Cell & Gene Therapy
Traceability in advanced therapies: from starting material to patient
Designing chain-of-identity, chain-of-custody, manufacturing, and evidence controls as one connected system.
For advanced therapies, traceability is not merely a logistics function. It protects patient safety, product identity, manufacturing control, data integrity, and regulatory credibility.
Define every handoff
Map collection, labeling, transport, receipt, processing, testing, release, distribution, administration, and disposition. Each transition needs an accountable owner, verified identity, time and condition records, and exception handling.
Connect physical and digital identity
Identifiers should remain consistent across manufacturing, laboratory, clinical, and logistics systems while protecting patient information and preventing manual transcription errors.
Design exception pathways
Temperature excursions, labeling discrepancies, delayed transport, incomplete records, and manufacturing deviations require predefined quarantine, investigation, escalation, and disposition controls.
Further regulatory context
Read medical device regulatory definitions and authoritative references. Explore the workflows eeRegOS supports.
Editorial note: This content is educational and does not constitute legal or regulatory advice. Product-specific decisions should be reviewed by qualified professionals using current authoritative sources.