How are medical organizations using DITA for compliance documents (e.g., FDA submissions)?

November 10, 2023
|By Bryan Tipper

Medical organizations rely on DITA to streamline the creation and management of compliance documents, including those required for FDA submissions. Compliance documentation in the healthcare and pharmaceutical industries is extensive, highly regulated, and subject to frequent updates. DITA’s structured authoring approach offers several benefits in this context.

1. Structured Content: DITA allows medical organizations to create structured, modular content. For FDA submissions, this means that different sections of the submission, such as preclinical data, clinical trial results, and labeling information, can be authored as separate topics. These topics can be easily reused, updated, and assembled into various submissions, saving time and ensuring consistency.

2. Version Control and Review: DITA supports version control and facilitates collaborative review processes. It ensures that all changes and comments are tracked, helping organizations maintain accurate records of their FDA submissions. Version control is crucial for compliance documents that undergo multiple revisions and require audit trails.

Example:

Here’s a simplified DITA example illustrating how structured content can be used for FDA submission sections:

<!-- Example: DITA Structured Content for FDA Submission -->
<topic id="preclinical-data">
  <title>Preclinical Data</title>
  <body>
    <p>This section contains preclinical data required for the FDA submission.</p>
    <p>...</p>
  </body>

<topic id="clinical-trial-results">
  <title>Clinical Trial Results</title>
  <body>
    <p>Here, you can document the outcomes of clinical trials.</p>
    <p>...</p>
  </body>

DITA’s structured authoring and version control features ensure that compliance documents meet regulatory requirements and can be efficiently managed and updated for FDA submissions and beyond.