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Qualified Controls Regulated Monitoring & Mapping

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Qualified Controls provides regulated environmental monitoring and mapping as one service, for refrigerators, freezers, ultra-low freezers, incubators, cleanrooms, cold rooms and warehouses. Monitoring: wireless sensors report continuously to a cloud platform with live dashboards and floor-plan views. Alarms go out by SMS, voice, email and mobile push, escalating by severity, zone and on-call schedule. Every reading, alarm, acknowledgement and configuration change is kept in a tamper-evident audit trail with electronic signatures, aligned with 21 CFR Part 11 and ALCOA+. Mapping and validation: mapping studies capture loaded, unloaded and recovery profiles to find hot and cold spots. The result is a signed report and a permanent sensor-placement plan. We author and execute IQ/OQ/PQ protocols. Calibration: NIST-traceable calibration, performed onsite and ISO 17025 accredited laboratories. With Hot-Swap service, pre-calibrated replacement sensors are swapped on site, so monitoring never stops. Built for pharma, biotech, hospital pharmacy, blood banks, biobanks, laboratories, CDMO, cold-chain logistics, and food operations.

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