The electronic Device History Record self-builds — per serial, as the device is built.
V5 Ultimate is eDHR software that replaces the paper traveler with an electronic record bound to the unit's serial number. Operator e-signatures, torque values, in-process inspections, UDI label prints, deviations — all written live under 21 CFR Part 11, locked at final inspection, ready for FDA inspection or 510(k) reference.
The record is right at sign-off — not after a 90-minute QA review.
Per-serial eDHR, self-building
Every operator action writes the electronic Device History Record for that serial as the build happens. Locked at final inspection sign-off — no end-of-batch reconstruction.
DMR-locked routings + tool-aware gating
Operators only see the current effective DMR revision. Calibrated torque tools push readings directly. Out-of-cal tool = station locked, not a deviation caught later.
UDI at the workstation
DI + PI assembled at the point of build, verified by camera, ready for GUDID and EUDAMED submission. Mis-label is a hard block, not a rework.
Inspection-ready evidence, not month-end reconciliation.
- eDHR review per unit collapses from 30–90 minutes to minutes
- 21 CFR 820.184 evidence is queryable by serial, lot, operator, or tool
- UDI label print is bound to the eDHR; mis-labelling is a hard block, not a deviation
- Calibration lapses lock the station, not the audit response
- The same record feeds 510(k) reference, MDR Tech File, ISO 13485 surveillance
- FDA QMSR (Feb 2026) transition is a configuration change, not a re-architecture