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Life Sciences: Monitoring Solutions for FDA Quality and Compliance

Protect critical research 24/7 and ensure compliance with FDA, ISO, GxP, and USP requirements in Life Science labs with Sonicu. From ambient room conditions to refrigerators, freezers, and incubators, Sonicu monitoring simplifies lab quality, safety, and compliance.

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Life Sciences-Grade Monitoring for Quality and Compliance

  • 01 Biopharma/Biotech Research and Development

    Temperature and environmental monitoring solutions that meet strict FDA requirements for developing medications and biologics. 

    Accelerate Development of Life-Saving Therapies

    Protect research that will drive therapeutic breakthroughs, and meet FDA requirements with Sonicu wireless monitoring. Digital sensors and probes, including first-to-market digital cryogenic and ultra-low temperature probes, are accurate to research tolerances and provide constant protection for valuable assets.

    • Meet FDA Food and Drug and 21 CFR Part 11 regulations for monitoring and reporting
    • Provide 24/7 protection for irreplaceable research samples with tiered escalation alarms sent to mobile devices
    • Ultra low and Cryogenic monitoring with all-digital temperature probes are calibrated to NIST standards for your most sensitive samples.
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  • 02 Clinical Research

    Standardize monitoring and centralize control across clinical research sites with Sonicu. 

    Eliminate Monitoring & Compliance Blind Spots at Clinical Research Sites.

    Monitor clinical research and study samples across multiple labs and study sites. Meeting FDA regulations and reporting requirements, managing disparate IT networks, and enabling simple implementation across locations are just several ways Sonicu solutions address needs in complex clinical research environments.

    • Standardize temperature and environmental monitoring and eliminate reporting blindspots across all research sites with one streamlined cloud-based solution.
    • Simplify implementation and avoid IT headaches, with plug-and-play pre-configured monitoring kits for fast and easy deployment, and flexible cellular connectivity options that keep monitoring solutions off local networks.
    • Streamline compliance with FDA regulations and research protocols. Solutions are designed to meet 21 CFR Part 11 and allow data integration with LIS/LIM and CTMS software.
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  • 03 University Research

    Protect irreplaceable temperature-sensitive research samples 24/7 with cloud-based, real-time monitoring. 

    Protect Irreplaceable Research with Always-On Monitoring

    Losing precious research samples due to temperature excursions can be devastating. Protect your research 24/7 and avoid loss with Sonicu; monitor refrigerators, freezers, cryogenics, and incubators throughout your lab, building, or campus. Support NIH and NSF grant quality requirements and help facilities and IT resources that are stretched thin save time and headaches.

    • Safeguard irreplaceable research samples 24/7 with tiered escalation alarms sent to your mobile device
    • Standardize and simplify with one cloud-based enterprise monitoring system. Allow new researchers to plug-in to Sonicu’s platform for fast and easy deployment.
    • Don’t let limited IT resources and network security requirements become a barrier. Flexible cellular connectivity options can keep wireless monitoring off local networks.
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  • 04 Government Research

    Addressing application, IT network security, and procurement specifications of government agencies

    With US-based manufacturing and live technical support, Sonicu monitoring solutions meet unique government agency requirements. Simplify security checklists with FedRAMP compliant cloud-based hosting and optional cellular connectivity to stay off local IT networks. Address limited staffing and procurement challenges with plug and play, pre-configured sensor kits and grant-friendly contracts and pricing options, that make monitoring acquisition and implementation a breeze. 

    • Streamline IT security with optional cellular connectivity to stay off local networks, and AWS East Region, FedRAMP compliant hosting and security. 
    • Speed through procurement processes with solutions that are pre-registered with SAM.gov and Trade Agreement Act (TAA) compliant.
    • Standardize monitoring across facilities and applications with one cloud-based enterprise solution with web-based dashboards and 24/7 protection for critical assets and environments.
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TRUSTED AND ACCREDITED GLOBALLY

Stress-free Regulatory Compliance

Take the stress and manual work out of compliance. Whether you're preparing for a Joint Commission inspection, a VFC site visit, or a food safety audit, our platform helps eliminate manual logging and reporting by fully automating your compliance program.

From logging and alerting to documentation and corrective actions, Sonicu generates audit-ready reports that meet the requirements of your specific regulatory agency and delivers them straight to your inbox. No binders. No scrambling. Just confidence that you’re covered.

Hit the easy button on compliance with Sonicu.

The Joint Commission

Healthcare facilities face staffing shortages, reimbursement challenges, and rising compliance demands. Maintaining the Joint Commission standards must be as easy and efficient as possible. Sonicu simplifies your path to compliance and accreditation with automated environmental monitoring, real-time alerts, and audit-ready reporting delivered to your inbox.

CDC Vaccines for Children (VFC)

Meeting CDC VFC program requirements doesn’t have to be complicated or time-consuming, especially when your time and resources are limited. Sonicu delivers a simple, proven solution to protect vaccine integrity and satisfy state reporting standards without adding to your team’s workload.

USP <797> and <800>

Sterile compounding and hazardous drug handling come with strict environmental control requirements. With a full suite of sensors and compliance-ready reports, Sonicu makes it easy to meet USP requirements for temperature, humidity, differential pressure, and cold storage while keeping your staff safe and inspectors satisfied.

FDA

From 21 CFR Part 11 to audit trails and IQ/OQ validation, Sonicu simplifies FDA compliance. Our platform, designed from the ground up to meet FDA manufacturing requirements, includes security across solutions. Sonicu combines AWS cloud hosting, validated software, and e-signature support to meet electronic recordkeeping and data integrity requirements in regulated manufacturing environments.

HACCP

Every food service operation and kitchen needs a HACCP plan, but relying on clipboards and manual logs puts your compliance and reputation at risk. Sonicu makes it easy to automate your critical control point monitoring with wireless temperature sensors and cloud-based corrective action logs.

OSHA

As OSHA expands enforcement around heat stress, Sonicu helps you stay ahead of workplace safety compliance. Our wireless sensors track temperature, humidity, and calculate heat index automatically, helping you identify and respond to dangerous conditions before they impact your team.

With real-time alerts, digital logs, and cloud-based reporting, you’ll be equipped to meet current and emerging OSHA standards without increasing manual workload

Protect Precious Research Samples 24/7

Maintain required temperature and other environmental parameters 24/7. SoniCloud is a secure cloud-based platform that automates compliance reporting, delivers critical data and alerts to your mobile app, and will help ensure the right person is getting the right data at the right time to protect your research. SoniCloud offers flexible and IT-friendly networking capabilities, allowing data transmission to the cloud by 4G cellular, WiFi or Ethernet.
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Meet Regulatory Requirements, Be Prepared for Audits

Designed to help your lab meet compliance and quality standards, Sonicu solutions automates compliance. Sonicu is the leading provider of monitoring tools for room temperature, humidity, air pressure differential and more. SoniCloud provides your team easy access to cloud-based compliance reporting that helps to eliminate manual logging, and improving the efficiency to obtain, review, and respond to environmental data from your research. Sonicu solutions support a wide range of regulatory requirements, including FDA Food and Drug, CGMP, 21 CFR Part 11, and more.

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Trust Sonicu for Temperature and Environmental Monitoring

Sonicu has thousands of customers in all 50 states and serves Healthcare, Health Sciences, Pharmaceutical and Food service industries. Customers trust Sonicu to monitor cold storage temperature, ambient room condition temperature and humidity, and air pressure differential.

Safeguard Research, Reduce Compliance Risks; Eliminate Manual Logging Processes
Protect irreplaceable research samples address facility and IT resource challenges. Trust Sonicu to automate manual logging and reporting processes to safeguard your research, and improve quality, efficiency, and safety. 

FDA Compliance Made Easy

Meet your compliance requirements and be audit-ready, with  cloud-based automated data logging and compliance and available IQ/OQ validation. Solutions help meet FDA 21 CFR Part 11, cGMP, FDA Food and Drug regulations, and more.

Protect Data with Powerful Redundancy

Don’t let data gaps in reporting interfere with your critical research. DataSync technology helps ensure your records always remain complete with redundant data storage and transmission to protect your lab even during power and connectivity interruptions. 

Ensure Alerts Received by Right Person at the Right Time, 24/7

Cut through unnecessary noise, and avoid alarm fatigue, with SMART Alarm Handler and the SoniCloud Mobile App. Built-in sensor buffers and customizable alarm thresholds manage alarm delays to give you control of when your team is notified on your mobile device. 

Simplify and Standardize with a Single Platform

Sonicu has breadth and depth in monitoring and compliance solutions designed for Life Science research labs. From temperature, power, humidity, to air pressure differential, we can consolidate all monitoring applications, across your enterprise, with one seamless and scalable solution. 

Implementation and Deployment the Fast and Easy Way

Flexible connectivity options simplify IT, including Cellular (off-local-network), Wi-Fi, SoniLink (LPWA),  and Ethernet. Implementation tools and pre-configured plug-and-play sensor kits help you get up and running in less than 10 minutes!

Tight Budgets and Limited Capital, No Problem

Sonicu makes procurement processes painless, with flexible financing options and pre-approved contracting terms. Don’t let tight budgets be a barrier to the monitoring and compliance solution your lab needs to move your research forward. 

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.