Achieve Absolute Precision with GDP Compliant Cold Storage
Protect your pharmaceutical inventory with an enterprise-grade monitoring platform designed for Good Distribution Practice. TrueCold eliminates manual errors and ensures your life-saving products remain within strict temperature boundaries during every second of storage.
- Full FDA 21 CFR Part 11 Compliance
- Real-time Automated Audit Logging
- Proactive Deviation Management
Schedule Compliance Review
Book a technical walkthrough with our cold chain compliance team today.
Defining Excellence in Cold Storage
GDP compliant cold storage represents the gold standard in pharmaceutical distribution. It goes beyond simple cooling, encompassing a holistic system of validated equipment, rigorous documentation, and continuous environmental monitoring to ensure that drug products retain their safety and efficacy through the entire storage lifecycle.
NIST-Traceable Calibration
Every sensor in our ecosystem undergoes rigorous NIST-traceable calibration to ensure measurements meet strict global regulatory standards.
Automated Reporting
Eliminate paper trails with digital GxP logs that generate instantaneous reports for inspectors and internal quality audits.
Deviation Analysis
Advanced root-cause analysis tools help QA teams identify exactly when and why temperature excursions occurred in the storage facility.
The Compliance Playbook
Map Storage Environment
Identify hot and cold spots through initial temperature mapping to determine optimal placement for permanent monitoring sensors.
Deploy Validated Sensors
Install high-precision wireless monitoring hardware that connects directly to our secure, cloud-based TrueCold data management portal.
Enable Automated Alarms
Configure multi-level escalation protocols that notify quality managers instantly via SMS or email if conditions threaten product integrity.
Total Control Over Your Pharmaceutical Storage
Maintaining a GDP compliant cold storage facility requires more than just cooling; it requires intelligence. TrueCold provides the granular data needed to justify every release decision, ensuring that high-value biologics and vaccines never lose their potency due to environmental neglect.
The TrueCold Advantage
Audit-Ready Documentation
Stop fearing regulatory inspections. Our platform maintains a permanent, unalterable record of all temperature data and user interactions for effortless compliance.
Request Pricing →Enterprise Scalability
Whether you manage a single walk-in freezer or a global network of distribution centers, TrueCold centralizes all your compliance data into one dashboard.
Compliance FAQ
How does TrueCold support 21 CFR Part 11?
Is the monitoring system validated for GxP?
What happens if the Wi-Fi or power fails?
Ready to Secure Your Cold Chain?
Join the leading pharmaceutical providers who trust TrueCold for their critical GDP compliant cold storage monitoring and validation needs.