A biologic freezer drifts out of range at 02:00. Who knows?
By morning a single temperature excursion can mean a six-figure loss of destroyed product, a GxP violation, and a regulatory investigation. The product was fine. The alerting wasn’t. IRIS makes sure the right person is reached, escalates until someone acts, and proves every step for your inspectors.
Illustrative industry scenario — not a specific client.
- Destroyed product
- Six figures
- Regulatory exposure
- GxP violation + investigation
- Window to act
- minutes, at 2 AM
- With IRIS
- reached · acknowledged · proven
The problem
Three ways a cold-chain alert fails an audit
The sensor did its job. The alert didn’t reach anyone who could act — and there was nothing to show the auditor afterward.
Single channel
One SMS to one phone. If it’s on silent, out of coverage, or the person is off-shift, the excursion runs unwatched until morning.
No escalation
No reply, no fallback. Nothing climbs the on-call chain to a second responder or a supervisor while the temperature keeps drifting.
No proof
When the inspector asks “who was notified, when, and did they acknowledge?”, a delivery receipt from a CPaaS gateway isn’t an answer.
How IRIS maps
From excursion to audited resolution
The same stateful lifecycle that runs Seemoto’s monitoring — applied to your cold chain, your on-call chain, your audit.
Escalation that climbs the on-call chain
No acknowledgement in your configured window? IRIS escalates SMS → voice call → the next person — up to ~20 rounds — until a human responds. The excursion is never left to a silent phone.
Voice/IVR for the 2 AM call
When a text won’t wake someone, an automated call will. Keypad acknowledgement is captured and timestamped like every other step.
6 languages, per recipient
A multi-site EU cold chain spans languages. Each responder is reached in theirs — message templates adapt automatically.
Two-way acknowledgement
Recipients reply to acknowledge or escalate. IRIS knows the difference between “delivered” and “a human has it” — and only the second one resolves the alert.
Audit-ready event log
Every signal, dispatch, escalation round, reply and resolution is written append-only and tamper-evident — the evidence trail GxP/GMP investigations demand.
Configurable retention
Keep the proof for as long as your quality system requires, then expire it on policy. Retention is a setting, not a support ticket.
Built for GxP, not generic on-call
Mapped to GDP, Annex 1 and Part 11
Generic alerting stops at “we sent a message”. A pharma cold chain has to tie the excursion to a quality decision and leave a record an inspector accepts.
- Qualified-range excursions
Alerts fire against the qualified range for each chamber or shipment — not one global threshold — so a 2–8 °C fridge and a −70 °C freezer escalate on their own limits.
- Excursion → QA disposition
The timestamped trail — when the limit broke, who was reached, when they acknowledged — feeds the QA disposition and batch-release decision, not a guess the morning after.
- Part 11 / Annex 11 controls
The append-only, exportable event log supports your 21 CFR Part 11 and EU GMP Annex 11 electronic-record and audit-trail controls. You own the CSV; we provide the record.
Audit-ready by design
Evidence your inspectors will accept
IRIS produces the export a GxP/GMP audit asks for — every notification, escalation round, acknowledgement and resolution, timestamped and EU-resident. We give you the trail and the residency posture; your quality system owns validation. We don’t claim certifications we don’t hold.
- GxP / GMP audit export
- EU data residency by architecture
- Configurable retention
- GDPR Art. 15 / 17 · DPA
- Two-way acknowledgement proof
- STOP/START opt-out · 6 languages
Built by the team behind Seemoto — pharmaceutical environmental monitoring across 5 EU countries (NL, FI, DE, AT, ES).
IRIS is the alerting engine from that operation, rebuilt edge-native. The same engine delivered 1,431+ alerts in production before it became a product. We didn’t learn cold-chain alerting from a slide deck — we run it.
Read the Seemoto case studyPharma — frequently asked
Is IRIS a validated GxP system?
IRIS is designed to be audit-ready: it produces the tamper-evident, exportable event trail (who was notified, when, escalation rounds, acknowledgement, resolution) that GxP and GMP inspections look for — the electronic-record trail that supports 21 CFR Part 11 and EU GMP Annex 11 controls — and it runs on EU-resident infrastructure with configurable retention. Computer-system validation (CSV) is performed by you against your own SOPs and intended use — we provide the documentation, export formats and EU-residency posture to support it. IRIS does not itself hold a GMP certificate; your quality system does.
Does it integrate with our existing temperature monitoring?
Yes. IRIS doesn’t replace your monitoring — it’s the escalation and proof layer on top of it. Any sensor platform, BMS or monitoring system that can fire a webhook posts the excursion to one REST endpoint, and IRIS takes over routing, escalation and the audit trail. This is exactly how it runs behind Seemoto’s environmental monitoring.
Where does our data physically live?
On Cloudflare’s EU edge. Alert state lives in Durable Objects pinned to EU jurisdiction, so residency is structural rather than a contractual promise on a US cloud. A DPA is available and GDPR Art. 15 export / Art. 17 erasure are supported.
Never let a 2 AM excursion run unwatched
Start free with 1,000 credits — no credit card — or talk to us about a multi-site GxP rollout.