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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 Docs-IQ?

Relying on paper documentation can result in increased space demands, greater risks, and unnecessary labor! It often serves as a catalyst for receiving 483s during FDA evaluations. To mitigate these issues, implementing an automated document control system is crucial for organizations. Tailored for industries with strict regulations, Docs-IQ functions as a web-based document management solution. By adopting the Docs-IQ platform, companies can ensure compliance with their standard operating procedures (SOPs), Good Manufacturing Practices (GMP), and an array of other regulatory guidelines. The pharmaceutical industry deals with countless documents on a daily basis, and in the absence of a solid system, it runs the risk of being inundated with paperwork. In today's fast-paced environment, the introduction of an efficient document management system has become vital. A single document usually goes through nine different phases before it is finally archived or destroyed. Managing the entire lifecycle of a document, from its inception to its eventual disposal, presents significant hurdles for organizations that still rely heavily on paper. Each stage in this lifecycle requires extensive documentation, along with significant time, effort, and resources, highlighting the necessity for a more effective method of document management. Consequently, refining these procedures can not only boost compliance rates but also significantly enhance overall operational efficiency. Furthermore, a well-implemented system can lead to faster decision-making and a more agile response to regulatory changes.

Media

Media

Integrations Supported

Integrations Supported

EPIQ QMS by Caliber

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

Standard Support
Web-Based Support

Training Options

Documentation Hub

Training Options

Documentation Hub
Online Training
On-Site Training

Company Facts

Organization Name

Virje

Company Location

United States

Company Website

www.virje.com

Company Facts

Organization Name

Caliber Technologies

Date Founded

2001

Company Location

India

Company Website

caliberuniversal.com/solutions/document-management-system/

Categories and Features

Quality Management

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

Categories and Features

Document Management

Not specified

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