Managing review comments and feedback within DITA for pharmaceutical technical content is critical to ensure the accuracy, compliance, and quality of documentation. DITA offers a structured approach to handle comments and suggestions from stakeholders, allowing for efficient collaboration and document improvement.

Comment Tagging and Tracking

DITA enables content developers and reviewers to tag comments directly within the XML structure. Comments can be associated with specific elements or sections of the content, providing precise context. For instance, regulatory experts can highlight areas that require clarification, while content developers can indicate proposed changes. DITA’s tagging and tracking mechanisms ensure that comments are not lost and can be easily revisited during the review process.

Comment Resolution Workflow

Pharmaceutical technical content often undergoes multiple rounds of reviews and revisions. DITA allows for the establishment of a systematic comment resolution workflow. Comments can be categorized, assigned to responsible parties, and tracked to completion. This ensures that all feedback, whether from regulatory experts, drug manufacturers, or content developers, is addressed and incorporated into the final documentation, leading to a more robust and compliant output.

Example:

Here’s an example of how DITA manages review comments and feedback for pharmaceutical technical content:

<topic id="drug_labeling">
  <title>**Drug Labeling**</title>
  <version>2.6</version>
  <last-reviewed>2023-12-05</last-reviewed>
  <reviewed-by>Dr. Maria Rodriguez</reviewed-by>
  <content>...
  <comments>
    <comment author="Regulator" status="open">Clarify dosing instructions.</comment>
    <comment author="PharmaCo" status="closed">Updated adverse event data.</comment>
  </comments>
  <resolution>
    <resolved-comment comment-id="2" resolved-by="ContentDev" date="2023-12-08">Revised dosing instructions as per regulator's request.</resolved-comment>
  </resolution>
</topic>

In this example, a DITA topic titled “Drug Labeling” includes version information, last review date, comments from stakeholders, and a comment resolution record. DITA’s structured approach ensures that comments are managed systematically, helping pharmaceutical organizations and regulatory experts collaborate effectively and achieve documentation excellence.