Based on the regional initiatives driven by the FDA and the EMEA new standards called SPL (FDA) and PIM (EU) have been implemented to provide a common electronic format for the accurate and efficient management of drug specific labeling documents. The PLmanager has been implemented from the perspective of the Pharmaceutical organisations which are engaged in international drug development, approval and maintenance processes.
EXTEDO developed the PLmanager Suite as a standardised and open software solution, especially for the creation, review, translation, maintenance and submission of electronic labeling documents e.g. company core data sheets (CCDS), SPL and PIM files and more, to the support internal as well as an integrated translation and drug approval process with EMEA and the FDA. The PLmanager has especially been designed to be fully functional on elementary hard- and software requirements. EXTEDO’s standardised software solution PLmanager is a high-quality and functional product for the straight forward Product Labeling management process.
The PIM (DES) and SPL specifications are an international standard for creating and submitting electronic labeling documents across the entire life cycle of associated drug products. PIM (DES) and SPL specify the format and the structure of an electronic labeling document.
The benefits of the PLmanager include:
• Runs on various types of IT-infrastructures (standalone, groupware, DMS based)
• Full support of all DES versions from 2.2 up to the newest one
• Full support of SPL
• Different users with simultaneous access
• Integrated validation mechanism according to the DES and SPL
• Integrated annotation and translation management
• Provides the interface of external translation tools (like SDL/Trados)
• Accurate and efficient management of labeling templates
• Easy to learn and easy to use application to improve business processes
Once an electronic labeling document has been created, validated and submitted to any agency the product specific life cycle starts. Agency specific annotations can be imported and processed by the sponsor. Easy support and overview of open translation tasks can be maintained efficiently. Drug specific changes within the scope of the product can be managed in an accurate and very efficient manner.
The PLmanager has been designed as a client/server architecture allowing different users access to one labeling document simultaneously. Labeling files can be reviewed at different sites and imported on a central site via a corporate network. If wanted, PLmanager can easily be integrated into state of the art document management systems such as:
• CSC (formerly FCG) First Doc, First Point
• EMC Documentum Content Manager
• IBM Score
• Microsoft Sharepoint
• OpenText Livelink
• QUMAS DocCompliance
• and others