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What is Virje?

Virje complies with the regulations outlined in 21 CFR Part 11, 21 CFR Part 820, and ISO 13485. If you find the intricacies of Part 11 software validation overwhelming, you can find assistance readily available at your fingertips, regardless of your location or the time. By reducing reliance on paper, minimizing expenses, and boosting efficiency through automation and cohesive teamwork, it proves to be an excellent choice for small to medium-sized businesses. Specifically tailored for quality management in the medical device sector, this system is designed to be flexible, allowing you to adapt it to your particular workflows without needing to compromise. Its configurable change order approvals can be adjusted based on employee roles and document categories, with timely alerts sent to responsible team members at each step of the change process. Users can designate material dispositions for individual documents, effortlessly access both current and archived versions, and quickly review the history of document modifications. Moreover, it tracks the locations of use and the distribution of physical copies while providing reminders for regular document assessments, ensuring that compliance and efficiency are prioritized. This all-encompassing strategy not only enhances quality management processes but also enables organizations to uphold high standards with ease, creating a culture of continuous improvement and accountability.

What is Q-Med Database?

The Q-Med Database is an excellent resource for small enterprises aiming to achieve ISO 13485 compliance. This comprehensive database facilitates the effective management of various aspects, including corrective and preventive actions, nonconformances, internal audit schedules and findings, safety improvements, supplier corrective actions, and ongoing improvement projects. In addition, it allows for the compilation and analysis of customer survey results, as well as documentation of Quality Management System (QMS) review meetings and their outcomes. Furthermore, it is compliant with CFR21 Part 11, ensuring regulatory adherence, and offers both cloud-based and locally installed options to suit different operational needs. With its user-friendly interface, the Q-Med Database empowers small businesses to streamline their compliance efforts and enhance overall quality management.

Media

Media

Integrations Supported

Integrations Supported

Sunday Business Systems

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

$1900.00/one-time
Licenses based on concurrent users
Free Trial Offered?

Supported Platforms

SaaS

Supported Platforms

SaaS
Windows
On-Prem

Customer Service / Support

Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub

Training Options

Documentation Hub
Webinars
Online Training

Company Facts

Organization Name

Virje

Company Location

United States

Company Website

www.virje.com

Company Facts

Organization Name

Sunday Business Systems

Date Founded

2004

Company Location

United States

Company Website

sundaybizsys.com/q-med-database/

Categories and Features

Quality Management

Complaint Management
Corrective and Preventive Actions (CAPA)
Document Control
Equipment Management

Categories and Features

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
ISO Standards Management
Risk Management
Supplier Quality Control

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