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Qualified Controls
Qualified Controls is a US engineering firm specializing in Regulated Environmental Monitoring (REM): continuous, validated temperature, humidity, differential-pressure and CO2 monitoring systems for facilities that answer to auditors. It designs, installs, calibrates, validates (IQ/OQ/PQ) and supports the complete system under one contract — wireless sensors engineered and calibrated in-house, the MySirius cloud monitoring software, 24/7 alarm response, and audit-ready records built for FDA 21
Their llms.txt
The beginning of the file, from our validated copy saved 2026-10-24T12:26:56.145Z. Cached copy · Source on qualifiedcontrols.com
# Qualified Controls
> Qualified Controls is a US engineering firm specializing in Regulated Environmental Monitoring (REM): continuous, validated temperature, humidity, differential-pressure and CO2 monitoring systems for facilities that answer to auditors. It designs, installs, calibrates, validates (IQ/OQ/PQ) and supports the complete system under one contract — wireless sensors engineered and calibrated in-house, the MySirius cloud monitoring software, 24/7 alarm response, and audit-ready records built for FDA 21 CFR Part 11, USP <797>/<800>, CDC VFC, GxP, AABB, FSMA and HACCP.
- **Best fit for:** pharma and biotech GMP facilities, hospital and compounding pharmacies, blood banks and biobanks, vaccine storage, clinical and research laboratories, cleanrooms, food and beverage cold chain, cannabis cultivation.
- **What is monitored:** refrigerators, freezers and ultra-low freezers, incubators, cleanrooms, warehouses, stability chambers, cold rooms.
- **Credentials:** A2LA-accredited, ISO/IEC 17025, NIST-traceable calibration; temperature mapping and IQ/OQ/PQ validation authored in-house; ALCOA+ data integrity.
- **Commercial model:** purchase or Monitoring-as-a-Service subscription (hardware, software, calibration, validation upkeep and audit support in one fee).
- **Customers include:** BridgeBio, Novonesis, Versiti, Circle K (case studies on this site).
- **Based in:** Research Triangle Park, North Carolina. Serves facilities nationwide. Founded on 15+ years of metrology and monitoring field experience.
Contact: https://qualifiedcontrols.com/contact/
## Company
- [12-Point Environmental Monitoring System Gap Analysis](https://qualifiedcontrols.com/resources/environmental-monitoring-gap-analysis/)
- [AABB April 2026 Blood Bank Audit Readiness Checklist](https://qualifiedcontrols.com/resources/blood-bank-monitoring-checklist/)
- [About Qualified Controls | Monitoring, SOPs & Training](https://qualifiedcontrols.com/about/)
- [Blood Storage Temperature Excursion Investigation Kit](https://qualifiedcontrols.com/resources/blood-storage-excursion-investigation-kit/)
- [Calibration Readiness Checklist](https://qualifiedcontrols.com/calibration-readiness-checklist/)
- [Contact](https://qualifiedcontrols.com/contact/)
- [Qualified Controls - regulated environmental monitoring](https://qualifiedcontrols.com/)
- [Resources & Documentation](https://qualifiedcontrols.com/resources/)
## Technology
- [Digital Probes & Sensors](https://qualifiedcontrols.com/technology/digital-probes-and-sensors/)
- [LoRa® Wireless Sensors](https://qualifiedcontrols.com/technology/lora-sensors/)
- [MySirius Monitoring — Real-Time Environmental Monitoring Software](https://qualifiedcontrols.com/technology/mysirius-monitoring/)
- [Nano Sensors](https://qualifiedcontrols.com/technology/nano-sensors/)
- [Nova Sensors](https://qualifiedcontrols.com/technology/nova-sensors/)
- [Technology](https://qualifiedcontrols.com/technology/)
## Solutions
- [Blood & Biologic Storage M
…
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