The Virtx Enterprise Content Compliance Software Suite

The Virtx Software Suite provides a secure, collaborative web-based environment for managing compliance and regulated content throughout the product continuum. The workflow design enables collaborative content authoring, reviewing, archiving, and re-use – virtually eliminating inconsistencies and redundancy enterprise-wide. The Virtx suite is pre-configured to comply with different global standards and regulatory mandates such as Clinical Trial Disclosure, eCTD, SPL/PLR, and other electronic submissions standards. Upstream functions, such as content authoring and reviewing, are tailored to meet electronic requirements and standards – while downstream functions such as assembly, publishing, delivery and archiving are automated to the greatest extent possible. Additional enterprise compliance services such as planning, reporting, tracking, and resource management provide greater visibility into internal milestones and regulatory commitments.

Regulatory eCompliance

• Virtx SPL – Labeling application that complies with US FDA SPL R4 and PLR formats
• Virtx eCTD – eCTD builder, viewer and publisher supporting ICH as well as regional standards
• Virtx CTDS – Clinical Trial Disclosure System for compliance automation and management
• The Virtx platform has the following applications to support upcoming standards:
• Virtx PIM – Labeling supporting EU EMEA Product Information Management standards
• Virtx RPS – Product supporting HL7 (Health Level 7) Regulated Product Submission standards
• Virtx eStability – Product supporting HL7 Electronic Drug Stability standards

• Virtx SCM – Workflow enabled structured content management for collaborative document authoring, reviewing, assembly, publishing, and delivery
• Virtx CDS – Product for managing a company’s Core Data Sheet including change notifications and response tracking
• Virtx RIS – Regulatory Information Solution Platform combining process, methodology and a modular, componentized platform for organizational-specific regulatory operations information
• Virtx RMA – Web-based Resource Management and tracking
• Virtx ST – Submissions Tracking and planning
• Virtx IDM – Investigator clinical trials management
• Virtx PRS – Patient Registry/clinical trial management

The Virtx easy-to-use interface promotes adoption through advanced, Web 2.0 design and familiar desktop conventions. The open architecture of the suite is standards-based and is designed to leverage existing technology including security systems, databases, and legacy document management systems. The result is an integrated solution that enhances quality, performance, and compliance. 

All Virtx products are web-based and can be licensed separately (Software as a Service, perpetual), or in combination as part of an integrated Enterprise Content Compliance solution. The Virtx software suite is “compliant-ready” with current electronic submissions standards by ICH, HL7, CDISC, and other global standards organizations: