We build bespoke IoT sensors for pharmaceutical cold chain compliance — pharmacies, wholesalers, and care homes. Validated audit trails, 15-minute recording intervals, automated excursion alerts. MHRA, FDA, and EU GDP compliant.
Good Distribution Practice requires temperature recordings at least every 15 minutes. Many pharmacies and wholesalers still rely on manual min/max thermometers checked once a day — or worse, once a week. That's not a compliance programme. It's a hope-based strategy. One MHRA inspection, one AIFA audit, one FDA 483 observation, and the gap becomes a business risk. Continuous IoT monitoring replaces hope with data.
MHRA GDP guidelines require continuous temperature monitoring with documented evidence. Community pharmacies and wholesale distributors still using manual thermometers face increasing scrutiny during routine inspections.
Wireless temperature sensors recording every 5–15 minutes, streaming to a compliance dashboard with automated excursion alerts and audit-ready reports for MHRA inspectors.
MHRA GDP guidelines require continuous temperature monitoring with documented evidence. Community pharmacies and wholesale distributors still using manual thermometers face increasing scrutiny during routine inspections.
Wireless temperature sensors recording every 5–15 minutes, streaming to a compliance dashboard with automated excursion alerts and audit-ready reports for MHRA inspectors.
FDA 21 CFR Part 11 requires validated electronic records with full audit trails, user access controls, and system validation documentation. The compliance bar is higher — and so is the litigation risk after a temperature excursion.
Sensor architecture designed for Part 11 compliance: validated audit trails, role-based access, electronic signatures, and system validation documentation package.
EU GDP requires temperature monitoring during storage and transportation. Italy (AIFA), Spain (AEMPS), France (ANSM), and Germany (BfArM) each enforce locally — but many pharmacies across all markets still rely on manual logs.
Same sensor hardware, localised compliance dashboards per national authority. Deploy across EU operations from a single platform with regulation-specific report formats.
Precision wireless sensors designed for pharmaceutical environments — cold rooms, fridges, ambient storage, and transport containers.
Embedded software built for reliability — store-and-forward during connectivity loss, tamper-evident logging, OTA updates.
Powered by Paqett. Real-time readings, validated audit trails, automated excursion reports, and role-based access.
Full validation support — mapping studies, IQ/OQ/PQ documentation, and phased rollout across your sites.
Every solution runs on Paqett — our IoT device management platform. MQTT ingestion, validated audit trails, real-time dashboards, and OTA updates. Production-grade backend purpose-built for regulated environments.
Learn more about Paqett →Complete pharmaceutical monitoring system — sensors, validation documentation, dashboard. Fixed price, defined milestones.
Deploy to 3–5 sites. Validate the system in real pharmaceutical environments, then scale.
We embed in your team to own the technical direction of your monitoring infrastructure.
Former Amazon Robotics. BEng + MSc Robotics. One engineer who owns your project end-to-end — no committees, no layers.
Tell us about your storage facilities — we'll scope the system in a 30-minute call.