Most GxP sites still split the job in two:
Monitoring for day-to-day control.
Validation for mapping, PQ, and inspection evidence.
That split creates extra hardware, duplicate work, and gaps when an auditor asks: show me the continuous story of this environment.
EVMS — Environmental Validation and Monitoring System — closes that gap.
It is a Pharma 4.0 GxP IoT platform that unifies:
- Real-time monitoring of temperature, humidity, and room differential pressure
- Validation workflows (mapping, excursions, evidence packages)
- Data integrity controls aligned with 21 CFR Part 11, GMP, and GDP
From environment → sensors → LoRaWAN → EVMS → audit-ready evidence.
Why EVMS is the solution:
- One system for monitoring and validation
- Faster response to deviations with centralized alerts and reports
- Less manual effort, stronger traceability for FDA / EMA / WHO expectations
ATloge.com develops GxP IoT Solutions so regulated environments stay controlled — and inspection-ready.