Local-first QC & CMC utilities

Run the statistics your work depends on — right on your own machine.

Brynaxa builds small, exact desktop tools for regulated life sciences. The first computes ICH Q1E shelf-life and process capability, draws the plots, and writes the report — start to finish, on your computer.

Runs offline · your data stays on your machine · you keep the report
Stability regression — batch poolassay % vs. months
LSL 90.0% t = 24 mo shelf life 100 90 0 36 time (months)
ICH Q1E · poolability testedestimate: 24 months
The idea

One focused tool for the job in front of you — built around a single rule.

Your data stays put. Everything else follows from that: a calculation you can trace, and a report you keep.

Runs offline

No account, no upload, no cloud. The tool reads your files and writes your report on the machine in front of you.

A method you can trace

Published calculations that run the same way every time — a result you can check and defend, not a black box.

A report you own

Plain files — PDF, Excel, HTML — showing the method, the data, and the result together. Yours to review, archive, and file.

ICH Q1E · Cpk The flagship

Stability & QC Statistics Calculator

For QC and CMC scientists. Import your batch data; get the shelf-life estimate and the capability numbers — with the plots and the report to show your work.

  • Shelf-life by ICH Q1EFits the regression, tests whether batches can be pooled, and finds where the lower confidence bound meets your specification.
  • Process capabilityCp, Cpk, Pp and Ppk against your limits — with a clear read on whether the process is centered and capable.
  • Plots a reviewer can readRegression, confidence bands, spec limits, and capability views — drawn to drop straight into a report or a review.
  • A report, not just a numberMethod, inputs, and result together as PDF, Excel, or HTML — so the result can be checked, not just trusted.

Does one job well: the shelf-life curve and the capability indices, computed and reported locally — without a general-purpose statistics suite or a fragile spreadsheet. It supports the analysis you're already responsible for; it doesn't replace your validated process or your judgment.

Process capabilityCpk 1.42
LSL USL measured value
within spec · centeredcapable
What it draws

The plots come with the answer — ready to export.

Every result ships with the visuals behind it, so a reviewer sees how the number was reached, not just the number.

How it works

Four steps. One shell. Nothing uploaded.

Every Brynaxa tool follows the same path, so learning one means learning them all.

01

Select

Point the tool at your file or folder. It reads locally.

02

Analyze

The calculation runs on your machine, the same way every time.

03

Review

See the result, the plots, and the assumptions before anything is final.

04

Export

Save a report you own — PDF, Excel, or HTML — to keep and file.

The shelf

One shelf. Six tools. Each closes a specific gap.

Each runs on the same local-first shell and the same four steps, and each names the problem it solves — so you know at a glance whether it's for you.

QC / CMC

Stability & QC Statistics Calculator

The problemShelf-life and capability math ends up in a fragile spreadsheet or a general stats suite you rent by the seat.

Computes ICH Q1E shelf-life and Cp/Cpk on your machine, with the plots and a report to show the work.

Regulatory / medical writers

Submission Document Checker

The problemBroken links, missing bookmarks, and TOC errors surface at review — or after you file.

Scans your Word or PDF submission and flags them first, so the document is clean before it leaves your desk.

Clinical programmers

CDISC Dataset Converter

The problemMoving between XPT, Dataset-JSON, and Define-XML by hand is slow and easy to get subtly wrong.

Converts between the formats and checks the structure locally, so the deliverable is right the first time.

Programmers / data managers

Clinical Delivery Diff

The problemWhen a CRO sends a new delivery, it's hard to see what actually changed.

Compares two delivery folders and shows exactly what moved — files, structure, and records.

Quality assurance

Excel GxP Integrity Checker

The problemA dragged formula or an unlocked cell in a GxP workbook is a finding waiting to happen.

Flags broken formulas, unlocked cells, and data-integrity gaps before an audit does.

QA / document control

SOP Cross-Reference Checker

The problemSOPs and forms reference other documents that no longer exist or point to obsolete versions.

Traces every reference and flags the dead and obsolete ones across your document set.

Start with the calculator, or request any tool in the suite and we'll get you set up.

Principles

Three commitments, kept.

Your data stays yours

Offline by design. The tool works with your files where they already are, and nothing is sent anywhere.

The same answer every time

Results come from published methods, computed the same way every time — traceable and defensible.

Plain files, kept simple

Reports you own and archive in your own systems — not a portal you rent access to.

Access

Tell us what you'd run first.

Do stability or capability work and keep your data local? Request access and we'll get you set up.

Request access

or email hello@brynaxa.com