TrueCold | Platform Overview

This video provides an overview of the TrueCold platform, an agnostic data layer designed to unify and analyze cold chain logistics data for the pharmaceutical and life sciences industries. The primary purpose of the platform is to transform siloed IoT sensor data, logistics information, and internal system records (like ERP and QMS) into actionable, contextualized insights, thereby automating compliance checks, preventing costly deviations, and streamlining product release processes. The system functions in real-time, collecting data from various sources—including data loggers, telematics devices, and logistics partners—and integrating it with crucial stability data pulled directly from the client’s ERP and Quality Management Systems.

The platform is structured around several key modules designed for different operational roles. The main dashboard serves as a fully customizable central view, allowing users to generate various charts and graphs for simplified data reporting. A critical component is the tracking section, which monitors shipments, deliveries, and associated handling units. This module is responsible for triggering alerts based on predefined criteria, specifically "max exceeded," "min exceeded," and "mean exceeded" temperature thresholds. These alerts initiate a workflow, which the platform manages as a task list by allowing users to assign specific owners to address potential deviations immediately.

The core value proposition for quality assurance lies in the assessment module. This section is designed for quality personnel to evaluate the integrity of arrived product based on the collected data. The presenter illustrates a scenario where a product was rejected because the maximum temperature threshold was exceeded by nearly 5° C. This demonstrates the platform’s ability to provide the necessary validated audit trails and contextual data required for critical quality decisions. Furthermore, the platform emphasizes regulatory adherence, offering GDP/GMP-ready workflows and 21 CFR Part 11-validated audit trails, ensuring that the entire cold chain monitoring and release process meets stringent regulatory requirements. The system is designed to plug seamlessly into existing enterprise ecosystems, featuring pre-built integrations for major systems like SAP, Trackwise, and Veeva.

Key Takeaways: • Agnostic Data Layer for Cold Chain: TrueCold functions as a centralized, vendor-agnostic hub capable of aggregating data from any IoT provider, sensor, telematics device, or legacy system, resolving the common industry challenge of disconnected cold chain data. • Real-Time Data Unification: The platform combines real-time temperature, humidity, and GPS data from logistics sources with critical internal data, such as batch records and QC results, sourced directly from integrated ERP and QMS systems. • Automated Regulatory Compliance: The system supports GDP (Good Distribution Practice) and GMP (Good Manufacturing Practice) workflows, ensuring that all monitoring and release processes adhere to pharmaceutical quality standards. • 21 CFR Part 11 Validation: Compliance is heavily emphasized through the provision of 21 CFR Part 11-validated audit trails, which are essential for electronic records and signatures in regulated life sciences environments. • AI-Driven Contextual Insights: AI capabilities are utilized to correlate disparate data points (temperature, shipment metadata, batch records) to generate smart, contextualized insights, moving beyond simple data logging to true predictive analytics. • Proactive Risk Prevention: The platform offers real-time alerts and predictive analytics capabilities, enabling users to identify and fix potential risks before product integrity is compromised, thereby preventing costly product loss and delays. • Customizable Dashboarding: The main dashboard is fully customizable, allowing users to tailor charts and graphs to their specific reporting needs, simplifying the process of generating compliance reports and operational summaries. • Structured Deviation Management: Alerts are categorized into specific triggers (max exceeded, min exceeded, mean exceeded). The system formalizes the response process by treating these alerts as a task list, allowing for the assignment of owners and tracking of corrective actions. • Quality Assessment Workflow: A dedicated assessment module provides quality personnel with the necessary data and audit trails to make informed decisions regarding product usability upon arrival, as demonstrated by the example of rejecting a shipment where the max temperature was exceeded by 5° C. • Enterprise System Integration: The platform is designed for seamless integration with existing pharmaceutical enterprise software, including pre-built connectors for critical systems like SAP, Trackwise (often used for QMS/CAPA), and Veeva (a key CRM and content management platform in life sciences).

Tools/Resources Mentioned:

• TrueCold Platform: The core cold chain data management and analytics tool.
• Veeva: Mentioned as a system with pre-built integration, highlighting connectivity to pharmaceutical CRM and content management ecosystems.
• SAP: Mentioned as a system with pre-built integration, indicating connectivity to enterprise resource planning (ERP) systems.
• Trackwise: Mentioned as a system with pre-built integration, suggesting connectivity to quality management systems (QMS) and CAPA processes.
• IoT Providers/Data Loggers/Telematics Devices: Various sources for raw cold chain data integrated by the platform.

Key Concepts:

• Data Agnostic Layer: A system designed to integrate data from multiple, disparate sources (sensors, logistics providers, internal systems) without preference or reliance on a single vendor.
• 21 CFR Part 11: The FDA regulation governing electronic records and electronic signatures, requiring validated audit trails, which the platform explicitly supports.
• GDP/GMP: Good Distribution Practices and Good Manufacturing Practices, the quality standards governing the storage, handling, and distribution of pharmaceutical products.
• Cold Chain Monitoring: The process of ensuring temperature-sensitive products remain within acceptable temperature ranges throughout the entire supply chain journey, from manufacturing to patient delivery.