BryNaxa Stability ● LIVE
Turn stability data into an ICH Q1E shelf-life estimate — regression, batch poolability, process capability, and control charts — then write the plots and the method into one report you can file. Installs in-house on any Windows machine you control — server or desktop.
What it produces.
BryNaxa Stability fits the regression, tests whether your batches pool, and finds the point where the lower confidence bound meets your specification — the shelf-life estimate, by ICH Q1E. It adds process capability (Cp, Cpk, Pp, Ppk) against your limits and control charts that catch points going out of trend, then writes the plots and the method into a single report.
- Shelf life, by ICH Q1E — regression fit, batch poolability, and where the lower confidence bound hits your spec.
- Process capability — Cp, Cpk, Pp and Ppk against your limits, with a clear read on whether the process is centered.
- Out-of-trend — control charts catch points going out of trend before they reach your summary.
- The plots — regression, capability, control chart, normal probability and residuals, drawn to go straight into a report.
- The report — method, inputs and results in one file, as PDF, Excel or HTML. Yours to keep and file.
Where it fits in the workflow.
QC and CMC teams responsible for stability programs and shelf-life justification. Load your batch data and you get the shelf life, the capability numbers, and the plots behind them — the statistics follow ICH Q1E and run the same way on every machine, so the numbers are traceable and defensible.
Everything stays on your machine.
Runs fully offline on any Windows machine you control — server or desktop. No account, no cloud, no telemetry — your files never leave your network. Every result comes from a published method computed the same way every time, so the same input always produces the same findings. You keep the report as a plain file in your own systems.
Capability by tier.
On-screen analysis is free, always. The filed HTML/Excel report includes 5 free exports (watermarked), after which a licence makes it clean and unlimited. The Validation Report is licensed from first use — no free run.
Download for Windows.
Install and run BryNaxa Stability in-house on any Windows machine you control — server or desktop. On-screen analysis is free; licensing is handled from inside the app, and your licence is bound to that machine.