Marketing products in Europe? Meeting the EMA submission requirements under EU 726/2004 Article 57(b) is easy with Virtify European Labeling.
Virtify European Labeling is the only off-the-shelf product that improves and streamlines XML-based product information submissions in a collaborative, web-based structured content management environment. It provides centralized product information lifecycle management with integrated workflow, including content creation, review, approval, translations, and bidirectional communication with EMA.
It's built on Virtify's Structured Content Management (SCM) framework—an open, extensible architecture that uses common infrastructure and business components that allows users to operate at the element and fragment level to dramatically increase efficiency and flexibility.
Virtify European Labeling offers a unique set of advantages, including:
Parallel process support—Easily manages multiple, concurrent versions of a submission by eliminating the burden of reconciling and merging content across submissions throughout the lifecycle. Provides comprehensive life cycle history and audit trails.
Granular content control—Enjoy role-based content control and re-use at the document, element, fragment, and language level.
Inter- and intra- submission of content— Comprehensive content linking accelerates labeling operations by maximizing content reuse while simultaneously improving consistency, quality and minimizing translation costs
Concurrent authoring—Manage content down to the fragment level by enabling multiple users to edit the different parts of all PI documents simultaneously, anywhere in the world. Dramatically increase productivity and compliance by ensuring all stakeholders are using approved content. Also, streamlines the development of all key Product Information including SmPC, leaflets, etc
Integrated translation management—Provides translation tracking and status reporting for all 24 EU languages.
Comprehensive commenting—Comments are displayed in-line with the content for rapid processing, in context. A full history of comments and actions is always just a click away.
Multi-layer versioning—Provides version layers for individual fragments, as well as for overall submissions, eliminating the need to track fragment changes separately.
Event-driven smart versioning—Automatically generate submission versions at key process events or milestones, ensuring data integrity throughout the submission lifecycle.
Ease of use—Intuitive, form-like interface and label templates are easy to use and easy to learn.