Temperature excursion management, with every alarm turned into a cited disposition in hours
Every temperature alarm becomes a cited release-or-reject decision in hours, with every earlier leg counted.
See one case, screen by screen ↓A logger alarms in transit, the consignee puts the pallet on hold, and the procedure gives distribution quality 24 hours to decide. The answer depends on facts spread across five places: the logger files, the CMR or air waybill, the product’s stability summary, the shipper’s qualification report and the carrier’s incident e-mail.
Most of the time goes on finding and lining those up — and on the part that is easiest to get wrong. Time out of range is cumulative: a 35-minute excursion in the packing hall last week counts against the same allowance as tonight’s door-open. When the batch’s earlier legs are not added up, a batch can be released past its budget; when nobody is sure, good stock waits, and replacement shipments get booked that were never needed.
Estimated split of QA time for one excursion, by hand and with the solution — about 3.5 hours today, about 1.2 hours with the agents.
Six specialist agents read the loggers, count the stability allowance and draft the decision; a GDP quality lead signs.
At 02:24 a product probe on a pallet of Veltrimab prefilled syringes reads above 8 °C on the road from Leiden to Madrid. Here is what happens next, screen by screen, in the working solution.
Dana opens the alarm wall: 412 shipments in transit, 2 new alarms overnight, €9.55 M of stock on hold. Six alarms are open and three are ready for her signature, each with its own 24-hour clock. The lane pulse shows where excursions keep happening, and the stock on hold is broken down by site.
“Each tile is one alarm: the logger trace against the label range, the batch’s stability budget, the recommendation and the 24-hour clock.”
Batch VL26-0388, Plant 3 — Leiden to Solano Farma, Madrid, with Polar Freight: €2.88 M on hold since the consignee received it at 06:40. The temperature record shows the top-layer probe peaking at 12.6 °C, 2 h 46 min above 8 °C. Eight documents are already in the evidence pack — logger files, the CMR, the stability summary, the batch ledger, the packaging qualification, the carrier’s incident report, the SOP and the EU GDP guidelines — not yet read.
The logger reader works through 2 logger files, 391 readings each. The shipment matcher ties SH-77502 to batch VL26-0388 and its 1,920 syringes. The stability budget keeper looks up the allowance, the packaging qualification checker compares the event with what the shipper was tested for, and the disposition writer and deviation drafter wait for their findings.
Each agent’s step is shown as it runs, with what it found.
The batch already spent 35 minutes out of range in the packing hall at Plant 3 on Sep 30, and none in the cold room after that. Adding this shipment’s 2 h 46 min, VL26-0388 has used 3 h 21 min of Veltrimab’s 72-hour allowance at up to 25 °C — 68 h 39 min left.
Stability summary SR-VLT-014, 6.3: “Time outside 2–8 °C is cumulative across storage and every transport leg and does not reset when the product is returned to 2–8 °C.”
Never below 2 °C — the lowest reading was 4.2 °C, on the bottom layer. Inside the stability allowance — 12.6 °C is under the 25 °C ceiling. The shipper behaved as qualified: the carrier reports a 52-minute door-open at its Bordeaux cross-dock, and the 60-minute door-open test reached 12.9 °C on the top layer. A complete record: no gaps. The disposition writer recommends release to saleable stock at 94 % confidence.
The recommendation lists what follows it: write 3 h 21 min to the batch ledger, send the carrier a deviation notice (EU GDP 9.2), set the ERP batch to unrestricted and tell logistics the replacement is not needed.
Dana clicks the citation on the 72-hour allowance. The stability summary opens beside the assessment at section 6, with Table 6 highlighted: 8.1 °C to 25 °C, cumulative up to 72 hours over the shelf life; above 25 °C not supported; below 0 °C, of any duration, reject.
“Read by the agents, never changed. Every number in the assessment points back to a passage like this one.”
The cause was the carrier’s, so the deviation drafter writes notice CN-26-0412 to Polar Freight: the readings, the times, the 52-minute door-open at Bordeaux, and a request under section 7.3 of the quality agreement for the root cause and corrective action by Oct 14, 2026. Dana can edit it before it goes.
“Every fact in the draft comes from the evidence pack; edit freely before sending.”
Release is the recommended choice, with quarantine and reject next to it. Dana chooses release and signs with her password under the stated meaning — “I release this stock to saleable stock.” — for 1,920 syringes of batch VL26-0388. The signature’s meaning, her name, the date and the time are stored with the record.
Signed at 08:14, an hour and a half after the pallet went on hold. The ERP batch status changes to unrestricted, 3 h 21 min is written to the batch ledger, and logistics hears at once that no replacement is needed. The activity trail records each agent step and Dana’s signature, with who and when.
“Released · ERP batch VL26-0388 unrestricted · ledger updated · logistics told”
The dashboard shows alarms by outcome, median hours from hold to decision against the 24-hour target, excursion rates by carrier and why excursions happen — door-open or dwell at a hub or dock leads at 31 %, then terminal holds in heat on ambient lanes at 22 %. That is the evidence for the next conversation with a carrier.
The same alarm, seen by the people who carry it — the signer, the Responsible Person, the stability scientist and the control tower.
Six specialist agents read the loggers, count the stability allowance and draft the decision; a GDP quality lead signs.
Reads every logger file for the shipment, CSV or PDF, product probes and ambient probes, and works out the peak, the minutes out of range, gaps and the mean kinetic temperature.
Matches the alarm to the shipment record — CMR, air waybill or bill of lading — and to the batch, the units on the pallet, the lane, the carrier and the packaging.
Looks up the product’s approved excursion allowance and adds this excursion to every earlier storage period and leg of the batch.
Checks that the shipper was qualified for the season and duration, and whether the event — a door-open, a delay, conditioning — is inside what was tested.
Drafts the recommendation — release, quarantine or reject — with the calculation, the reasons, the conditions and a confidence, applying the disposition rules in order.
When the cause is a process failure, drafts the deviation with a proposed CAPA; when it is the carrier, drafts the carrier notice under the quality agreement.
Decides and signs. The agents propose; a named person decides.
Distribution quality can ask in plain words — or tell it what to change. Every answer points to its passage.
Why is EX-2614 safe to release?
The Veltrimab syringes reached 12.6 °C for 2 h 46 min above 8 °C and never went below 2 °C. Veltrimab may spend up to 72 hours in total at up to 25 °C. Adding the 35 minutes at Plant 3 on Sep 30, batch VL26-0388 has used 3 h 21 min — 4.7 %. The cause was a 52-minute door-open at the Bordeaux cross-dock, inside what the shipper was qualified for. The decision is yours.
Which lanes cause the most excursions?
Over the last 90 days, per 100 shipments: Leiden → Singapore with AeroCold, 13.6 %, hub transfer; Memphis → Phoenix with Meridian, 11.8 %, terminal holds in heat; Venlo → Oslo with CoolRoute, 10.5 %, gel pack conditioning; Venlo → Dublin with Polar, 10.3 %, reefer failure. The Oslo lane needs the conditioning step enforced at Venlo, and the Phoenix lane should move to a temperature-controlled service from May to October.
Send batches with under 20 % budget left to Priya
Done. The rule “Low budget goes to the stability scientist” now triggers at 20 % of the allowance left (was 10 %). It adds one batch today: VL26-0355, 8 h 50 min of 72 h left, now goes to Priya Raman, next to VL26-0362, which was already routed to her. The change is in Settings and on the audit trail.
Draft the deviation for EX-2611
Drafted DEV-26-1179 (major): the top-layer logger read −1.8 °C, below 0 °C for 65 minutes, because gel packs left freezer F2 at 13:42 and the shipper was closed at 13:51 — against 2 hours of conditioning in the work instruction. Proposed CAPA: a conditioning timer and pack-out sign-off at the Venlo bench, evening-shift training by Oct 21. Review it and file it to the quality system.
13 screens from the working solution, on its sample data. Pick one to see it large.
The disposition rules, the signers and the thresholds are settings, taken from your procedure.
| Setting | Default | Choose from |
|---|---|---|
| Freeze means reject | Always | Always on, for any reading below 0 °C on a product that must not be frozen |
| Data gaps go to quarantine | Over 30 min | 15 · 30 · 60 min |
| Low budget goes to the stability scientist | Under 10 % left | 10 · 20 · 30 % |
| Returns need full storage records | On — otherwise reject (EU GDP 6.3) | On · Off |
| Close ambient-only alarms | On | On · Off |
| Who signs EU dispositions | Dana Okafor | Dana Okafor · Omar Haddad |
| Who signs US dispositions | Lena Ortiz | Lena Ortiz · Dana Okafor |
| Second signature on rejects and returns | Omar Haddad | Omar Haddad · Dana Okafor |
Every figure is labelled: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample shipments · “target” = the design goal, measured in the live solution · “estimated” = our estimate · Regulations named as context: EU Good Distribution Practice guidelines (2013/C 343/01), 21 CFR 211.142 and 211.150, USP <659>. People, companies and products named on this page are fictional — characters and sample data in the working solution.
Software that takes a temperature alarm from the data logger to a signed disposition — release, quarantine or reject — with the evidence behind it. The Temperature Excursion Disposition Assistant adds agents that read the logger files, match the shipment and batch, count the stability allowance, check the packaging qualification and draft the decision for QA to sign.
The disposition writer applies the rules in order: a freeze means reject; a data gap over the limit means quarantine; a return without complete storage records means reject; an exceeded allowance means reject. Otherwise it recommends release when the batch is inside its allowance and the shipper behaved as qualified. It recommends; a named person decides and signs.
Yes. The stability budget keeper adds every earlier storage period and transport leg of the batch from the batch ledger, and never resets the total. If a period has no records, it says the total cannot be calculated instead of guessing.
For products with a controlled room temperature label, the logger reader calculates the mean kinetic temperature and the budget keeper checks it against the limit — for example 24.2 °C against 25 °C on a Talmirex tablet shipment in the working solution.
The named signer for the region — the GDP quality lead in the EU, QA release in the US — signs with an electronic signature. In the EU, rejects and decisions on returns also need the Responsible Person’s second signature, and low-budget or unusual cases go to the stability scientist before a decision.
No. Logger files, shipment records and stability documents are read and cited, never changed. The batch status in the ERP and the batch ledger are updated only after a person signs, and deviations and carrier notices are drafts until a person files or sends them.
Yes. Every recommendation can be overridden, with the reason recorded, and every agent step and every signature is on the activity trail. The thresholds and signers are settings your quality team owns.
The Agentic Solution Engine builds and deploys it from your requirements — your excursion SOP, stability summaries, packaging qualifications and a sample of past alarms — and it goes live once every quality gate has passed. We will walk you through it on your own excursions first.
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1-min filmWe’ll run the Temperature Excursion Disposition Assistant on a sample of your own past alarms.