What is the role of version control and change tracking in drug documentation using DITA?

November 10, 2023
|By Bryan Tipper

In pharmaceutical documentation using DITA XML, version control and change tracking play a crucial role in maintaining the integrity, accuracy, and compliance of drug documentation. These mechanisms enable pharmaceutical organizations to manage revisions, track changes, and ensure that drug documentation aligns with the latest regulatory requirements and scientific updates.

Version Control

Version control allows pharmaceutical organizations to maintain a history of changes made to drug documentation. Each document or topic in DITA XML can have a version attribute, which helps track different iterations. For instance, a drug formulation document may go through multiple versions as it’s updated or revised. This version history is essential for auditing, compliance, and ensuring that previous versions can be referenced if needed.

Change Tracking

Change tracking in DITA XML involves mechanisms for highlighting and documenting modifications made to drug documentation. It allows authors and reviewers to indicate where changes have occurred, whether it’s the addition of new dosage guidelines, updates to drug interactions, or revisions to warnings and precautions. Pharmaceutical organizations can use change tracking features to identify the nature and purpose of each modification, making it easier to understand the rationale behind changes and ensuring transparency in the documentation process.

Example:

Here’s an example of how version control and change tracking can be implemented in DITA XML:


<topic id="drug_formulation" version="1.0">
  <title>Drug Formulation</title>
  <body>
    <p>...

    <change-history>
      <revision>
        <date>2023-01-15</date>
        <author>Jane Smith</author>
        <description>Initial creation of the document.</description>
      </revision>
      <revision>
        <date>2023-03-10</date>
        <author>John Doe</author>
        <description>Updated dosage guidelines and warnings.</description>
      </revision>
    </change-history>
  </body>
</topic>

In this example, a DITA topic on “Drug Formulation” includes a change history section that tracks revisions, including the date, author, and description of each change. This information is invaluable for maintaining version control and understanding the evolution of the drug documentation.