The Future of Labeling - Pharmaceutical Executive


The Future of Labeling

Pharmaceutical Executive

Reuse and repurposing of content. This is achieved by splitting today's monolithic documents into multiple components or objects and storing them in a content management system. Components can exist in multiple documents without the errors incurred by copying and pasting content typically seen with today's word processing software. In addition, the same content can be published to multiple output formats, including such formats as PDF or HTML.

Collaborative authoring and lifecycle features. When documents are composed of multiple objects, multiple authors can work on the same document at the same time. Each author can check out a different object related to his or her area of expertise, viewing the content within the context of the larger document, which is typically the case with the SPL Package Insert. In addition, a document composed of multiple objects in an intelligent CMS allows the security to vary on an object-by-object basis, thus allowing experts to edit, review and/or approve their sections within the context of the complete document

SPL is in fact the best thing to happen to XML. Companies will gain efficiencies while improving quality—as long as the issue is approached as a business strategy and not merely as the implementation of new technical standards. The strategic approach should be rooted in solving business problems and viewed as an evolution, not a revolution, in both industry technologies and corporate mentalities. Organizations should use a case-by-case approach that reflects a flexible framework, not a rigid methodology.

Organizing the Project The blueprint begins by developing a strategic plan with a complete enterprise view built around the impact of the XML standards. The plan should include:

Document analysis that identifies sources of content, redundancies within the content, and common content structure.

Identification of common business processes, such as creation, management, and consumption.

Access requirements by role: contributor, consumer, partner, and so forth.

The enterprise architecture should support both business process integration and technology integration, such as authoring tools, a content management solution, and publishing. A platform and architecture should be selected that will enable the company to adapt to SPL, PIM, study tagging files, eCTD, or other related XML-based applications. This prevents organizations from ending up with disparate systems that cost additional time and money due to different administrators, staff coordinators, and training processes.

Phased implementation of the technology should begin through a tactical, functional approach, with implementation tailored to a company's current priorities, such as which types of documents to tackle first. Clear, incremental progress will allow for measurement and communication of success throughout the implementation.

The Bottom Line? FDA's SPL mandate is actually a boon to the pharmaceutical industry. Companies would probably not put forth the effort or expense to implement XML if they weren't required to. Since noncompliance is not an option, implementation of XML with a focus on SPL actually presents an opportunity to greatly enhance current business processes.

There are key steps in a blueprint for moving forward:

  • Develop a strategic enterprise-wide plan that encompasses XML standards.
  • Define business and technical requirements. Incorporate document analysis, common business processes and access requirements.
  • Design an integrated enterprise architecture that is adaptable to standards.
  • Phase implementation based on priorities.
  • Establish clearly defined metrics to measure progress and anticipated improvements.

With SPL, PIM, and other initiatives currently under consideration, pharmaceutical companies need to view XML as a core technology that will allow them to adapt to the global industry's evolving changes. Companies that focus on single point solutions will end up spending more resources than they would if they adopted a strategic enterprise approach.

Sarah Powell is director of product strategy and Greg Kalten is technical director for First Consulting Group. They can be reached at


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