Virtx Electronic Submissions Platform

Virtify’s Solutions are based on its unique electronic submissions platform (the Virtx e-platform) built on ICH, HL7, CDISC and other international standards. The products built using this platform fall into two categories:

1. Standards Based Products – Products under this category provide capabilities to convert, assemble, process, manage, quality control and transmission of data compliant with the agency regulations and standards. e.g., eCTD, SPL/PLR, PIM, RPS, eStability, etc.
2. Enterprise Products – Products under this category provide capability to automate, streamline and/or complement existing regulate product submission business processes. These set of products help in portfolio planning, submission planning, submission tracking, resource allocation, document/content workflow (e.g., authoring to electronic transmission to the FDA), safety and Adverse Event (AE) notifications, etc.
3. Infrastructure Components – Infrastructure components allow standards based products and enterprise products integrate seamless with existing organization infrastructure. This infrastructure can include existing document management systems, security systems, CRM, ERP, databases and others.

The Virtx e-Platform is built using industry standard software development practices. It offers a well defined API that can be used by developers to customize and built applications. The developers can leverage and consume the services offered by the platform and/or extend it to meet their own requirements. Since the platform is standards based and leverages ISO, HL7, CDISC and other standards it insulates the developers from the changes to these standards and helps them focus on developing applications to meet their business needs. The platform also offers development tools that facilitate ease of development and maintenance of the applications. These development tools include:

• Form Wizard – provides WYSIWYG drag and drop capability to create rich Web 2.0/ AJAX user interfaces based on standards.
• Code Generator – provides capability to generate a data model and automate component and database level code generation.
• Business Rules Manager – provides capability to manage and inject business rules based on DTDs, Schemas and others.
• Report Designer – provides capability to generate reports in industry standard format.
• Stylesheet Designer – provides capability to design a stylesheet or apply stylesheet to render content to a specific format.
• Workflow Designer – provides capability to configure design and apply workflows.