Are there strategies for efficiently updating shared content across multiple pharmaceutical documents and regulatory submissions?

November 10, 2023
|By Bryan Tipper

Efficiently updating shared content across multiple pharmaceutical documents and regulatory submissions is crucial for maintaining consistency and compliance. DITA (Darwin Information Typing Architecture) provides strategies to achieve this while streamlining the content management process.

Content Reuse

One of the key strategies in DITA is content reuse. Pharmaceutical organizations can create modular content components that are shared across multiple documents. For example, information about drug interactions or safety warnings can be authored as standalone DITA topics. When these topics need updates or revisions, changes made to the source topic automatically propagate to all documents that reference them. This ensures that the latest information is consistently reflected in all relevant documents, reducing the risk of discrepancies.

Conditional Processing

Conditional processing, as supported by DITA, allows organizations to efficiently manage variations in content. Different regulatory jurisdictions may require specific content or warnings. With conditional processing, content can be tagged with conditions corresponding to specific jurisdictions. During document generation, DITA-aware tools can apply these conditions to include or exclude content as needed, ensuring that documents are tailored to the respective regulatory requirements while maintaining a shared source.

Example:

Here’s an example of how DITA enables content reuse and conditional processing for pharmaceutical documents:


<topic id="drug_interactions">
  <title>Drug Interactions</title>
  <body>
    <p>Common drug interactions.</p>
    <ph conkeyref="us_regulation">Content for the US.</ph>
    <ph conkeyref="eu_regulation">Content for the EU.</ph>
  </body>

In this example, a DITA topic “Drug Interactions” includes conditional content based on regulatory jurisdictions (e.g., US and EU). When generating documents for different jurisdictions, only the relevant content will be included based on the specified conditions, ensuring compliance with regional regulations.