Pharmaceutical organizations employ several strategies to ensure that manufacturing documentation remains up-to-date and aligned with manufacturing processes using DITA.

Continuous Review and Revision Tracking

One key approach is to establish a continuous review process within DITA. Pharmaceutical companies can use metadata and versioning features to track topics’ revision history. When manufacturing processes change, subject matter experts can review and update the relevant documentation. DITA maintains an audit trail, recording when a topic was last reviewed and by whom. This ensures that changes are properly documented and allows organizations to monitor the currency of their manufacturing documentation.

Automated Content Validation

DITA also supports automated checks and alerts, which are invaluable for keeping documentation aligned with manufacturing processes. Automated scripts can be configured to validate content against predefined criteria. For instance, if a manufacturing process is updated or a new quality standard is introduced, automated checks can flag documentation that requires revision. This proactive approach ensures that documentation remains accurate and compliant without manual intervention.

Example:

Here’s an example of how DITA facilitates continuous review and automated content validation:

<topic id="manufacturing_process">
  <title>Manufacturing Process</title>
  <version>2.1</version>
  <last-reviewed>2023-11-10</last-reviewed>
  <reviewed-by>Dr. Smith</reviewed-by>
  <content>...
  <alerts>
    <check type="compliance" standard="GMP" />
    <check type="version" expected="2.2" />
    <check type="links" />
  </alerts>

In this example, a DITA topic represents a manufacturing process. It includes version information, the date of the last review, and the reviewer’s name. Additionally, it has automated checks for compliance with Good Manufacturing Practices (GMP), version alignment, and broken links. If the content fails any of these checks, it will trigger an alert, prompting a review and potential revision to maintain alignment with manufacturing processes and standards.