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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 Ennov Process?

The Ennov platform features its own sophisticated workflow engine that enhances functionality. Ennov Training, Ennov eTMF, and Ennov RIM all leverage these workflows, which empower organizations to manage the order of tasks and modifications to data while ensuring transparency across the entire entity. Functional administrators have the ability to set up workflows through an intuitive graphical interface. To maintain uniformity, coherence checks are automatically executed upon saving changes. Ennov guarantees the reliability and consistency of its workflows. Additionally, each workflow within the Ennov system includes a customizable form, which incorporates dynamic sections that simplify data entry by adjusting the visibility of fields based on previously entered values (for instance, the type of Incident). Users can input free text, choose options from picklists, and upload supplementary files as necessary. An electronic signature may be required to finalize certain steps within a workflow, adding an extra layer of validation. This comprehensive approach to workflow management ultimately streamlines processes and enhances productivity across the organization.

Media

Media

Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Company Facts

Organization Name

Virje

Company Location

United States

Company Website

www.virje.com

Company Facts

Organization Name

Ennov

Date Founded

1999

Company Location

France

Company Website

en.ennov.com/insider/platform/product-brief-process/

Categories and 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

Categories and Features

Business Process Management

Access Controls / Permissions
Alerts / Notifications
Business Process Automation
Business Rules Management
Collaboration
Process Change Tracking
Process Mapping
Process Modeling & Design
Visual Workflow Management

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