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 EMEA-standard PIM, and the FDA-standard SPL/PLR.

Global Change Management through XML-based Labeling-Processes

XML-based Labeling Processes

The new standards such as PIM (EMEA) or SPL/PLR (FDA) intend to simplify electronic data exchange between pharma companies making applications and the regulatory agencies. The present labeling procedure is changing from the ground up, affecting the creation of documents, e.g. patient information, Summaries of Product Characteristics (SmPCs), or Core Data Sheets (CDSs). Manufacturers of medicines and life sciences products are required to convert to the data format XML and structure their product data as text modules in accordance with the specified DTDs.

SCHEMA's XML content management system allows companies to work on the basis of modules and to link information. Users can implement the requirements of the new standards and exploit the advantages of media-independent data storage.

The designated hierarchical structure of the standards can be represented in SCHEMA ST4, as can the dependencies between documents. 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.