Making the Business Case for Structured Content Management
Many organizations across industries are leaving traditional Word-based workflow systems to implement SCM systems from providers like Esko, RWS, and Generis to take advantage of content reuse. With an SCM system in place, changes are created, managed, reviewed, and approved as a single component (as DITA XML or JSON) in only ONE place, then referenced by all the related documents so that updates are propagated automatically.
SCM systems typically allow companies to create new content in the DITA or JSON format from a template using an SCA editing tool. However, most organizations have mountains of EXISTING content currently in Microsoft Word or other unstructured formats and it is simply not feasible to re-create those one at a time in the SCM.
Let's look at some business cases for structured content management in the life sciences and pharma markets:
Labeling and Artwork
In the following example, a single change to the Core Data Sheet could require months of updates to all the related Word documents. With an SCM system in place, changes are created, managed, reviewed, and approved as a single component (as DITA XML or JSON) in only ONE place, then referenced by all the related documents so that updates are propagated automatically.
There are efficiency gains by eliminating copy and paste and implementing reuse within clinical trials. Applying the practices of SCM in clinical trials' protocols and statistical analysis plans facilitates efficiencies and consistencies in downstream documentation and content delivery to various channels and products.
Structured Product Labeling (SPL)
Life sciences organizations that sell regulated products in the United States are required to submit files in a structured XML format called SPL. DCL provides services to convert Microsoft Word and Excel files to the SPL XML standard and submit those files to the FDA on behalf of manufacturers and distributors so that it may be posted on the Daily Med website.
ePI or ePIL
Instead of investing in a full-scale SCM system or component content management system to produce multi-channel outputs, some clients use DCL to convert Package Insert (PI) or Patient Information Leaflets (PIL) documents on demand. As new PI/PIL documents are created, DCL transforms the files to HTML or similar structured formats that are delivered to company websites and mobile applications as ePI or ePIL.
For example, DCL recently completed a project for an Industry Consortium in Europe to convert Microsoft Word PIL content in 5 languages from multiple pharmaceutical companies into a custom format for delivery to the Consortium’s mobile application.
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DCL’s solution harnesses technology in Natural Language Processing and Machine Learning to help enable solutions powered by Artificial Intelligence. With sophisticated automated processes, DCL optimizes content to collect information, streamline compliance, facilitate migration to new systems and databases, maximize reuse potential, and ready it for delivery to all outputs.