CoolCheck delivers a reliable, 21 CFR part 11 compliant, and fully automated temperature monitoring solution for pharmaceutical manufacturing facilities. It provides continuous monitoring, proactive alert notifications, automated reporting, and secure digital data storage to safeguard product quality and maintain regulatory compliance at all times.
In pharmaceutical manufacturing, precise temperature and humidity control is critical to protect product quality and meet GMP requirements. Cleanrooms, production areas, stability chambers, cold rooms, and storage zones must always remain within defined limits. Automated temperature monitoring provides continuous oversight, reducing risk, preventing waste, and ensuring full regulatory compliance..
How CoolCheck Supports Pharmaceutical Temperature Compliance
CoolCheck is a wireless temperature and humidity monitoring system for pharmaceutical manufacturing and life science environments. Precision sensors monitor fridges, freezers, stability chambers, cold rooms, warehouses, and production areas, with real-time data and instant alerts delivered via the Kelsius platform. All readings and events are securely time-stamped and recorded, supporting GMP and GxP compliance, FDA 21 CFR Part 11 requirements, and audit readiness, with ISO 9001 and ISO 14001 accredited systems and full IQ/OQ documentation available.
Why choose CoolCheck Pharmaceutical Manufacturing?
Real-time monitoring and alerts
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Wireless sensors continuously monitor temperature and humidity across cleanrooms, fridges, freezers, stability chambers, cold rooms, and warehouses. Live dashboards provide real-time visibility across single or multi-site pharmaceutical facilities.
Instant alerts and risk control
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Customisable thresholds trigger immediate alerts via mobile app, email, or voice call when limits are breached. This enables rapid intervention, including out of hours, to protect product quality and reduce risk.
Automated compliance and reporting
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Temperature data is recorded automatically with secure, time-stamped audit trails. Digital reports are instantly available for inspections, audits, and regulatory review.
Centralised, Cloud-Based Control
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A single online dashboard provides real-time oversight of all monitored locations. Data is securely stored long-term for compliance, trend analysis, and audit readiness.
Scalable, efficient deployment
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The wireless system installs quickly with no hard-wired infrastructure or operational disruption. It scales easily from a single area to multi-site pharmaceutical operations.
Industry-leading efficacy and cost-saving
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Automated monitoring reduces staff workload, human error, and product loss.
Paper records are eliminated.,
Annual calibration is included, and all Kelsius-manufactured equipment is covered by a lifetime warranty.
CoolCheck is designed to protect blood products, components and samples through a tamperproof, automated temperature monitoring system. CoolCheck closes the gaps in cold chain traceability, providing regulatory compliance and improved risk mitigation.
Sensors eliminate the need for manual temperature monitoring, eliminating paper and saving staff time spent on paperwork. CoolCheck is fully compliant with regulatory requirements.
Why choose CoolCheck for automated monitoring?
No paperwork
Protect patient health
Reduce waste
Full Audit Trail
Regulatory compliance
Clients
Trusted by the healthcare industry worldwide
Abertawe Bromorganwg HB
We installed the Kelsius temperature monitoring system in the Blood Transfusion Departments across the Abertawe Bromorganwg HB in 2011. Since that time the system have paid for itself multiple times over.
The system provides 24-hour temperature monitoring of all temperature-controlled units protecting around 500 units of blood and tens of thousands of pounds worth of blood products.
It allows us to become aware of any potential issue before it becomes a problem so we can be proactive in dealing with it.
I would highly recommend the Kelsius system to anyone who currently has a need for temperature monitoring.
Barbara Sullivan
Bloodtransfusion Manager, Abertawe Bro Morganwg University Health Board, Wales
Maidstone and Tunbridge Wells
The robust alarm alert system allows us to take corrective actions well on time allowing stock to be relocated and thus reducing financial impact of the loss of high value refrigerated products.
Kelsius web portal is user-friendly and offers on-site/off-site access to real-time temperature data, weekly reports, graphs and allows complete auditing of temperature data and has the provision to add more sensors. Calibration Certificates are traceable to a UKAS Certificate.
With Kelsius in place, we have increased confidence in product quality and patient safety. Moreover the digital temperature monitoring system has already paid for itself since installation by helping save time and reducing product loss.
Satish Kumar
Pharmacy Technician
Central Manchester University Hospitals
Using the Kelsius system, temperature readings are easily accessible from a central web portal that allows the data to be displayed in the form of tables and graphs, providing a full audit trail that is compliant with UKAS.
The Kelsius system ultimately contributes to the high quality of our service and patient safety. It helps financially by ensuring that expensive commercial kits and reagents aren’t lost due to temperature damage. Staff time is more productive in delivering our immunology service.
Andy Moran
Chief Biomedical Scientist
St. Vincents University Hospital
"The Kelsius system has provided reliable temperature monitoring in 90 medication fridges across the hospital and makes 24-hour monitoring in all areas possible.
It has ensured rapid response to deviation from recommended temperatures and provided important data about fridges, allowing trends to be identified. In the future we hope to expand our monitoring system to include room temperature and humidity monitoring.
The potential financial savings within a three month period was approximately €120,000 if all stock involved had to be discarded."
Caitriona Reilly & Paul Tighe
Pharmacy Department
Letterkenny General Hospital
"When faced with cold chain failure, the system on an annual basis more than pays for itself contributing significantly to product quality assurance and overall patient safety".
Colm Devine
Chief Pharmacist
Torbay and South Devon Trust
“The Kelsius system has allowed us peace of mind that our fridges and incubators are being monitored in real time and let us know when they deviate from the allowed parameters.
We have installed Kelsius throughout our Pharmaceutical facility to cover all units including ambient monitoring of our Warehouse.
Live and historical Data is available at all times which allows us to cover any inspections and audits carried out.
Follow up service is excellent and an annual service is included.
Highly recommended by our team.”
Dr Alison Webber
Head of Microbiology
Forth Valley Royal Hospital
We needed a system that protects pharmaceutical products and met the requirements stipulated by the MHRA which could easily be incorporated within our quality management system.
The sensors have also allowed Pharmacy to be proactive and reactive to any temperature deviations, allowing stock to be relocated and reducing the financial impact of the loss of high value refrigerated products and the effect that this would have to patient safety/patient treatment.
The actual system is user-friendly and weekly reports, graphs and reports can be accessed and interrogated thoroughly.
We have recommended Kelsius to other NHS Health Boards and Pharmacies and would continue to do so in the future.
Daniel Kelly
Quality Assurance
FAQ
Pharmaceutical Temperature Monitoring FAQs
What is pharmaceutical temperature monitoring?
Pharmaceutical temperature monitoring involves the continuous measurement and recording of environmental conditions (such as temperature and humidity) in drug manufacturing and storage areas. Automated systems like CoolCheck ensure that conditions remain within defined limits and immediately issue alerts if any deviation occurs. This guarantees that products are kept under proper conditions throughout production and storage.
What environments and equipment can CoolCheck monitor?
CoolCheck can monitor virtually all temperature-controlled environments in a pharmaceutical manufacturing setting. This includes production areas and cleanrooms, refrigerators and freezers, stability chambers, cold rooms, warehouses, and other critical storage or process areas. In practice, any zone or equipment that needs temperature or humidity control can be equipped with wireless CoolCheck sensors – allowing you to track ambient conditions and cold chain storage on one unified platform.
How does CoolCheck simplify regulatory audits?
CoolCheck makes regulatory audits (whether by internal QA or agencies like the HPRA/MHRA/FDA) much easier by automatically capturing and organizing all your environmental monitoring data. Every reading is time-stamped and stored securely with a tamper-proof audit trail. You can instantly pull comprehensive PDF reports of historical data, alarm events, and corrective actions at the click of a button. This means when an audit or inspection happens, you already have all records readily available and audit-ready, without scrambling through paper logbooks. The system’s compliance with FDA 21 CFR Part 11 ensures your digital records and signatures are acceptable to regulators, giving you full confidence during inspections.
How are alerts delivered if a condition goes out of range?
Whenever a temperature or humidity reading goes outside your set limits, CoolCheck immediately notifies the responsible personnel. On-site, it can trigger local audible/visual alarms (e.g. siren and flashing light) to alert staff in the area. Simultaneously, the system sends remote alerts via multiple channels: you’ll receive an instant push notification on the Kelsius mobile app, and it can send out email alerts, SMS text messages, and even automated voice calls until the issue is acknowledged. You can configure escalation rules so that if one person doesn’t respond, alerts automatically go to the next contact, ensuring that no critical alert is missed.
Does CoolCheck replace manual temperature logs?
Yes. CoolCheck completely automates the temperature logging process, eliminating the need for manual record-keeping. The system continuously records all readings digitally, so you no longer must fill out paper log sheets – in fact, it eliminates the need for paper records entirely along with the costs of storing or printing those logs. All data is stored securely online and can be viewed or exported at any time, so your team can focus on higher-value tasks instead of daily logging chores. With CoolCheck’s digital logs and audit-ready reports, you’ll always be prepared for compliance checks without maintaining any physical paperwork.
Kelsius works with partners across the industry and is accredited for full regulatory compliance.
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