Device manufacturing records, DHR/DMR documentation and QMS evidence require consistent review of signatures, required fields, deviations and SOP alignment. Biolevate supports first-pass QC with source-linked issue detection and reviewer traceability.
Faster DHR/DMR review
Accelerate first-pass QC of DHR, DMR and manufacturing records by checking completeness, signatures, required evidence and SOP alignment.
Earlier deviation detection
Flag missing records, traceability gaps, process deviations, out-of-spec results and incomplete release evidence before quality review.
Traceable device release rationale
Link every check, issue and reviewer decision to source records, specifications, SOPs, risk controls and manufacturing evidence.
How it works
1
Ingest DHR/DMR evidence — collect manufacturing records, device master records, specifications, SOPs, inspection results and release documents.
2
Define QC checks — map required fields, signatures, process steps, traceability evidence, risk controls and acceptance criteria.
3
Run first-pass review — flag missing evidence, deviations, inconsistencies and release documentation gaps.
4
Generate the issue log — produce source-linked findings and reviewer decisions for QA and QMS validation.
Device-record QC logic: review DHR/DMR content against manufacturing requirements, traceability needs, risk controls and release criteria.
Inspection-ready run record: every finding and decision is logged for QMS review, CAPA follow-up and notified-body readiness.