Inventory & traceability
Chain of Custody
coc tracking
TL;DR
An unbroken, documented record of who held, transferred, or modified a material/sample from origin to disposition.
Chain of Custody (CoC) records each transfer of physical possession of a regulated material, sample, or therapy (cell/gene, blood, controlled substance) with attribution, time, and condition. A break in CoC invalidates the material for its intended use.
V5 enforces CoC scans and e-signatures at every transfer point, so a missing handoff blocks downstream consumption and surfaces as a deviation.
Regulatory anchors
- 21 CFR 1271
- 21 CFR 1304
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.
Software that covers Chain of Custody
V5 Ultimate CGT Manufacturing Software
Autologous COI from apheresis to infusion, allogeneic lot genealogy from donor to bag, viral-vector eBR, ISBT 128 / SEC-178…
V5 Ultimate Tissue Bank Software
Donor eligibility as a hard gate, DRAI on the kiosk, ISBT 128 labelling, lookback as a single query, cGTP processing records, and…
Want to see Chain of Custody in V5?
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