How are medical and clinical content reviewed and validated in DITA documentation?

In DITA documentation for medical and clinical content, a systematic review and validation process is essential to ensure accuracy, compliance, and quality. This process involves several key steps that help maintain the integrity of healthcare documentation.

One crucial step is the creation of a review and validation plan. This plan outlines the objectives, responsibilities, and timelines for the review process. It defines who will review the content, what specific aspects will be evaluated (e.g., medical accuracy, regulatory compliance, language, and formatting), and the criteria for approval. The plan also identifies the tools and technologies to be used in the review, such as DITA-aware content management systems that facilitate collaboration and version control.


Here is an example of a DITA-based review and validation plan:

<!-- Example of a DITA review and validation plan -->
  <objectives>Ensure medical accuracy and regulatory compliance</objectives>
  <responsibilities>Medical writers, subject matter experts, regulatory affairs team</responsibilities>
  <timeline>30 days</timeline>
  <criteria>Approval requires 100% medical accuracy and compliance with FDA guidelines.</criteria>
  <tools>DITA CCMS for collaborative review and version control</tools>

With this structured approach, DITA documentation can effectively manage the review and validation process for medical and clinical content, ensuring that it meets the highest standards for accuracy and compliance.