Average Ratings 0 Ratings
Average Ratings 10 Ratings
Description
Virje meets the standards set forth by 21 CFR Part 11, 21 CFR Part 820, and ISO 13485. If you're feeling daunted by the complexities of Part 11 software validation, rest assured that help is just a click away, no matter where you are or when you need it. By eliminating paperwork, cutting costs, and enhancing productivity through automation and unified collaboration, it becomes an ideal solution for small to medium-sized enterprises. Designed specifically for medical device quality management, this system is constructed to be adaptable to your unique workflows and processes, ensuring you don’t have to make any sacrifices. It features configurable change order approvals that can be tailored by employee role and document type, along with timely notifications sent to accountable team members throughout every phase of the change process. Users can assign material dispositions for specific documents, gain easy access to both released and archived versions, and quickly view the history of document changes. Additionally, it tracks where-used locations and the distribution of hard copies, while also providing reminders for periodic document reviews to ensure compliance and efficiency remain top priorities. This comprehensive approach not only streamlines quality management but also empowers organizations to maintain rigorous standards effortlessly.
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
API Access
Has API
Integrations
Jira
Pricing Details
No price information available.
Free Trial
Free Version
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
Free Version
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Deployment
Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Customer Support
Business Hours
Live Rep (24/7)
Online Support
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Types of Training
Training Docs
Webinars
Live Training (Online)
In Person
Vendor Details
Company Name
Virje
Country
United States
Website
www.virje.com
Vendor Details
Company Name
qmsWrapper
Country
Canada
Website
www.qmswrapper.com
Product Features
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
Product Features
CAPA
Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management
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