DHR (device history record)

The device history record is the evidence that a particular device, lot or batch was manufactured according to its device master record.

The historical US requirement, 21 CFR 820.184, asked for a device history record that included or referred to the dates of manufacture, the quantity manufactured, the quantity released, acceptance records, the primary identification label, and any device identification and control numbers used. ISO 13485 captures the same idea through batch records, traceability (clause 7.5.9 where applicable) and the control of records in clause 4.2.5.

An auditor compares the DHR with the DMR. If the DMR required an inspection and the DHR has no result, the lot is not fully evidenced, even if the product seems fine. Electronic DHRs need the same retention and signature controls as paper ones when you rely on them.

HAVGATE's audit, CAPA and document modules keep quality-system records. They are not presented as the production device history record for the factory floor. If a nonconformance starts from a batch record, cite the batch in the NCR so the two files still meet.