CMC Portfolio Control

Why I built it

Teams must often combine MS Project schedules, Smartsheet trackers, CDMO deliverables, batch and stability signals, and one-page leadership reviews. Usually they do this by hand. I built this tool to make that rollup without manual work.

This tool started from my work at Novavax. See the role →

What it does

• Shows the schedule structure, milestone health, and status with links to evidence in one view.
• Gives data for portfolio reviews, timing tradeoffs, and decisions about when to escalate.
• Improves the quality of handoffs between functions from one review to the next.
• Leadership reports use the same data and logic as the daily work.

What goes in

MS Project schedules, milestone owners, dependency chains, RAID signals, Smartsheet execution status, and readiness signals with links to their sources.

What comes out

Power BI dashboards, milestone heat maps, timeline summaries, KPI rollups, one-pagers, and review packs for the leadership team.

What it changes

Leadership sees one clear portfolio status. Nobody has to collect status by hand, open separate files, or make the same report two times.

How it stays inside the rules

What it is for

Portfolio reports and milestone rollups for leadership review. The tool builds them from schedules, trackers, and CDMO deliverables. It is for reports only, and it only reads data from source systems.

What it never does

This is a reporting layer, outside the GMP boundary. Some tiles link to batch records or stability reports. For these tiles, the traceability link is the feature that matters for compliance. The source document is the record, and the dashboard is a view of it.

Who decides

The tool makes no decision automatically. Each leadership tile links to its source artifact, so the reviewer checks the record and not the summary.

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FDA draft guidance · EU GMP Annex 22

Where companies can use AI in regulated CMC work →

What already exists

• Power BI, Tableau: Visuals and KPI rollups for the data that they receive
• Smartsheet, Veeva Vault: Sources of truth for execution status and controlled content

The gap it targets

In this industry, teams usually rebuild portfolio dashboards by hand in each cycle. Also, a reviewer cannot trace the number on a tile to the batch record or stability report behind it. The gap is not visualization. The gap is audit-grade lineage from each tile to its source document.

What it is not

It is not a new BI tool. It adds connections and traceability to the BI tools that the company already licenses.

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.