UC-415
CMC Dossier and Authority Question Desk
Assembles Module 3 content from validated source records, tracks what changed since the last filing, and drafts authority answers.
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The Challenge
One health-authority question can hold a launch while staff hunt the batch data behind the answer. Source records sit across LIMS, the document system and site files, each under a different owner.
How It Works
- Reads Module 3 sections, LIMS results, batch records, specifications and past replies.
- Matches each dossier statement to its source record and flags where filed text has moved on.
- Gives the regulatory affairs lead a drafted response, every figure linked to its source.
What It Removes
- Hand-copying specification tables into dossier drafts
- Chasing site owners for the supporting batch record
- Re-reading past filings to find the agreed wording
Input Data RequirementseCTD Module 3 sections, LIMS results, batch records, approved specifications, change control records, prior health-authority correspondence
Output FormatDrafted dossier sections and question responses, statement-to-source traceability table, register of filed text that is now out of date
“The answer is in a batch record somewhere, and finding it and proving it is three weeks of a specialist's life”