Checklist7 min · 21 points · no sign-up
Cold-chain compliance checklist
An auditor is not testing your refrigeration. They are testing your record. These are the places a record fails, in roughly the order they get found.
01
Continuity of the record
- Is there a reading for every interval, including nights, weekends and shutdowns?
- When a gap exists, is it visibly a gap — or has it been silently interpolated into a smooth line?
- Are device timestamps recorded, or only the time the server received the data? These differ after an outage, and the difference matters.
- Is there a monotonic sequence number per device, so a missing record is detectable rather than invisible?
02
Integrity you can demonstrate
- Can a record be edited after the fact? If yes, is the edit logged with who and why?
- Is the device identity carried on every record, or attached at export time?
- Are calibration certificates linked to the device and the date range they cover?
- Can you show the firmware version that produced a given record?
03
Excursion handling
- Is the alert threshold defined per product, not per warehouse?
- Does the alert escalate when nobody acknowledges, and is the escalation chain written down?
- Is the acknowledgement recorded with a name and a timestamp?
- Is there a documented decision for what happens to stock after an excursion — and is it followed?
- Do mean-kinetic-temperature calculations exist where the product requires them?
04
Coverage of the whole chain
- Transit as well as storage — the gap is usually in a vehicle, not a chamber.
- Loading docks and staging areas, where product sits outside both systems.
- Door-open events, which explain excursions that otherwise look like equipment failure.
- The last mile, if you control it.
05
The export itself
- Can a non-technical person generate the report for an arbitrary date range without calling IT?
- Does the export state the device, the interval, the calibration status and the gaps, on its face?
- Is the raw data retained for the period your regulator requires, and is deletion after that documented?
- Have you tried producing last February's report, today, as a drill?
If you want a second pair of eyes
We will walk through this with you, free, for thirty minutes.
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- GSTIN 09CPBPD9064H1ZS
- Lucknow, India
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