About Qualified Controls
Your partner in regulated environmental monitoring.
The technology. The procedures. The people behind every reading.
Qualified Controls brings system design, deployment, validation, SOP development, and eLearning training together to help regulated facilities protect what matters.
15+ yearsof metrology & monitoring experience
One partnerfor technology, process & training
Nationwidesupport for regulated facilities
Why We Exist
Protect the science.
Protect the product.
Equip the people.
A monitoring program is only as strong as the decisions it supports. The temperature of a vaccine freezer, the humidity in a compounding room, and the record a quality lead reviews at 2 a.m. all depend on technology, procedures, and people working together.
Qualified Controls was founded on more than 15 years of metrology and monitoring experience in regulated environments. We bring that experience to the complete program, from the first sensor specification to the way your team responds, documents, and improves.
“Compliance is an architecture, not a checkbox.”
What We Do
We engineer the entire
monitoring lifecycle.
Seven connected capabilities bring your equipment, records, procedures, and team into one coordinated program. We scope each engagement around the support your facility needs.
- 01
Design
Monitoring architecture shaped around your facility, critical assets, operating risks, and validation strategy.
Explore our technology - 02
Install
Sensor networks and gateways deployed across cold storage, cleanrooms, laboratories, and controlled environments.
Installation & deployment - 03
Commission
Network verification, alarm checks, and site acceptance connect the installed system to the way your team works.
Commissioning & onboarding - 04
Validate
IQ/OQ/PQ protocols, mapping studies, and documented testing establish evidence for your intended use.
Validation services - 05
Monitor
Continuous measurements, clear alarm escalation, and monitoring support keep your team connected to critical conditions.
Explore MySirius - 06
SOP Development
Practical standard operating procedures define monitoring responsibilities, alarm response, record review, and change control.
Discuss your SOP needs - 07
eLearning Training
Role-based digital learning connects your procedures to everyday monitoring tasks, onboarding, and refresher training.
Plan your training
One accountable engineering partner, from system design to confident daily operation.
The AAI Standard
How we hire. How we operate.
How we engineer.
Three principles guide every engagement: selfless attitude, technical aptitude, and unstoppable initiative.
Selfless Attitude
Client outcomes come first.
We design for your facility’s long-term needs. We give clear advice, including when the right answer takes more work.
Technical Aptitude
Rigor is the foundation.
We connect measurement expertise with operational context. Design decisions, test evidence, and documentation need to stand up to review.
Unstoppable Initiative
Act before a gap grows.
We flag problems, plan for changes, and keep work moving. Your team should know the next step and who owns it.
Trust & Traceability
Evidence behind the system.
People behind the commitment.
Traceable calibration, documented qualification, and controlled operating practices support a monitoring program your quality team can review.
Calibration with traceability
NIST-traceable calibration through ISO 17025-accredited laboratories, with certificates tied to your instruments.
Records built for review
Electronic-record controls and audit trails support your validation strategy and regulated workflows.
Procedures put into practice
SOP development and eLearning connect documented expectations with the people responsible for carrying them out.
Trusted by organizations across life sciences, healthcare, and food safety
Where We Operate
Rooted in Research Triangle Park.
Supporting you nationwide.
Our headquarters in Research Triangle Park, North Carolina, puts us close to the life-sciences and regulated manufacturing teams we serve. Our Chicago operations support customers across the central United States.
From these two centers, we coordinate field deployment, validation, monitoring support, and training for facilities across the continental U.S.
- Research Triangle Park, NCHeadquarters · Engineering
- Chicago, ILMidwest Operations
Continental U.S. operations
Regulated Temperature Monitoring, Explained
Your questions, answered.
Practical answers about Qualified Controls monitoring systems, SOP development, eLearning training, connectivity, and records for regulated facilities.
Do you offer SOP development for environmental monitoring?
Yes. Qualified Controls develops standard operating procedures for monitoring workflows, including responsibilities, alarm escalation, excursion response, record review, and change control. We work with your team to define the scope and prepare procedures for review and approval within your quality system.
What does eLearning training cover?
Our eLearning training supports the people who operate and oversee your monitoring program. Content can cover routine system use, alarm response, documentation, and role-specific procedures. We scope the audience, learning objectives, and delivery requirements with your team, including onboarding and refresher needs.
How many monitoring points can Qualified Controls support?
A typical first deployment is 40–100 points. Live deployments range from 5 points to 35,000 across a large multinational convenience retailer.
Can we monitor equipment we already own?
Yes. Qualified Controls retrofits refrigerators, freezers and incubators from any manufacturer, with no unit replacement or wiring into the equipment. Sensor and probe combinations cover −196 °C LN2 dewars, −80 °C ultra-low freezers, −20 °C freezers, 2–8 °C refrigerators, blood bank units, CO2 incubators, warehouses and cleanrooms.
Which electronic records and audit trails does it support?
Qualified Controls supports 21 CFR Part 11 and EU Annex 11 electronic records and audit trails, with continuous recording and documentation for regulated healthcare, life-science and food operations.
Is the Qualified Controls monitoring system cloud-hosted or available on-premises?
Both options are available; cloud is recommended. The cloud platform runs on Microsoft Azure on the US East Coast, with redundant infrastructure, continuous backups and stated availability of 99.99%. Audit-trail and data retention is 10+ years.
What happens if the network connection is lost?
Sensors buffer up to 10,000 readings locally and backfill when connectivity returns. A 4G cellular failover option is available.
Will the sensors use our Wi-Fi, and how much IT time is needed?
LoRa SPY sensors communicate through a LoRa gateway without joining facility Wi-Fi. Gateway connectivity depends on the selected hardware; Ethernet, Wi-Fi and cellular options are available across the range. Typical IT involvement is about 2 hours for network access and required firewall port configuration.
How are calibration and validation handled?
Annual Hot Swap calibrated-sensor exchange supplies NIST-traceable, ISO 17025 calibration certificates. Qualified Controls authors and executes IQ/OQ/PQ documentation and offers validation services.
Can the monitoring reflect product conditions?
Qualified Controls can supply physical glycol or glass-bead buffers. Qualified Controls also offers a proprietary option to simulate product conditions using validated glycol simulations. The simulated effect can be switched on or off.
Explore pricing and deployment options, the REM knowledge hub, or talk to a specialist.
Build Your Next Step
A stronger monitoring program
starts with a clear picture.
Review your monitoring practices across six REM objectives. Get a readiness snapshot, then request a detailed report with priority actions and evidence to verify.
10 questions. 3 minutes. Save your progress.