interactive quality dashboards that provide an overview of QMS performance across various business sectors and quality initiatives. Users can generate reports that are easily exportable, shareable via email, or scheduled for regular updates. This platform also facilitates secure, efficient, and compliant information exchange among QMS departments in the cloud, enhancing collaboration and operational efficiency. Ultimately, QUMAS empowers organizations to meet their quality objectives while navigating the complexities of regulatory compliance.
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
No price information available.
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
No
iPad App
No
Android App
No
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)
No
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
Dassault Systemes
Founded
1981
Country
France
Website
www.3ds.com/products-services/biovia/products/life-sciences-quality-and-compliance/qumas-eqms/
Vendor Details
Company Name
qmsWrapper
Country
Canada
Website
www.qmswrapper.com
Product Features
Quality Management
Audit Management
No
Complaint Management
No
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
No
Document Control
No
Equipment Management
No
ISO Standards Management
No
Maintenance Management
No
Risk Management
No
Supplier Quality Control
No
Training Management
Yes
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