PharmaCase
A real-world digital transformation of a pharmaceutical production site β from manual logs to intelligent automation.
CEO Insight
"We created MITE not just to monitor β but to empower pharmaceutical teams with actionable data, greater oversight, and confidence in compliance. Our platform adapts to your processes, not the other way around."
β CEO, MITE
Before MITE
- π Paper logs for temperature and humidity.
- β³ Delayed alarm response β issues discovered after product damage.
- π No centralized visibility β each chamber handled separately.
- π Risk of GMP violations and costly product loss.
After MITE IoT
- π‘ Wireless IIoT sensors (Wi-Fi / GSM / LoRaWAN / NB-IoT)
- π End-to-end cold chain traceability across facilities and transportation
- π§ Intelligent alerts based on dynamic thresholds and historical data, various dashboards, automatical reports
- π Seamless integration with existing systems - QMS, ERP, LIMS and audit workflows
- π Built-in data security and compliance with global GMP standards
Results After Implementation
- β 75% faster incident response
- β 0% spoiled batches due to environmental deviations
- β Real-time control over all storage zones (GxP, warehouse, fridges, transportation)
- β Reduced human error and reporting workload by 3+ FTEs
How MITE Works
A step-by-step transition to smart GMP compliance
MITE is designed specifically for regulated industries like pharmaceuticals, biotech, and healthcare. By integrating wireless sensors and automated validation processes, our platform eliminates manual risks and ensures full 21 CFR Part 11 and EU GMP Annex 11 compliance from day one.
Step 1: Identify risk zones
- Audit existing process risks
- Map cleanrooms, storage, and temperature-sensitive areas
- Define validation strategy and user needs
Step 2: Install sensors
- Deploy battery-powered wireless modules
- Monitor fridges, chambers, warehouses, HVAC
- Works in isolated and shielded rooms (metal, concrete)
Step 3: Go live & validate
- Enable real-time alerting
- Calibrate sensors and log user validation
- Start digital reporting and audit trails
Industrial IoT for Pharma β MITE in Action
MITE helps pharmaceutical teams reduce GMP risks, monitor critical zones in real time, and automate compliance workflows across cleanrooms, warehouses and transportation. Our platform supports GxP guidelines and simplifies audits for FDA 21 CFR Part 11 and EU Annex 11.
Whether you're upgrading legacy systems or starting your digital transformation, MITE offers validated, cloud-enabled IIoT tools to support FDA, EMA, and WHO compliance frameworks.