Medical Device Manufacturing Software
Medical device manufacturing software with FDA 21 CFR Part 11 compliance, lot traceability, device history records, and validation.
Sound Familiar?
DHRs Take Weeks to Assemble
Device History Records are scattered across spreadsheets, paper logs, and disconnected systems. When the FDA calls, pulling a complete audit package can take days. Every gap is a finding.
Traceability Breaks at the Supplier
End-to-end traceability from raw material to finished device is required under ISO 13485, but most manufacturers lose the thread the moment a component changes hands. One untraceable part can trigger a plant-wide recall.
CAPA Loops Stay Open Too Long
CAPA workflows running through email and manual logs have no enforcement. Nonconformances repeat, CAPAs age without closure, and regulators see a quality system that looks good on paper but never closes the loop.
Validation Overhead Slows Every Change
Any software touching production or quality data must be validated under ISO 13485. Running separate ERP, QMS, and shop floor tools means every update triggers a new validation cycle, consuming engineering time that should go toward product development.
How WorkCell Fits
Electronic DHR, Built into Production
WorkCell generates Device History Records automatically as jobs move through the shop floor. Every operation, inspection result, material lot, and electronic signature is captured in real time. When auditors arrive, no assembly is required.
Lot and Serial Traceability Across the Full BOM
WorkCell tracks every component from purchase order receipt through final shipment, fully satisfying ISO 13485 traceability requirements. A targeted recall takes minutes, not days.
Integrated CAPA and Nonconformance Management
Nonconformances raised on the shop floor automatically trigger CAPA workflows with assigned owners, due dates, and escalation rules. WorkCell gives ISO 13485 software auditors the documented closure evidence they look for.
Single Validated Platform
WorkCell is medical device manufacturing software that combines ERP, MES, and QMS in one system. Validate once, maintain one set of records, and eliminate the revalidation cascade triggered every time a point solution updates.
Compliance Coverage
Medical Device Manufacturing Software
See how medical device ERP built for audits keeps your DHRs, traceability, and CAPA evidence inspection-ready from day one.