Structured Product Labeling (SPL) and Product Information Management (PIM) has been mandated for pharmaceutical labeling materials and XML standards are available for Clinical Study Reports. Medical device companies have begun to use the Darwin Information Typing Architecture (DITA), though often with specializations, to manage labeling content. However, there are a number of opportunities to structure content like submissions documents, and on the customer facing side, sales and marketing materials. Structured content beyond the label brings many benefits including faster time-to-market, greater compliance, increased consistency, reuse, and reduced cost of translation.

This session:

• Identifies structured content opportunities beyond the label
• Outlines the benefits and savings
• Outlines the steps for achieving structured content

Reusing content is critical in helping to ensure that content is consistent regardless of where it appears, but many technical communicators hesitate to reuse content because they write for several different audiences, with different needs. For example, you may need to accommodate physicians, patients, and the FDA, and you may also need to accommodate the marketing requirements for your product. However, you can accommodate differences and still reuse content effectively. It’s all in the planning. This presentation shows you how to plan for effective reuse by creating content models that support different information products and different audiences, and how to create reusable content to support those models.

You’ll learn:

• How to analyze content to determine valid differences
• How to create content models to determine the different places content will be used
• How to accommodate differences through structure
• How to create writing guidelines that everyone can follow, ensuring your content is both usable and reusable

Structured authoring can provide many of the benefits of XML-based authoring and publishing, with lower start-up and maintenance costs. For many organizations, structured authoring provides an achievable migration target in a longer-term migration to XML. For other organizations, structured authoring alone may be the optimum target for maximizing publishing efficiency.

Structured authoring can provide similar benefits to XML-based authoring, with potentially lower costs, less migration pain, and lower maintenance costs. Also, structured authoring allows organizations to use conventional tools and retain authoring flexibility (the ability to apply manual formatting when necessary, for example) that many organizations still require.

Structured authoring may be a goal or a milestone on the way to XML. In either case, structured authoring can provide improved consistency, quality, and control, while “future-proofing” your technical publishing.

This session will introduce structured authoring and will look at how structured authoring can be implemented using several popular authoring and publishing tools.

Quick turnaround within the context of regulated documentation environments may be considered an oxymoron.  Although stringent approval sequences are necessary and important to the life sciences, technology can help mitigate process drag caused by creation and review cycles by enabling storage and reuse of quality linguistic assets.

Reuse of linguistic assets, generally categorized under the moniker of translation memory, has been widely used in the translation and localization industry for 20 years.  However, this reuse has been largely targeted to reuse of translations, not the reuse of source materials.

Recent product offerings, conceptually derived from translation memory and known as authoring assistance now bring the benefits of reuse to creators of source material, but this has been greeted with some reticence by the authoring community. Questions arise such as, “Why should I use a phrase just because it has been already translated into 20 languages?”

With documentation often following the development process like the caboose at the end of a train, and translation stumbling along the tracks trying to catch up with the caboose, authoring assistance provides technical writers new opportunity to improve overall corporate performance and to ease pain felt by downstream stakeholders.  By leveraging previously created linguistic assets, they can cut turnaround times, improve consistency, and become instrumental in reducing costs.  Moreover, they can adapt more quickly to product changes thrust upon them at the last minute by their upstream colleagues.  In short, authoring assistance technology can help authoring resources become stars in their organization.

This session will detail the benefits of an authoring assistance product and will demonstrate actual usage of this technology.