Pharma companies face unique challenges when submitting product labeling to regulatory bodies. One such challenge is managing complex document relationships and associated processes throughout the submission lifecycle.
Clearly defined document relationships ensure that consistency and accuracy are maintained across documents that share information. When the content of one labeling document changes, authors must be aware of the related documents that also require updating.
- Source document translated documents.
- CCDS local labels.
- Approved version of a submission previously submitted version(s) awaiting review.
- Prescriber information patient information.
The power of XML can be harnessed to efficiently manage submissions and associated content, processes, and data. By utilizing “semantic” relationships, similar sections can be linked across structured documents, facilitating detailed analysis and comparisons. This information can then be presented clearly and concisely via process dashboards.
Dashboards can track tasks and processes throughout the submission lifecycle, creating a detailed record of which stage each related document is at. While tracking the evolution of the document, dashboards also capture valuable metrics (e.g. timelines, who, what, where, and when).
i4i’s process dashboards within our ALiCE solution have been developed specifically to help pharma companies manage complex document relationships throughout the submission lifecycle.
Translation Dashboard: The Translation Dashboard manages the lifecycle of translation content both internally and externally. Structured content can be exported for translation partners, then re-imported with the structure intact. The update function assists translation services by identifying changes to source document content and highlighting sections that require updating.
CCDS Dashboard: The CCDS Dashboard manages and monitors the distribution and implementation of a new CCDS version to local or global affiliates. The Local CCDS Compliance Sheet compares CCDS content with local label content and can compare related content or tagged information across jurisdictions.
Variant Dashboard: The Variant Dashboard allows users to view the lifecycles of parallel submissions for the same product and merge changes made in approved submissions with mapped sections in previous submissions of the same document.
Global Labelling Dashboard: The Global Labelling Dashboard allows users to see relationships between related prescriber and patient information documents across jurisdictions. Information in one document can be compared to similar sections in other documents, ensuring consistency and compliance.
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