Secure Your Annex 22 Compliant Cold Chain
Ensure total regulatory adherence with a monitoring solution designed for strict GXP pharmaceutical environments. Eliminate manual error risks and maintain product integrity across every stage of the lifecycle with validated audit trails and real-time intervention capabilities.
- Fully automated GAMP 5 category 4 software validation.
- NIST-traceable calibration with digital certificate storage.
- Proactive risk mitigation through predictive excursion alerts.
Request Validation Package
Book a technical walkthrough with our compliance team to review our protocols.
Defining an Annex 22 Compliant Cold Chain
An Annex 22 compliant cold chain represents the gold standard for pharmaceutical quality management. It requires rigorous, continuous monitoring of temperature-sensitive medicinal products to prevent degradation. Our platform automates the documentation and technical controls necessary to meet these specific regulatory hurdles, ensuring every batch remains within its validated thermal profile from manufacturing to the patient.
Audit Readiness
Maintain permanent access to tamper-proof data logs and electronic signatures, ensuring your facility is always prepared for sudden regulatory inspections or internal audits.
Risk Mitigation
Identify potential failures before they result in a product loss. Our predictive algorithms analyze trends to alert your QA team of impending excursions.
Full Traceability
Chain of custody reporting provides a complete visual map of every touchpoint, ensuring that accountability is maintained across the entire global distribution network.
The Compliance Playbook
A structured approach to implementing a robust monitoring framework.
Technical Mapping
Identify critical control points and perform thermal mapping of storage areas to define the optimal sensor placement for maximum visibility.
Validation Execution
Deploy NIST-calibrated hardware and execute IQ/OQ/PQ protocols to ensure the monitoring system functions as intended under load.
Continuous Oversight
Utilize real-time dashboards to oversee operations, responding instantly to deviations with documented corrective and preventive actions (CAPA).
Mastering Compliance with Real-Time Data
Achieving an Annex 22 compliant cold chain requires more than just high-quality refrigeration; it requires a digital twin of your physical environment. TrueCold provides the granular visibility needed to defend your quality decisions with hard data.
Our platform integrates directly into your existing Quality Management System (QMS), streamlining the release process and reducing the time required for excursion investigation from days to minutes.
Why Leading QA Teams Choose TrueCold
Zero Data Gaps
Hardware-level redundancy and internal memory storage ensure that even during network outages, every temperature point is recorded and synced.
Automated PDF Reports
Generate shipment and facility reports automatically upon arrival or at scheduled intervals, pre-populated with statistical analysis and excursion details.
Fast Deployment
Our wireless IoT sensors require no hardwiring or complex IT infrastructure, allowing you to bring new compliant lanes online in under 48 hours.
Compliance Questions
How does the system handle software validation?
TrueCold follows GAMP 5 Category 4 guidelines for software validation. We provide a comprehensive validation package including IQ/OQ/PQ protocols, risk assessments, and a traceability matrix, significantly reducing the burden on your internal quality teams during implementation.
Are the temperature sensors NIST-traceable?
Yes, all sensors utilized in our monitoring platform are NIST-traceable and come with individual calibration certificates. We manage the recalibration cycle automatically, notifying you well in advance of expiration to ensure continuous Annex 22 compliant cold chain operations.
Can the platform integrate with my existing ERP or QMS?
Our open API architecture allows for seamless data flow into major enterprise systems like SAP, Oracle, and Veeva. This enables automated product release workflows and ensures that temperature data is treated as an integral part of the batch record.
Ready to Automate Your Compliance?
Join global pharmaceutical leaders who trust TrueCold to protect their most sensitive products and maintain a flawless Annex 22 compliant cold chain. Let's build a more resilient supply chain together.