CMC Program Dashboard
Shows the same program status in three views: for leadership, for the PM, and for each CDMO.
Interactive walkthroughThis is a scripted walkthrough with synthetic data. It shows how the tool works without real program data.
Program A · recombinant protein vaccine · Phase 3
Overall status Watch
Drug substance PPQ at Site A is on schedule. The site released 2 of 3 batches.
Fill/finish PPQ at Site B is 3 weeks late because a line slot moved.
The BLA filing target stays the same if the third fill/finish batch runs before mid-November.
Decision needed this month: Approve a paid priority slot at Site B. This keeps the last PPQ batch in the November window.
- Next milestonePPQ complete: Nov 2026
- Filing targetBLA Q2 2027
- Open escalations1
Same record, three views Each view reads the same program data. The only change is the data that each audience can see.
Why I built it
Each meeting needs a different view of the same program. The leadership team needs a short status. The PM needs the follow-up for each owner. A CDMO review needs detail for that partner. Usually the PM must build the same story three times.
What it does
- Keeps the LT, PM, and CDMO views separate, but all three use the same data.
- Shows milestone status, timeline shifts, and actions in one view.
- Helps executive reviews and the follow-up on delivery.
- Keeps the views short enough to use in real meetings.
- What goes in
- Milestones, partner status, KPI rollups, changes in workstreams, open issues, and the review needs of each audience.
- What comes out
- LT, PM, and CDMO views; KPI snapshots; milestone rollups; and review screens that start with the actions.
- What it changes
- Each audience gets the correct level of detail. Nobody rebuilds the full picture each time, and the meeting does not get too much data.
How it stays inside the rules
- What it is for
- The tool shows the program status to each audience in a review forum. It is a presentation layer on top of the existing schedule and tracker data.
- What it never does
- Outside the GMP boundary. The tool shows existing records and applies no model judgement to quality data.
- Who decides
- The tool prepares the views for a review, and the forum makes the decision. The team filters the scope of each partner view before the team shares it.
- Risk level
- Low under FDA's draft AI framework (how much the output influences a decision × how serious that decision is)
- Guidance it follows
- FDA draft guidance
What already exists
- Power BI: Reports for leadership
- Smartsheet dashboards: Execution views for each team
- The gap it targets
- Three audiences need three levels of detail from one program status. Thus teams keep three decks, and by the second week the decks do not agree. One source with a view for each audience is a problem of information architecture, not of tools.
- What it is not
- It does not replace governance forums. It is the artifact that those forums read.
Do you build tools like this?
I am glad to compare notes: what worked, what a reviewer did not accept, and where AI should stay out of the decision.