Precision medicine requires end-to-end traceability: everything from chain of custody, to chain of condition, to chain of identity. But the fragility of regenerative medicine therapies – and the need to more effectively manage risk– means that a fourth chain will soon be a requirement: the Chain of Compliance™.

The Chain of Compliance™ provides full traceability of the equipment and processes used in managing the environmental control of the commodity. Chain of Compliance™ requires a historical archive at the unit level, inclusive of the following elements:

• Equipment Performance History 
• Commodity History
• Equipment Requalification History
• Calibration History Data
• Correlation of In-Field Events to Shipper Performance

Cryoport's new White Paper on "The Regenerative Medicine Supply Chain: Anticipate New Compliance Standards Now or Risk Falling Behinds" explores the new supply chain regulations we can expect and how to address them with Chain of Compliance™. 

Click the button below to access the White Paper.