Cold chain IoT solutions give pharma companies and 3PLs one GxP-ready platform for real-time temperature, humidity, and location tracking with audit-ready data. Yalantis builds the sensor hardware and cloud software as one system, giving you one team and one reliable audit trail.
IoT Solutions for Cold Chain Logistics
Jahre
im Ingenieurwesen
Spezialisten
angestellt
IoT Experten
Jahre durchschnittlich
Kundenbindung
We build top-grade IoT solutions for leaders in various industries
Our certifications:
ISO 9001
ISO 27001
ISO 27701
ISO 13485
Cold chain IoT solutions we build
Not sure where your cold chain data breaks?
Tell us about your lanes, devices, and current tools. Our IoT engineers will find where readings get lost and which fix pays off first.
Сhallenges we solve with IoT cold chain management
Product loss found after delivery
IoT sensors stream readings to the platform and send an alert the moment a value leaves its range. Your team can reroute or re-ice the shipment while it can still be saved.
Audit findings on incomplete or editable data
We build 21 CFR Part 11 systems with time-stamped audit trails that nobody can alter. Inspectors see one validated record behind every release decision.
Data silos between carriers, 3PLs, and pharma clients
A shared data layer links your WMS, QMS, and client systems. Everyone works from the same shipment history, which gives you full supply chain visibility
Manual QA review of logger files
The platform flags excursions, matches data from every device, and builds audit-ready reports. This can cut manual QA effort by up to 90%.
Doubts about hardware and data integrity
Consumer-grade loggers are hard to defend in an audit. We use NIST-traceable sensors with validated firmware, so each reading holds up from the moment it’s recorded.
No proactive risk management
Without combined data, weak lanes and carriers stay hidden. Our analytics show where spoilage and wastage start, so you can fix the cause before the next shipment.
Why use IoT monitoring devices instead of disposable loggers
A disposable logger tells you what happened on the road. An active device tells you what is happening right now, while you can still act. The table shows how IoT cold chain monitoring compares with single-use loggers in daily cold chain processes.
| Kriterien | Disposable data loggers | Active IoT monitoring devices |
|
When you see the data |
After delivery, once someone reads the logger |
Continuous monitoring during storage and transport |
|
Response to an excursion |
The loss is confirmed after the fact |
A real-time alert arrives while the product can be saved |
|
Data handling |
Manual downloads and CSV files |
Automatic upload to a validated platform |
|
Audit readiness |
Printouts and scattered files |
ALCOA+ record with a full audit trail |
|
Location data |
Usually none |
GPS or cell location with every reading |
|
Reuse |
One trip, then discarded |
Reusable across many trips and lanes |
Ready to move beyond disposable loggers?
Pick one lane, and we’ll show you what live monitoring changes there.
IoT solutions for cold chain logistics in your sector
Facing an audit or a new quality agreement?
GxP and FSMA rules ask for different evidence. Share your requirements, and our validation team will show how the platform covers each one.
Our approach to building a cold chain platform with real-time visibility
Discovery and user requirements
We map your lanes, products, and current tools. The result is a User Requirements Specification and a risk assessment that guide the whole project.
Validation planning
Our quality team writes the Validation Master Plan and defines what will be tested. This keeps the build aligned with GAMP 5 from day one.
Hardware and firmware
We select or design monitoring devices and write GxP firmware. Prototypes go through our Warsaw lab under the temperature fluctuations your shipments really face.
Platform and integrations
We build the cloud platform, alert rules, and dashboards. Then we connect them to your QMS, ERP, WMS, and carrier systems.
Qualification (IQ/OQ/PQ)
We run and document installation, operational, and performance qualification. You receive a complete package for internal QA and external audits.
Rollout und Support
We start with a pilot lane and then scale across your network. After go-live, we handle updates, change control, and revalidation.
Where does your cold chain project stand?
Maybe you already run a pilot, or you only have loggers and an audit date. Tell us what’s in place, and we’ll map the remaining work and the team it needs.
IoT technologies powering our cold chain solutions
Rust
C
C++
Kotlin
Zephyr
Linux-Kernel
Bootloader
ESP32
STM32
nRF52
Arduino
LoRaWAN
MQTT
BLE
LTE-M / NB-IoT
AWS IoT
Certifications & regulations we follow
FDA 21 CFR Part 11
EU GMP Annex 11
GAMP 5
ALCOA+
EU GDP guidelines
FSMA Rule 204
HACCP
GFSI
ISO 28000
DTLF
CISA / NIST
GS1 EPC/RFID
ISO 17363-17365
Why companies choose Yalantis for cold chain technologies
Demand keeps rising across the cold chain industry. Buyers across cold chain supply networks now expect IoT data they can trust in an audit. Here is what we bring to the table.
Validated by design
Our engineers work with GAMP 5, FDA 21 CFR Part 11, and ALCOA+ every day. We write validation documents alongside the code. Your QA team gets IQ, OQ, and PQ packages that match the system you actually run.
Software and hardware under one roof
Sensors, firmware, cloud platform, and integrations sit with one team, so there are no gaps between vendors when an auditor starts asking questions.
Internes F&E-Labor in Warschau
Our lab assembles boards, runs climate chamber tests, and checks battery life under real loads. Every prototype is tested before it reaches your trucks or your warehouse.
Integration-first approach
We connect your platform with SAP, Oracle, Veeva, Manhattan, and carrier APIs. Data moves both ways, so an excursion can put a batch on hold without anyone typing a line.
Certificates you can hand to an auditor
ISO 9001, ISO 27001, ISO 27701, and ISO 13485 cover how we deliver projects and handle data. Your supplier qualification goes faster.
Clients who stay for years
Our clients work with us for more than four years on average. We support, update, and revalidate your system as regulations and routes change.
Kundenstimmen
Cold chain logistics insights
Wie Kältespeicher-IoT-Lösungen die Sicherheit und Einhaltung der Arzneimittellieferungen gewährleisten
Erfahren Sie, wie IoT-Lösungen in der Kältetransportkette Echtzeitüberwachung, Datenanalyse und Compliance-Kontrollen nutzen, um die Sicherheit und die Einhaltung der Vorschriften für verfälschbare Waren entlang der gesamten Lieferkette zu gewährleisten.
Wie man die pharmazeutische Etikettierung für temperaturempfindliche Sendungen verwalten kann
Die Überwindung der Einschränkungen von Papieretiketten in der Kältetransportlogistik mithilfe robuster, aktualisierbarer digitaler Displays für temperaturempfindliche Arzneimittel.
Wie man das Etikettierungsmanagement für multilinguale, mehrstufige klinische Studien vereinfacht
Erfahren Sie, wie die digitale Etikettierung bei klinischen Studien in mehreren Regionen eine effiziente Zusammenarbeit ermöglicht, die Verteilung von Materialien vereinfacht, sofortige Protokollaktualisierungen ermöglicht und auf Anfrage mehrsprachige Unterstützung bereitstellt.
Verwandte Dienstleistungen und Branchen
Häufig gestellte Fragen
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What are cold chain IoT solutions?
Cold chain IoT solutions use the internet of things to link sensors, gateways, and software that track product temperature during storage and transport. They send data to a central platform and raise an alert when a reading leaves its range. The stored records support audits and batch release. Together they give you continuous visibility of cold chain conditions without manual checks.
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What is a cold chain single source of truth platform?
It is one validated system that holds all temperature, location, and custody data for your products. Carriers, 3PLs, and pharma clients read from the same record instead of swapping spreadsheets. We build this platform on top of your existing WMS, ERP, and QMS, so each partner keeps its own tools while the data stays consistent.
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How do you support cold chain root cause investigation and excursion analysis?
When an excursion happens, our analytics module rebuilds the full shipment timeline. It overlays sensor readings with location, door events, and handoffs between carriers. Your QA team can see where and why the problem started and compare it with similar lanes. The findings go straight into a deviation or CAPA record in your QMS.
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How do you make your cold chain monitoring solutions GxP-compliant and audit-proof?
We deliver a fully validated system. Our team follows the GAMP 5 framework and provides documented evidence (IQ, OQ, and PQ) that your monitoring process is tested and controlled. Every change after go-live goes through change control. As a result, you face FDA or EMA inspections with a complete, consistent record.
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What is the business case for switching from disposable loggers to active monitoring devices?
Disposable loggers only confirm a loss once it has happened. Active devices send live alerts, so your team can step in and save the product. They also automate QA release decisions and can be reused across many trips. For high-value pharma loads, a single saved shipment often covers the return on investment.
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How do your cold chain software solutions integrate with our WMS, ERP, or QMS?
We build two-way APIs between our platform and systems like SAP, Oracle, Veeva, or Manhattan. Many clients come to us when their ERP can’t absorb real-time sensor data for pharmaceutical products. Once connected, a temperature excursion can open a quality event in the QMS or put a batch on hold in the WMS without manual steps.
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How do your solutions meet FDA 21 CFR Part 11 and ALCOA+ data integrity requirements?
Our platforms are designed for 21 CFR Part 11 from the start. Electronic records are time-stamped, secured, and linked to a full audit trail. Users sign GxP-critical release decisions with compliant electronic signatures. Each record meets ALCOA+ principles, so your data stays attributable, legible, contemporaneous, original, and accurate.
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What is the process for deploying and validating your cold chain monitoring platform?
We start with a User Requirements Specification and then write the Validation Master Plan. Next, we build and configure the system and run IQ, OQ, and PQ with full documentation. A pilot lane comes first. After a successful pilot, we scale the platform across your network and support it long term.
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Can your system monitor both in-transit shipments and GxP cold storage?
Yes. One GxP-validated platform covers remote monitoring of storage units such as freezers and cold rooms along with shipments on the road. You get one compliant record for the entire chain of custody. This removes data silos and makes product safety checks and audits of the whole temperature-controlled supply chain much simpler.
Erste Schritte mit Yalantis
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