Structured Product Labeling (SPL) 

The SPL Challenge

Life sciences companies spend a great deal of time managing global product labeling documentation, such as US Package Inserts (USPIs) and European Summaries of Product Characteristics (SPCs). 

In the United States, pharmaceutical, over-the-counter, biotech, and animal healthcare companies are required to submit product information documents, NDC labeler code requests, and establishment registrations to the FDA in an XML format called Structured Product Labeling (SPL).  In Europe, the EMEA has strongly recommended that by 2010 all centrally registered product information documents be submitted in an XML format called Product Information Management (PIM).  The SPL R4 and PIM standards are very different and continue to evolve at a very rapid rate.

Life sciences companies are faced with multiple global labeling requirements.  In the near term, they must comply with the SPL R4 standards in the US.   In the longer term, they must implement scaleable, flexible systems to ensure on-going compliance with evolving global XML standards.

The xmLabeling for SPL Solution

Glemser’s xmLabeling solution is a global, Documentum-based content management system that enables companies to generate SPL R4 files for submission to the FDA.

In addition to simply generating SPL 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 also help you with any part off your implementation project and can leverage best-practice configurations and implementation accelerators for all system development lifecycle (SDLC) deliverables.

Key xmLabeling for SPL Features

Key features of Glemser’s SPL solution include: 

  • Ability to create, edit, and manage content of labeling, drug listing, NDC labeler code requests and establishment registrations in SPL R4 format
  • Ability to import legacy SPL files into the content repository and automatically extract the drug listing information and convert the textual content from an SPL-specific to an agency-neutral format
  • Pre-configurations for US labeling document types in PLR (Physicians Labeling Rule) and non-PLR formats
  • Seamless integration with Quark’s XML Author or PTC’s Arbortext Epic XML editors to create labeling content in XML and support other structured content authoring initiatives
  • Pre-configured with Glemser’s best practices for the management of US, EU, and core product labeling documents
  • Change control
  • Enhanced version control to track parallel edits and submissions of the same product information document
  • Full lifecycle management capabilities for internal processes as well as interactions with regulators
  • Ability to manage all global product labeling documents in any format such as MS Word and PDF
  • Expandable with additional xmLabeling for PIM module to support European centralized registration procedures in PIM format

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