Version control and change tracking are integral aspects of managing pharmacovigilance documentation using DITA XML. These mechanisms enable pharmaceutical organizations to maintain the integrity, compliance, and accuracy of their documentation over time.

Version Control

DITA allows organizations to implement version control for their documentation. Each DITA topic can include version information, indicating the document’s revision or update status. This ensures that users can easily identify the most recent version of a document and track the changes made between different versions.

Change Tracking

Change tracking in DITA is crucial for pharmacovigilance documentation. When updates or revisions are made to a document, DITA enables organizations to record these changes, including who made the changes and when. This change tracking functionality ensures transparency and accountability, which is especially important in a regulated industry like pharmaceuticals.

Example:

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

<topic id="safety-assessment">
  <title>Safety Assessment</title>
  <version>2.0</version>
  <last-updated>2023-11-10</last-updated>
  <updated-by>Jane Smith</updated-by>
  <content>...
  <changes>
    <change>
      <date>2023-11-05</date>
      <description>Updated adverse event reporting section.</description>
      <updated-by>John Doe</updated-by>
    </change>
    <change>
      <date>2023-11-10</date>
      <description>Revised risk assessment guidelines.</description>
      <updated-by>Jane Smith</updated-by>
    </change>
  </changes>

In this DITA topic, version control is implemented with version information and change tracking with a list of changes made to the document, including dates and descriptions of each update. This information helps users understand the document’s history and ensures compliance with regulatory requirements.