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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 MyCellHub?

Optimize the various processes related to batch records, sanitation, environmental monitoring, and inventory management. Leverage software designed specifically for Good Manufacturing Practice (GMP) to improve the production of advanced therapies. This solution acts as a cohesive platform to align your team towards achieving manufacturing excellence on the first attempt. Remove the disarray caused by fragmented documentation by employing a singular software system that streamlines data gathering, review, approval workflows, detailed reporting, and valuable analytics. Ensure your staff follows the appropriate protocols in a timely manner with interactive work instructions that guide them through every stage. Rest assured that this software adheres to 21 CFR part 11 and EU Vol 4 annex 11 regulations. Ease the process of information recording with features such as barcode scanning, embedded data integrity safeguards, and automated calculations. The system also possesses features for detecting out-of-spec conditions and ensuring comprehensive review and approval processes. Keep track of your samples during the testing phases seamlessly, while efficiently arranging sample plans and automating trend analysis. Furthermore, oversee tasks related to maintaining cleanroom protocols and track various production stages to guarantee optimal outcomes. This holistic strategy not only boosts operational efficiency but also cultivates a culture of responsibility and accuracy within the manufacturing environment, ultimately leading to better product quality and compliance.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS

Customer Service / Support

Web-Based Support

Customer Service / Support

Web-Based Support

Training Options

Documentation Hub

Training Options

Documentation Hub
Webinars
On-Site Training

Company Facts

Organization Name

Virje

Company Location

United States

Company Website

www.virje.com

Company Facts

Organization Name

MyCellHub

Date Founded

2019

Company Location

Belgium

Company Website

www.mycellhub.com

Categories and Features

Quality Management

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

Categories and Features

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