Medical Device Manufacturing ERP for Lot Traceability and Compliance
Maintain full lot genealogy from raw material to device serial, capture controlled QC evidence with sign-off, and produce audit-ready batch records on demand. Built for medical device and precision engineering manufacturers.
- Full lot genealogy
- Audit-ready batch records
- Controlled QC with sign-off
- Mandatory QC hold points
- Deviation & disposition control
- Quick audit retrieval
Production flow
Full lot genealogy required from every raw material batch to every finished device
QC documentation must be retained, structured, and auditable on demand
Process deviations have to be recorded with a disposition, not just noted
Full QC documentation with inspector sign-off and parameter recording
Lot genealogy linking raw material batches to finished device serials
Controlled process routing with mandatory QC hold points
Quality trending and rejection analysis for process improvement
What each role gets out of Fleek
From the floor to the boardroom, everyone sees the part of the factory they own.
Production Manager
- Controlled routing status by stage
- QC hold-point clearance visibility
- Operator accountability on every lot
Quality Manager
- Deviation and disposition control
- Complete QC documentation
- Batch release readiness
Regulatory & Audit Lead
- Audit-ready records on demand
- Full traceability coverage
- Retained, structured quality history
Managing Director
- Lower audit and compliance risk
- Reduced scrap and rejection cost
- Faster batch release and dispatch
Why Medical manufacturers choose Fleek ERP
See how Fleek fits Medical production. We demo against your actual flow, not a generic factory.