For products marketed in the U.S., submitting product labeling information according to the FDA's XML-based Structured Product Labeling (SPL) standard is a given. Conforming to this important FDA standard is made easy with Virtify Global Labeling-SPL Module.
Virtify SPL Module enables rapid, efficient creation of SPL submissions in a collaborative, web-based structured content management environment. It provides centralized SPL lifecycle management with integrated workflow, including content creation, review, approval, and bidirectional communication with FDA.
It's built on Virtify's Structured Content Management (SCM) framework —an open, extensible architecture that uses common infrastructure and business components to dramatically increase efficiency and flexibility.
Virtify SPL Module offers a unique set of advantages, including:
Automated XML output—Automatically converts content to the proper SPL XML format, saving time and effort.
Concurrent authoring—Manage content down to the fragment level by enabling multiple users to edit the same SPL submission simultaneously, anywhere in the world. Dramatically increase productivity and compliance by ensuring all stakeholders are using approved content. Powerful version control and revision history.
Integrated validation engine—Ensures compliance with FDA SPL Guidance.
R4 compliant, R5 ready—Includes R4-compliant product listing data, labels and templates. As R5 develops, Virtify's flexible architecture will enable you to implement this device labeling standard rapidly and easily.
Ease of use—Intuitive, form-like interface and label templates are easy to use and easy to learn.