Structured Product Labeling / Physicians Labeling Rule

Structured Product Labeling

The Virtx Structured Product Labeling (SPL) product is a state-of-the-art web-based application that enables organizations to:

  • Facilitate regulatory compliance
  • Automate generation of XML
  • Enable collaborative authoring and reviewing environment

The Virtx SPL is built on Virtx, an open, extensible architecture that uses common underlying infrastructural and business components. Key elements of Virtx SPL 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
Virtify's Virtx SPL global labeling solution is designed for organizations to meet the SPL and PLR standards put forth by the U.S Food and Drug Administration (FDA). Companies can use Virtx SPL to author, publish, review, and save SPL-compliant labels. Conversion of legacy labels created using Microsoft® Word is built into the system.
 

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