xmLabeling®

xmLabeling is an Out-of-the-Box Solution for Managing Global Labeling Content

Pharmaceutical companies spend a great deal of time managing product labeling documentation such as Package Inserts (PIs), Summary of Product Characteristics (SmPCs), and Core Data Sheets (CDSs). The same information is often duplicated in multiple documents for various product strengths, dosage forms and presentations resulting in a vast set of labeling documents that are difficult to manage and keep synchronized.

At the same time, the Food and Drug Administration (FDA) is implementing the Structured Product Labeling (SPL) standard in the US and the European Medicines Agency (EMEA) is applying the Product Information Management (PIM) standard in the EU to support the submission of electronic labeling content in XML format.

Glemser offers xmLabeling, a global labeling management solution to help companies handle the complexities of labeling data and processes and ensure compliance with new XML-based regulatory requirements. xmLabeling manages the entire set of global labeling requirements, including SPL, PIM, world-wide national registrations, and CDSs.

xmLabeling for SPL is a pre-configured version of xmLabeling that enables companies to meet SPL requirements using out-of-the-box functionality and best practice configurations.  xmLabeling for PIM will allow you to fully comply with the latest PIM standards without customizations or complex configurations.

xmLabeling enables regulated companies to:

  • Ensure compliance with PIM and SPL by generating agency-specific renditions for submission
  • Improve efficiency by reducing the time required to create, review, approve and manage product labeling documents
  • Reduce costs by re-using documentation components in multiple labeling documents and allowing changes to be made once and applied in all applicable documents
  • Increase productivity by replacing manual procedures with automated workflows and electronic approvals
  • Reduce risk by ensuring the correct, approved version of labeling content is always used
  • Reduce complexity by allowing the organization to manage a single set of labeling content while still meeting output requirements in multiple renditions such as XML, PDF, MS Word, and HTML
  • Leverage investment in a scalable architecture to support other structured content authoring initiatives