Are there automated validation tools for ensuring the completeness and accuracy of drug documentation in DITA?

November 10, 2023
|By Bryan Tipper

Ensuring the completeness and accuracy of drug documentation in DITA is crucial for pharmaceutical organizations to maintain regulatory compliance and patient safety. Automated validation tools play a significant role in achieving this goal by systematically checking content for errors, inconsistencies, and compliance with industry standards.

Automated Validation Tools

Pharmaceutical organizations can leverage automated validation tools designed specifically for DITA XML to ensure the completeness and accuracy of drug documentation. These tools can perform various checks, including:

  • Structural Validation: Ensuring that the document structure adheres to DITA standards, such as the correct use of elements, attributes, and nesting.
  • Link Validation: Verifying the integrity of hyperlinks within drug documentation, ensuring that references to other topics or external resources are valid and up-to-date.
  • Content Consistency: Checking for consistent terminology, formatting, and style across drug documentation modules to maintain a cohesive and professional presentation.
  • Compliance Checks: Confirming that drug documentation complies with regulatory requirements, including drug labeling standards and safety information.

These automated tools can significantly reduce the manual effort required to validate drug documentation and help identify potential issues early in the content creation process.

Example:

Here’s an example of how automated validation tools can be applied to DITA drug documentation:


<topic id="drug_labeling" version="1.0">
  <title>Drug Labeling</title>
  <body>
    <p>...

    <warnings>
      <validation-error type="structural">Mismatched element nesting.</validation-error>
      <validation-error type="link">Broken hyperlink: <link href="section1.dita">Section 1</link></validation-error>
      <validation-warning type="content-consistency">Inconsistent terminology.</validation-warning>
      <validation-error type="compliance">Non-compliant safety information.</validation-error>
    </warnings>
  </body>
</topic>

In this example, a DITA topic titled “Drug Labeling” undergoes automated validation, resulting in a list of warnings and errors. These alerts provide detailed information about structural issues, broken links, content consistency, and compliance concerns within the drug documentation.