Every major submission has one: the tracker. A sprawling spreadsheet listing every document, who is writing it, which review round it is in and when publishing needs it. It is the real nerve centre of the submission — and it lives in Excel for good reasons.
Key takeaways
- Trackers persist because they encode real operational knowledge — any replacement has to keep it.
- They break on versions, structure, dependencies, issues and history.
- The replacement keeps the grid and changes what sits underneath it.
- Switch at programme start, not in week nine of dossier assembly.
Walk into any regulatory operations team preparing a major submission and you will find the tracker: one or several spreadsheets listing every document in the dossier, the author, the review round, whether QC has seen it and when publishing needs it. Before building document tracking into DnXT Planner, we studied real NDA programme trackers closely, and came away with real respect for what they get right.
What the spreadsheet gets right
Every tracker we studied converged on the same insight: submissions are managed document by document, not section by section or milestone by milestone. Real trackers distinguish authoring, several review rounds, QC, QA and publishing readiness as separate stages with separate owners. And everyone can read them — a grid the whole team looks at in stand-up beats a sophisticated system only the project manager understands.
Where it breaks
The tracker is emailed, copied and merged by hand, so by week six there are three “current” versions and reconciliation becomes a standing meeting. It does not know what an eCTD section is, so “what is still missing for Module 3?” needs manual cross-referencing. Its dates are not connected, so when a clinical study report slips two weeks nothing downstream moves until someone notices. QC findings live in email or a second spreadsheet. And overwritten cells keep no history of who changed a status, when or why.
Keep the spreadsheet’s form. Fix its physics.
A document-level operations grid
In DnXT Planner each submission has a document-level grid with thirteen lifecycle fields per document: authoring status and owner, review rounds with named reviewers, QC, QA, publishing readiness and the dates that govern each stage. For any document, the standard eight-phase authoring ladder is generated in one step, so coordinators stop hand-typing the same task list hundreds of times. Tasks sit on a timeline with predecessors and percent-complete, and a milestone register connects document-level reality to the programme dates leadership reports on.
The migration question
Two notes on switching. The cost is real: teams have muscle memory in their spreadsheet, and the right moment to change is at programme start. And any tracker is only as good as the discipline of the people updating it — a purpose-built grid reduces the update burden, but what it removes entirely is the reconciliation burden: the hours spent working out which copy is true and whether the dates still hold together.
Bring your current tracker
We will show the same programme in DnXT Planner, with its documents, status and timeline.
