Beginning with the complex approval procedure for pharmaceuticals, content and size of labeling documents in the pharma industry are strictly regulated. Even after introducing the product into the market, these documents need to be continuously updated and maintained.

For change notifications, audit histories, or archiving, legal regulations must be followed. At the same time it must be ensured that the declarations of the regulating authorities are adopted in all document types, such as patient information or labels. The format of the documents is regulated by the QRD templates. Further requirements for documentation creation result from the need for multiple languages or from the need to convert to XML-based document standards such as the FDA-standard SPL/PLR.

Global Change Management through system-based Labeling-Processes

Automating change notification, tracking global implementation as well as accelerate consistent document modifications through reuse are - besides the ever changing regulatory requirements - challenges in current Labeling processes. It’s essential to optimize the change workflow starting from the Core Data Sheet leading to every regional labeling document such as Summaries of Product Characteristics (SmPCs) as well as folding boxes.

SCHEMA's authoring system allows companies to work with Microsoft Word on the basis of text modules and to link related information. Users can implement the requirements of the new XML-based standards and exploit the advantages of media-independent data storage.

Associated with the modularization of information is the significant reduction in effort for data maintenance. Changes that occur after introducing the medicine into the market are easier to integrate into the master data, and need only to be made once in the system. All affected documents are automatically updated, ensuring, for example, that mandatory changes to the Core Data Sheet are incorporated into the documents intended for the health authorities. In addition, sophisticated features make it easier to track internal or legal changes.

For the translation of documents, filters for and integrations with translation management technologies are included by default. An ergonomic user interface, as well as powerful production generators and default interfaces with layout programs, assist editors in quickly creating reliable documents.

By intelligently managing the relationship between documents, it is possible to:

• Improve and monitor compliance with internal and statutory requirements
• Change information once and reuse in many documents
• Continue to use Microsoft Word as an editing tool
• Create and manage multilingual documents such as European CP labeling documents PIM more efficiently and cost-effectively

SCHEMA ST4, as an XML-based component content management system, is much more than a specialist XML editor for Labeling. It is a sophisticated system for linked information in widespread use in the life sciences industry, as well as in plant and machinery manufacturing. SCHEMA ST4 incorporates functionality for cross-media publishing. Another standard function is the processing of multilingual content and internal translation memories. SCHEMA ST4 also offers standard interfaces to translation memory systems such as Trados and Across.