DHR software · 21 CFR 820.184 · per-serial
The Device History Record self-builds — per serial, as the device is built.
V5 Ultimate is DHR software that replaces the paper traveler with an electronic record bound to the unit's serial number. Operator signatures, torque values, in-process inspections, UDI label prints, deviations — all written live, locked at final inspection, ready for FDA inspection or 510(k) reference.
What DHR software means in practice
The record is right at sign-off — not after a 90-minute QA review.
Per-serial DHR, self-building
Every operator action writes the DHR for that serial number as the build happens. Locked at final inspection sign-off.
DMR-locked routings + tool-aware gating
Operators only see the current effective DMR rev. Calibrated torque tools push readings directly. Out-of-cal? Station locked.
UDI at the workstation
DI + PI assembled at the point of build, verified by camera, ready for GUDID and EUDAMED submission.
What you get the day DHR software goes live
Inspection-ready evidence, not month-end reconciliation.
- DHR 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 DHR; 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