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Description

You can now access your personal Quality Management Expert through an online platform designed for your convenience. With ready-to-use templates that can be seamlessly integrated into your organization, you can ensure efficient operations. Our offerings include comprehensive Quality Management Systems and digital solutions tailored for ISO 13485 related to Medical Devices, as well as ISO 9001 for General Quality Management, providing a robust framework for your quality assurance needs. Take advantage of our services to elevate your quality management practices to new heights.

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.

API Access

Has API No 

API Access

Has API No 

Screenshots View All

Screenshots View All

Integrations

No details available.

Integrations

No details available.

Pricing Details

$235 per month
Free Trial No 
Free Version Yes 

Pricing Details

No price information available.
Free Trial No 
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 No 
Mac No 
Linux No 
Chromebook No 

Customer Support

Business Hours No 
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 No 

Types of Training

Training Docs Yes 
Webinars No 
Live Training (Online) No 
In Person No 

Vendor Details

Company Name

MyBlueLabel

Founded

2018

Country

Denmark

Website

www.mybluelabel.com

Vendor Details

Company Name

Virje

Country

United States

Website

www.virje.com

Product Features

CAPA

Audit Management No 
CAPA Planning Yes 
Change Management Yes 
Complaint Management No 
Incident Management Yes 
Nonconformance Tracking No 
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 Yes 
ISO Standards Management Yes 
Maintenance Management Yes 
Risk Management Yes 
Supplier Quality Control Yes 
Training Management Yes 

Product Features

Quality Management

Audit Management No 
Complaint Management Yes 
Compliance Management No 
Corrective and Preventive Actions (CAPA) Yes 
Defect Tracking No 
Document Control Yes 
Equipment Management Yes 
ISO Standards Management No 
Maintenance Management No 
Risk Management No 
Supplier Quality Control No 
Training Management No 

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