Work

A-3.1

FDA submission formatter for a pharmaceutical lab

The problem

In vitro release testing produces long-format spreadsheets from the bench: one row per cell, per time point, per run. The FDA wants the same data in a specific SAS transport layout described on a single page of a guidance document. For every pivotal and validation study, an analyst was reshaping those workbooks by hand, then checking them by hand, then hoping.

What we built

A browser tool with two pages, because the two kinds of study start differently. The pivotal page takes one workbook with a blinded test and a blinded reference. The validation page takes one workbook per run, for repeatability, discrimination, and robustness, all at once. Both pages run the same pivot and the same checks, so the output layout is identical and any error is named with its row and reason.

• Reads the lab's own export format directly, no re-keying
• Produces the required layout as a download, ready for the submission package
• Flags missing time points, mismatched labels, and out-of-range values before they reach a reviewer
• Ships with test workbooks and expected outputs so QA can verify it independently

The offline guarantee

Release data is confidential, so the tool was designed to make no network requests at all. Spreadsheets are read by the browser's own file reader, pivoted in memory, and rendered locally. The only thing that leaves the tab is the file the analyst chooses to download. A content security policy in the page enforces it, and the same four files can be copied to a shared drive and opened with no server in the picture.

Source is available for review on request, so colleagues, QA, or IT can satisfy themselves about exactly what the tool does.