Inventory & traceability
Chain of Identity
Chain of Identity · coi
TL;DR
The unbroken identity link between a patient and their autologous cell therapy from apheresis collection to infusion — distinct from Chain of Custody.
Chain of Identity (CoI) is the identity link in autologous cell and gene therapy: patient identifiers carried with the product and verified at every transfer so that the patient receives exactly their own engineered cells. CoI complements Chain of Custody (which proves possession) and is required by FDA CGT guidance and emerging ISBT standards.
V5 enforces CoI scans at apheresis, manufacturing release, shipment, and infusion — any mismatch hard-blocks the next step.
Regulatory anchors
- 21 CFR 1271
- FDA CGT Guidance
- ISBT 128
Industries that live with this
How V5 handles it
eBMR / eDHR — the batch record writes itself.
When the master is locked and the operator works on the kiosk, the batch record is no longer something to assemble — it’s something to render.
21 CFR Part 11 — the operating model, not a checkbox.
Other systems bolt Part 11 on top. V5 enforces it at the database layer so application code can never rewrite history.
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