TERMINUS reads the logger data, identifies the excursion, runs the Arrhenius assessment against your own stability data and returns a QA/QP recommendation — with the audit trail already attached.
Every excursion review answers the same four questions. The work is not the thinking — it is the assembling. That is the part TERMINUS takes.
Logger files and ambient sensor data are read as they come, without retyping into a sheet.
Time above and below the labelled range, with the exposure window isolated to the minute.
Arrhenius assessment with activation energy from your own ICH Q1A stability studies, then a post-exposure shelf-life simulation — not a rule of thumb.
A recommendation with the reasoning and the audit trail attached. The decision stays yours; the assembling does not.
A 2–8 °C shipment spends 1 h 30 min above 8 °C, peaking at 9.3 °C. The question QA has to answer is not whether the limit was crossed — the logger says that. It is what the exposure did to the remaining stability.
Activation energy comes from the stability studies for that product, not from a generic constant. The post-exposure simulation returns 10 days of shelf life lost, which moves the expiry on the label from 12 Mar 2028 to 02 Mar 2028.
That last line is the one an inspector reads. It is also the line a spreadsheet almost never produces, because the spreadsheet stops at “excursion: yes”.
Illustrative example built on simulated logger data. Your own figures depend on your product, your stability data and your lane.
| Step | With TERMINUS |
|---|---|
| Logger data pulled and pasted into a sheet | Read directly |
| Excursion window worked out by eye | Isolated from the raw series |
| Ea looked up, sometimes assumed | Sourced from your ICH Q1A studies |
| Impact judged qualitatively | Post-exposure shelf life simulated |
| Justification written from memory | Audit trail generated with the decision |
TERMINUS does not replace the systems you already run. It does the assessment that sits between the logger and the QA decision — the part that today lives in a spreadsheet, an email thread and one person's memory.
A 30-minute working session on a real case from your lane — your data, your stability studies, your call at the end.
