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Confidently Meet FDA Environmental Monitoring Requirements

Whether you're storing pharmaceuticals or manufacturing critical components, Sonicu helps your operation stay FDA-compliant with real-time monitoring, automated reports, and validated data integrity.

Built on secure AWS infrastructure, our platform supports 21 CFR Part 11 with full audit trails, e-signatures, and non-editable logs so your quality team can be confident on inspection day.

Designed to automate compliance
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Meet FDA Monitoring Requirements with Ease

  • 01 Meet FDA Storage Guidelines with Confidence

    Ensure pharmaceuticals, laboratory, and food products are stored within the required environmental conditions.

    Environmental Monitoring That Keeps You FDA-Ready

    Sonicu’s 24/7 monitoring and data logging tools help regulated facilities stay compliant with FDA expectations for temperature, humidity, and pressure controls. Validated system with built-in compliance features for FDA-regulated storage

    • NIST-traceable sensors for validated accuracy
    • Continuous environmental monitoring
    • Configurable alarming for proactive risk mitigation
    See more
  • 02 Automated Reporting for FDA Audits

    Generate clean, time-stamped reports with just a few clicks, perfect for FDA reviews.

    Prove Compliance in Seconds

    With Sonicu, you don’t scramble for records during inspections. Our system generates audit-ready reports and maintains historical data securely in the cloud. Complies with 21 CFR Part 11 e-signature and timestamped recordkeeping.

    • PDF exports, CSV reports, and audit trail logs
    • Auto-archived for easy recordkeeping
    • Filter by asset, date range, or event type
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  • 03 SMART Alerts to Prevent Product Loss

    Prevent costly excursions with real-time, intelligent alerting.

    Act Before Deviations Become Disasters

    Avoid product spoilage or contamination with Sonicu’s SMART alarming. Receive alerts when conditions breach defined FDA thresholds, no matter where you are. Integrates with FDA-mandated QMS workflows to support corrective action documentation.

    • Escalation paths to reduce missed alerts
    • Multi-channel delivery (SMS, email, app, call)
    • Custom alert thresholds
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  • 04 24/7 Access via SoniCloud

    Monitor critical conditions anytime, anywhere with secure, cloud-based access.

    Facility Oversight at Your Fingertips

    FDA-regulated operations demand continuous visibility. With SoniCloud, your team can track every monitored point in real time and access compliance logs on demand. Hosted on secure AWS infrastructure to meet enterprise-level IT and FDA data standards

    • Remote access from desktop or mobile
    • Tiered permissions for QA, Ops, and Maintenance
    • DataSync feature protects log integrity, even during outages
    See more
  • 05 Guided Setup and Validation Options

    Our team helps configure and validate your system to meet FDA expectations.

    Built for Compliance From Day One

    We help you hit the ground running with FDA-aligned configuration, IQ/OQ options, and expert-led onboarding. IQ/OQ documentation and protocols included to support FDA validation and inspection readiness.

    • Validation packages available
    • Training for staff and admin users
    • Dedicated support team ensures smooth deployment
    See more
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TRUSTED AND ACCREDITED GLOBALLY

Meet Your FDA Monitoring Requirements

Whether you're storing vaccines, medications, or food, Sonicu helps you maintain compliance with FDA regulations by continuously monitoring key environmental conditions.

  • Monitor and log temperature, humidity, and air pressure
  • Ensure NIST-traceable sensor calibration
  • Maintain defensible audit trails for FDA inspections

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Protect Critical Inventory, Don’t Just Take Our Word for It

Sonicu customers depend on our advanced monitoring setup to stop product loss before it starts. In this video, hear firsthand how expert configuration, tiered alarms, and real-time data visibility helped one organization protect its most valuable inventory.

  • SMART alarms escalate if issues persist
  • Reports and alerts built into your workflow
  • Datasync to prevent any data loss during outages
Compliance Reporting Main View - March 2023

Protect Critical Inventory, Don’t Just Take Our Word for It

Sonicu customers depend on our advanced monitoring setup to stop product loss before it starts. In this video, hear firsthand how expert configuration, tiered alarms, and real-time data visibility helped one organization protect its most valuable inventory.

  • SMART alarms escalate if issues persist
  • Reports and alerts built into your workflow
  • Datasync to prevent any data loss during outages

Trusted Across Key Industries

  • 01 Healthcare

    Ensure Patient Safety and Regulatory Compliance with Confidence. Sonicu provides reliable, 24/7 monitoring for vaccines, labs, blood banks, and cleanroom environments, helping you protect patients and maintain critical standards. 

  • 02 Pharmacies

    Sonicu supports a wide range of pharmacy types by providing automated environmental monitoring solutions that ensure regulatory compliance, protect high-value medications, and reduce operational risk. From continuous temperature, humidity, and pressure monitoring, our platform gives you the tools to simplify compliance for USP, BoP, CDC, and more.

  • 03 Life Sciences

    Safeguard irreplaceable research while maintaining FDA Compliance with Lab-Grade Monitoring. Sonicu delivers precise temperature and environmental monitoring designed for sensitive research environments. Our platform supports FDA quality requirements with built-in electronic signatures, full compliance with 21 CFR Part 11.
  • 04 Food Safety

    End-to-End Food Safety Monitoring. From manufacturing to distribution and commercial kitchens, Sonicu helps protect food safety at every stage. Our real-time temperature monitoring, smart alerts, and automated digital logs support compliance with HACCP and FDA regulations, ensuring your food stays safe, your operation runs smoothly, and you're always inspection-ready.

  • 05 Industrial

    Scalable industrial monitoring solutions that help manufacturers, warehouses, and critical infrastructure operators protect equipment, maintain compliance, and avoid costly downtime. Monitor temperature, humidity, differential pressure, air quality, and more. Empower teams to improve safety, processes, and KPIs.
Healthcare Team
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Your Monitoring Questions. Answered Simply.
Trusted by hundreds of facilities to eliminate costly operational mishaps while improving compliance readiness.
Great Lakes Bay Health Centers
We were really impressed with the SNAP program and how easy it was to get all of our probes calibrated.
IU Health
Consolidating with one temperature monitoring provider helps us better manage our assets and our people.
Ohio University Innovation Center
Cost competitiveness, great customer service, great control over the monitoring system, and low maintenance. You can’t beat that.
MiraVista
Sonicu costs are considerably more reasonable than our historic system, as well as other competitors on the market. The equipment is robust but simple to learn and utilize.
Katherine Shaw Bethea Hospital

Our policy is to check temperatures on all our fridges and freezers twice a day. With small outlying clinics that aren’t staffed seven days a week, we’d come in Monday morning, hoping the temperatures held steady over the weekend. We needed visibility on the fridges, especially after the loss we just suffered.

Xytex
Having safe and secure storage provides reassurance that any future family building efforts will be protected. Sonicu gave us the ability to more easily put our head on the pillows and sleep easier at night knowing we had invested in a strong monitoring system.
Hendricks Regional Health
You don't even have to log onto Sonicu. It will tell you when you have a problem.
SUNY Downstate Pediatrics
I would definitely recommend the service because it makes temperature monitoring of vaccines so much easier.
Hancock Regional Hospital
Thanks to our monitoring and alerts with Sonicu, we saw that humidity levels in [a] new building kept rising into areas that were unacceptable for the sensitive work underway.
Lemaitre Vascular
[Sonicu] successfully prevented a serious situation from becoming catastrophic. I was alerted this morning that the temps are going up in one of my freezers. Sure enough, the hospital didn’t fill up the LN2 on time. At this point everything is back under control
Discount Drug Mart
There’s always that extra peace of mind when you’re able to see in real-time the power supply situation from your cell phone during a natural disaster.
UHS South Texas
The monitoring system makes it so much easier that we don’t have to get all dressed up in that bunny suit. We can simply pull up our phones and assess it.
Boy Scouts of America
We knew about temperature monitoring and had thought about it, but after we lost so much food it was like “Oh yeah, we absolutely have to do this." We have to feed a lot of hungry Scouts and knew we couldn’t afford another mishap that costs us thousands in lost food.
AMR Knoxville Weisgarber
The support team for Sonicu is by far the best I've ever encountered in my personal or work life.
Nyack Hospital
We have been trying to revamp our dashboard as a result of a loss of product when a user disregrded an alarm. Many additions and changes needed to be done and Matt patiently navigated me through that
DHL
Fast response and resolved my issue quickly!
University of Utah Health
I believe it was David and Matthew that helped me. I had to call several times with some issues as they arose. They were helpful, professional, and got the job done. You are lucky to have those guys!
CleanSlate Treatment Center
We saw other systems, but Sonicu had everything we knew was important to remove manual logging that we've been doing for far too long.
Community Health Center of Central Missouri

When we put the numbers in front of our leadership and showed them how much time we were going to save with a remote system and automated monitoring versus the time we used to spend managing the system, it was a no-brainer, and we pulled the trigger right away.

Hamilton County Health Dept
When we got the app, that was a game changer. It was helpful with the zones, it was helpful for looking at my alarms, making sure that everything was online. There are so many things that the app makes easier since it is so user-friendly.
Nomi Health
Speed is so important to us, and Sonicu has made everything fast and easy. It’s two minutes to install a probe, and then easy to connect to cellular and add my users in a few more minutes. I can get my teams up and running fast
Ohio Public School District
We ask our cooks to do so much, so it’s a relief to know they don’t have to keep those temperature logs anymore.
Speak With an Expert Today
Not sure where to start? Talk with a Sonicu professional to match your needs with the right equipment, software, and support. Call us at (317) 468-2345 or click below to connect.