Product Information Management (PIM) 

The PIM Challenge

The centralised registration procedure has allowed companies to submit one marketing authorisation application to the EMEA in order to sell a product in all EU countries.  While providing the benefit of avoiding country-specific submissions, the centralised procedure requires applicants to develop duplicate labeling content for various product forms, strengths, and packaging presentations.  In addition, these product information documents must be translated into 23 EU languages.  As a result, centralized procedures have introduced a lot of content redundancy that requires on-going maintenance.

The EMEA and industry representatives developed the PIM initiative to eliminate content redundancy and improve the efficiency of interactions between applicants and regulators.  Although the PIM initiative has resulted in an effective XML based standard for submitting labeling content, PIM is technically complex and places a burden on applicants to build PIM files.  The challenge is for companies to efficiently implement PIM submissions and build PIM submissions in a user-friendly, intuitive way.

The xmLabeling for PIM Solution

Glemser’s xmLabeling solution is a global, content management system that addresses all global labeling requirements.  In addition to specialized functionality to generate PIM files, xmLabeling provides a comprehensive set of document management functionality that allows companies to eliminate redundant content, improve global tracking and control of multiple, parallel submissions, ensure that core product changes are reflected in all applicable global labeling documents, and automate document review, approval, and distribution processes.

Skilled Glemser consultants can help you with any part of your PIM implementation project and can leverage best-practice configurations and implementation accelerators for all system development lifecycle (SDLC) deliverables.

Key xmLabeling Features

Key features of Glemser’s PIM solution include: 

  • Pre-configured with Glemser’s best practices for the management CRP, MRP and national registrations
  • Support for Core Data Sheets (CDSs) and related compliance management capabilities to ensure that changes made to CDSs are reflected globally in all related product information documents
  • Intuitive PIM Dashboard to manage all aspects of a PIM submission through a full lifecycle
  • Pre-configured, QRD-compliant templates for SPCs, package leaflets and immediate, blister and outer packaging text documents
  • Robust translation management capabilities with integration to SDL Teamworks™ for automated translation
  • Ability to manage PIM content in an agency-neutral format to improve content re-use, insulate documents from rapidly changing DES versions, and simplify training and support requirements
  • Enhanced version management functionality to support complex, parallel variation processes
  • Full lifecycle management capabilities for internal processes as well as interactions with regulators, including embedded XML commenting
  • Ability to manage all global product labeling documents in any country or format, such as MS Word and PDF
  • Expandable with an SPL module to support US-based submissions of SPL files to the FDA

Glemser Implementation Services

Glemser offers a complete set of implementation services for xmLabeling projects.  Our skilled consultants can leverage best- practice configurations and predefined implementation accelerators to help you with all aspects of your global labeling project including:

  • Project management
  • Requirements analysis and system design
  • System installation and configuration
  • Custom software development, if needed
  • Testing and validation
  • Data conversion and migration
  • User training and support
  • On-going system administration and maintenance