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.
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