Temperature excursion management that turns every logger alarm into a cited release-or-reject call in hours
Every temperature alarm turned into a cited release-or-reject call in hours.
See one case, screen by screen ↓Software that takes a temperature alarm on a pharmaceutical shipment from stock on hold to a documented, signed disposition. Temperature Excursion Management adds six agents that read the logger files, match the batch, count its stability budget across every leg, check the shipper qualification and draft a cited release, quarantine or reject for the GDP quality lead to sign.
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When a data logger on a pharmaceutical shipment alarms, the stock goes on hold until quality decides. A GDP specialist downloads the logger file, finds the shipment and the batch, looks up the product's approved excursion allowance in the stability summary, adds up every earlier period the batch spent out of range, checks whether the shipper was qualified for what happened and writes the disposition — usually over one to two days, while the consignee waits and logistics wonders whether to ship a replacement.
The risk sits in the arithmetic. Time out of range is cumulative and never resets, but the earlier legs live in different places — the packing hall, a cold room monitor, an earlier shipment, a customer's fridge. Miss one and a batch that has already used its allowance goes back to saleable stock. A freeze on a product that must not be frozen, a logger gap at a hub, or a return without full storage records each changes the answer, and every decision has to be documented and signed.
Estimated split of elapsed hours for one alarm, by hand and with the solution. The total with the solution is the solution's 3.6-hour target.
Six specialist agents read the loggers, count the stability budget across every leg and draft the decision; a GDP quality lead signs.
At 02:24 on Oct 7 a logger on a pallet of Veltrimab 150 mg/mL prefilled syringes — batch VL26-0388, 1,920 syringes, €2.88 M, on the road from Plant 3 in Leiden to Solano Farma in Madrid — goes above 8 °C. Here is what happens next, screen by screen, in the working solution.
Dana's alarm wall shows the logger feed live with 412 shipments in transit, six open alarms and €9.55 M of stock on hold. Each alarm is one tile: the logger trace against the label range, the stability budget, the recommendation and the 24-hour clock. The new one is EX-2614: Veltrimab PFS, 12.6 °C, Plant 3 → Solano Farma, Polar Freight — stability budget not yet counted, allowance 72 h at ≤ 25 °C.
Beside the wall, the batches closest to their budget: “time out of range is cumulative and never resets”.
The logger reader takes both logger files, 391 readings each: peak 12.6 °C, 2 h 46 min out of range. The shipment matcher ties them to SH-77502, batch VL26-0388, 1,920 syringes, Polar Freight. The stability budget keeper reads the allowance — 72 h at ≤ 25 °C — and adds the earlier legs: 35 min, total 3 h 21 min. The packaging qualification checker and the disposition writer follow.
Each step shows on the tile as it runs, with what it found.
The budget meter fills: 3 h 21 min of 72 h used, 68 h 39 min left — 95%. The reason reads “Highest reading 12.6 °C for 2 h 46 min above 8 °C, never below 2 °C”. The tile moves to Ready for signature with Release · 91% and 22 h 30 min left on the clock.
“EX-2614 assessed — release · 91% · the decision is yours”
Dana opens the alarm. The temperature record plots the top-layer logger LG-4471 at 12.6 °C and the bottom-layer LG-4472 against the 2–8 °C band; the lowest reading on any product probe is 4.2 °C. Below it, the batch's time out of range leg by leg: 35 min in the packing hall at Plant 3 on Sep 30, 0 min in the cold room, 2 h 46 min on this shipment. The logger rows sit open beside it.
Veltrimab stability summary SR-VLT-014: time outside 2–8 °C “is cumulative across storage and every transport leg and does not reset”.
Polar Freight's incident report says the trailer doors were open for 52 minutes at its Bordeaux cross-dock. Packaging qualification PQ-0217 for the PalletCool 1200 shows that in the 60-minute door-open challenge the top-layer probe reached 12.9 °C and was back below 8 °C within 3 h 10 min. Each of the four reasons for release cites its passage, and a click opens it.
“Read by the agents, never changed. Every number in the assessment points back to a passage like this one.”
Because the cause was the carrier's, the deviation drafter writes carrier deviation notice CN-26-0412 to Polar Freight: what the loggers recorded, when the doors were open, and a request under section 7.3 of the quality agreement for the root cause and corrective action for door-open time at cross-docks by Oct 14, 2026. Dana can edit it before it goes.
Dana chooses Release, as recommended. The signature dialog states its meaning — “I release this stock to saleable stock” — for Veltrimab 150 mg/mL prefilled syringe, batch VL26-0388, 1,920 syringes, and asks for her password. Choosing differently from the recommendation would ask her to say why.
“Signature meaning, name, date and time are stored with the record.”
The alarm closes: “Released to saleable stock · e-signed by Dana Okafor · Oct 7 08:14”. The ERP batch status is set to unrestricted, 3 h 21 min is written to the batch ledger for VL26-0388, and Sam Patel's logistics control tower hears that no replacement is needed.
EX-2611 is a different call. Veltrimab 100 mg autoinjectors, batch VA26-0142, 2,400 pens, read −1.8 °C and stayed below 0 °C for 65 minutes. The packing record shows gel packs out of freezer F2 at 13:42 and the shipper closed at 13:51, against two hours of conditioning in work instruction DC-114. Reject · 97%, with deviation DEV-26-1179 (major) drafted; a reject needs Omar Haddad's second signature as Responsible Person.
“The freeze rule applies. Veltrimab must not be frozen — the time budget does not matter for this decision.”
The same alarm, seen by the five people who carry it — what their week looked like, and what it looks like now.
Six specialist agents read the loggers, count the stability budget across every leg and draft the decision; a GDP quality lead signs.
Reads every logger file for the shipment, CSV or PDF, product and ambient probes alike, and works out the peak, the minutes out of range, any 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, then reports what is used, what is left and any rule that applies — freeze, ceiling temperature or MKT limit.
Checks that the shipper was qualified for the season and duration, and whether the event — a door-open, a delay, gel pack conditioning — is inside what was tested.
Applies the disposition rules in order and drafts release, quarantine or reject with the calculation, the reasons, the conditions and a confidence, every statement cited.
When a process failed, drafts the deviation with a proposed CAPA; when the carrier caused it, drafts the carrier deviation notice under the quality agreement.
Decides and signs. The agents propose; a named person decides.
Ask in plain words — or tell it what to change. Every answer points to the logger file, stability summary, ledger or qualification it came from.
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 Cargo 13.6% (hub transfer), Memphis → Phoenix with Meridian Express 11.8% (terminal holds in heat), Venlo → Oslo with CoolRoute 10.5% (gel pack conditioning), Venlo → Dublin with Polar Freight 10.3% (reefer failure). The Oslo lane needs the conditioning step enforced at Venlo; 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 VL26-0355 — 8 h 50 min of 72 h left, 12% — next to VL26-0362, which was already routed to Priya Raman. 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 from SOP QA-GDP-031, who signs and where the data comes from are settings, and every change is on the audit trail.
| Setting | Default | Choose from |
|---|---|---|
| Freeze means reject | Always | Any reading below 0 °C for a product that must not be frozen — locked |
| Data gaps go to quarantine | Longer than 30 min | 15 min · 30 min · 60 min |
| Low budget goes to the stability scientist | Under 10% of the allowance left | 10% · 20% · 30% |
| Returns need full storage records | On — otherwise reject (EU GDP 6.3) | On · Off |
| Close ambient-only alarms | On — close with a note when every product probe stayed in range | On · Off |
| EU dispositions signed by | Dana Okafor | Dana Okafor · Omar Haddad |
| US dispositions signed by | Lena Ortiz | Lena Ortiz · Dana Okafor |
| Second signature on rejects and returns | Omar Haddad, Responsible Person | 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 shipment data · “target” = the design goal, measured in the live solution · “estimated” = our estimate · “typical” = published figures (IQVIA Institute, 2019 Biopharma Cold Chain Logistics Survey — about $35 B a year lost to temperature-control failures and 44.6% of respondents reporting multiple excursions a year; Eupry — 8 to 14 days for a traditional excursion investigation, a vendor figure). Regulatory context: EU Good Distribution Practice guidelines 2013/C 343/01, 21 CFR 211.142 and 211.150. People, companies, products, batches and shipments named on this page are fictional — characters and sample data in the working solution.
Software that takes a temperature alarm on a pharmaceutical shipment from stock on hold to a documented, signed disposition. Temperature Excursion Management adds six agents that read the logger files, match the batch, count its stability budget across every leg, check the shipper qualification and draft a cited release, quarantine or reject for the GDP quality lead to sign.
The stability budget keeper reads the product's approved allowance from its stability summary — for example 72 h cumulative at ≤ 25 °C — and adds this excursion to every earlier storage period and transport leg in the batch ledger. Time out of range never resets. If any period has no records, it says the total cannot be calculated instead of guessing.
The rules are applied in order. A reading below 0 °C on a product that must not be frozen means reject. A product logger gap longer than the set limit — 30 minutes by default — keeps the stock in quarantine until a second record covers it. A return without storage records for the whole time is recommended for rejection, and a reject needs the Responsible Person's second signature.
Yes. For controlled room temperature products the logger reader calculates the mean kinetic temperature, and the recommendation weighs it against the 25 °C limit and the labelled excursion range — on the sample US shipment, 24.2 °C with a peak of 31.4 °C.
No. The agents recommend and draft; they never sign, release stock, change a product allowance or file a deviation unreviewed. The GDP quality lead or QA release signs, the Responsible Person adds a second signature to EU rejects and returns, and overriding the recommendation needs a reason.
Yes. The data gap limit, the low-budget threshold for consulting the stability scientist, the returns rule, closing ambient-only alarms, and who signs in each region are settings, and every change is on the audit trail. The freeze rule is always applied.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your excursion SOP, stability summaries, packaging qualifications and a sample of past logger files — and it goes live once every quality gate has passed. We will walk you through it on your own past excursions first.
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