Core Data Sheet

Core Data Sheet

The Virtx Core Data Sheet product is a state-of-the-art web-based application that enables organizations to:

  • Disseminate changes in safety information
  • Facilitate Regulatory compliance
  • Manage core safety and labeling changes

The Virtx CDS is built on Virtx, an open, extensible architecture that uses common underlying infrastructural and business components. Key elements of Virtx CDS include:

  • Web-based Interface with AJAX
  • Role Based Access Control
  • Integrated Reporting
  • Powerful search mechanisms
  • Life Cycle History and Audit Trails
  • Infrastructure Support for multiple databases and document management systems
  • Configured for 21 CFR Part 11 Compliance

The current processes for dissemination of information pertaining to updates to Core Safety information, are labor intensive, inconsistent, and rely upon the efforts and knowledge of individuals. The existing processes for dissemination of a change and tracking relies on manual processes including face to face meetings, e-mails and conference calls. This is highly inefficient and is prone to error resulting in business liability and risk. As the scale of operations grows, so grows the potential for reporting delays, errors, or loss of critical safety information. This, in turn, increases business liability and risk.

Virtify’s Core Data Sheet Product, Virtx CDS can play a key role in centralizing, streamlining, and organizing core safety and labeling information, and thereby, greatly reduce the chance for delays or errors. Additionally, it can remove the reliance on individuals to be the sole maintainers of safety information.

 

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