Chain of Compliance®

Precision and Reliability with Chain of Compliance® from Cryoport Systems

Ensuring Quality and Compliance for Temperature-Controlled Supply Chains

Unlike conventional logistics solutions, Cryoport Systems offers unparalleled traceability, ensuring the integrity and custody of critical materials throughout their journey. Our Chain of Compliance® integrates validated requalification procedures, segregates human- and animal-derived products, and maintains a complete history of equipment performance and location. By leveraging extensive data collection and management capabilities, we mitigate risks and implement preventative measures to ensure the safe delivery of invaluable materials.

  • End-to-End Traceability: Monitor every step of the supply chain to ensure compliance and product integrity.
  • Chain of Condition: Track and maintain environmental controls to preserve the condition of sensitive materials.
  • Chain of Identity: Safeguard the identity of each product, ensuring it reaches the right destination without compromise.
  • Validated Requalification Procedures: Ensure all equipment meets rigorous standards before each use.
  • Data-Driven Risk Mitigation: Utilize robust data management to anticipate and prevent potential issues.

Chain of Compliance® Delivers Unmatched Precision in Monitoring and Managing Every Aspect of the Supply Chain

Equipment Performance

Ensuring the optimal functionality of all equipment used in the supply chain is critical to maintaining the integrity and safety of sensitive materials. Cryoport Systems’ Chain of Compliance® provides a robust system for monitoring and recording equipment performance, enabling proactive maintenance and reliability.

  • Detailed Performance Logs: Track critical metrics such as nitrogen evaporation rates, vacuum integrity, and hold times to ensure equipment operates within specified parameters.
  • Maintenance and Requalification Records: Maintain comprehensive records of all maintenance activities and requalifications, providing a clear history of equipment performance.
  • Predictive Analytics: Use data-driven insights to anticipate and address potential equipment failures before they impact the supply chain

Commodity, Transportation, Performance, and Deviation History

Cryoport’s Chain of Compliance® ensures the secure and compliant transportation of sensitive materials by maintaining a detailed history of each shipping system that includes commodity types, transportation, performance and deviation history throughout the supply chain.

  • Comprehensive Commodity Logs: Track and document the transportation history of each shipping system, ensuring compliance with industry standards and regulations.
  • Deviation Tracking: Monitor and record any deviations from standard operating procedures to quickly identify and rectify issues, ensuring the safety and integrity of transported materials.
  • Segregation Assurance: Ensure strict segregation of human- and animal-derived products, preventing cross-contamination and maintaining regulatory compliance.

Equipment Requalification

Regular requalification of equipment is essential to ensure it meets the stringent standards required for transporting sensitive materials. Cryoport Systems’ Chain of Compliance® includes rigorous requalification procedures to validate equipment before use, making Cryoport Systems the only provider to requalify every shipper, every time. Additionally, every shipping system undergoes Veri-Clean®, the industry’s first and only validated cleaning and disinfection process, before every shipment.

  • Routine Requalification Tests: Conduct regular tests to verify that equipment meets all necessary standards and is fit for use in the supply chain.
  • Detailed Documentation: Keep precise records of all requalification procedures and their outcomes, ensuring transparency and accountability.
  • Preventative Measures: Address potential issues identified during requalification to prevent equipment failures and ensure continuous compliance.

Calibration and Maintenance History

Accurate and reliable monitoring devices are crucial for maintaining the integrity of the supply chain. Cryoport Systems’ Chain of Compliance® ensures that all equipment undergoes regular calibration and maintenance, providing a detailed history of these activities.

  • Accurate Calibration Records: Ensure all data loggers and monitoring devices operate within specified parameters through regular calibration checks.
  • Routine Maintenance Logs: Maintain comprehensive records of all maintenance activities, ensuring equipment remains in optimal condition.
  • Compliance Assurance: Adhere to industry standards for equipment calibration and maintenance, ensuring the reliability and accuracy of data collected.

Correlation of In-Field Events

Linking real-time in-field events with equipment performance is essential for maintaining supply chain reliability and compliance. Cryoport Systems’ Chain of Compliance® enables this correlation, providing actionable insights to enhance operational efficiency.

  • Real-Time Event Monitoring: Track and record in-field events such as temperature fluctuations, shock events, and other environmental factors that could impact equipment performance.
  • Data Correlation and Analysis: Analyze the relationship between in-field events and equipment performance to identify trends and potential issues.
  • Continuous Improvement: Use insights gained from in-field event correlation to implement improvements in equipment design, maintenance, and operational protocols, ensuring ongoing reliability and compliance.

Cryoport’s Chain of Compliance® Sets the Standard for Compliance and Traceability in Supply Chain Management

White paper

Precision in Every Step

Comprehensive Monitoring and Data Management

Cryoport Systems’ Chain of Compliance® is a comprehensive, integrated solution providing transparency and control over the entire temperature-controlled supply chain. By leveraging advanced data analytics and real-time monitoring, we ensure that every shipment meets the highest standards of quality and safety. Our approach addresses key compliance aspects, including equipment performance history, commodity history, requalification history, calibration data, and the correlation of in-field events to equipment performance.

By adopting our Chain of Compliance®, companies can focus on their core mission of developing life-saving therapies, confident in the security and integrity of their supply chain.

Read the Chain of Compliance White Paper