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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 Validfor?

Validfor is a powerful and secure digital validation solution that brings all aspects of the validation process into one cohesive, paperless system, designed specifically for industries with stringent regulations. This platform effectively simplifies validation responsibilities while ensuring compliance with essential standards such as GAMP 5, 21 CFR Part 11, and EU Annex 11. By supporting electronic records and sophisticated electronic signatures, Validfor delivers complete audit trails and tailored workflows for different roles, including Author, Reviewer, and Approver, all while ensuring comprehensive CSV compliance. It systematically organizes all documentation and records in a centralized repository, diligently monitoring every change to preserve data integrity and uphold Quality Assurance. Moreover, Validfor includes integrated modules for Change Management, Deviations, Testing, and Periodic Reviews, which aid in conducting seamless impact assessments, tracking Corrective and Preventive Actions (CAPA), managing Computer Software Assurance (CSA), and overseeing audit-ready lifecycles. This all-encompassing strategy not only boosts operational efficiency but also fortifies compliance throughout a wide range of validation activities, making it an indispensable tool for regulated industries. In this way, Validfor empowers organizations to navigate complex regulatory landscapes with confidence and precision.

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

Validfor

Date Founded

2024

Company Location

Estonia

Company Website

validfor.com

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

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