Validated GxP Solutions

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

1

Map Storage Environment

Identify hot and cold spots through initial temperature mapping to determine optimal placement for permanent monitoring sensors.

2

Deploy Validated Sensors

Install high-precision wireless monitoring hardware that connects directly to our secure, cloud-based TrueCold data management portal.

3

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.

High-tech GDP compliant cold storage facility for pharmaceuticals

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.

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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?
Our platform is built from the ground up to support electronic signatures, detailed audit trails, and strict user permissions. This ensures that all data generated within your cold storage facility is authentic, reliable, and legally equivalent to paper records for regulatory review.
Is the monitoring system validated for GxP?
Yes, TrueCold provides a comprehensive validation package, including IQ/OQ/PQ documentation. This allows your quality team to verify that the system is operating exactly as intended within your specific GDP compliant cold storage environment.
What happens if the Wi-Fi or power fails?
Our hardware features local data logging capabilities. If a connection is lost, the sensors continue to record data internally and then automatically upload the missing timestamps once the connection is restored, ensuring no gaps in your compliance history.

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.