Medical Device Manufacturing Software
Medical device manufacturing software with FDA 21 CFR Part 11 compliance, lot traceability, device history records, and validation.
Medical device manufacturers need software that combines ERP, MES, and quality into one validated system, so every device ships with a complete Device History Record and unbroken lot and serial traceability. WorkCell captures each operation, inspection, material lot, and electronic signature as production happens, then ties nonconformances into closed-loop CAPA. The result is a quality system that stays inspection-ready without spreadsheets, paper travelers, or disconnected point tools to reconcile before an audit.
Sound Familiar?
DHRs Take Weeks to Assemble
Device History Records are scattered across spreadsheets, paper travelers, and disconnected systems. When the FDA calls, pulling a complete audit package can take days of stitching records together by hand. Every gap between systems is a potential 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 at receiving. One untraceable lot can turn a contained issue into 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 past their due dates without closure, and regulators see a quality system that looks good on paper but never actually 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 another validation cycle, consuming engineering time that should go toward releasing product.
How WorkCell Fits
Electronic DHR, Built into Production
WorkCell builds Device History Records automatically as jobs move through the shop floor. Every operation, inspection result, consumed material lot, and electronic signature is captured in real time at the terminal. 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 lot-linked shipment, supporting ISO 13485 traceability requirements across multi-level versioned BOMs. A targeted recall scope takes minutes to determine, not days.
Integrated CAPA and Nonconformance Management
Nonconformances raised on the shop floor flow into an NCR severity matrix and 8-D CAPA workflows with assigned owners, due dates, and escalation. WorkCell produces the documented closure evidence ISO 13485 auditors look for.
AQL Inspections with Quality Holds
Define AQL sampling plans and inspection points along each routing, and place QC holds that block nonconforming lots from moving forward or shipping. Inspection results attach directly to the device record for full review-ready history.
Single Platform, Validate Once
WorkCell is medical device manufacturing software that combines ERP, MES, and QMS in one system. Validate one platform, maintain one set of records, and stop the revalidation cascade triggered every time a separate point solution updates.
Compliance Coverage
Explore Further
Quality Management System
AQL inspections, NCR severity matrix, and 8-D CAPA that produce the closed-loop evidence ISO 13485 audits require.
Quality Module
Inspection plans, QC holds, and nonconformance handling wired directly into production routings and the device record.
Pharmaceutical Manufacturing Software
Electronic batch records, full lot genealogy, and 21 CFR Part 11 support for regulated life-sciences production.
Common Questions
What software do medical device manufacturers need?
Medical device manufacturers need a system that unifies ERP, MES, and quality so production and compliance share one record. WorkCell delivers electronic Device History Records, full lot and serial traceability, AQL inspections with QC holds, and closed-loop CAPA in a single platform you validate once instead of validating several disconnected tools.
Does WorkCell support FDA 21 CFR Part 11 compliance?
WorkCell provides the features that support a Part 11 program: electronic signatures captured at the operation, time-stamped audit trails on quality and production records, and controlled access by role. WorkCell is not certified to any standard; you validate the system in your environment, and its records support your inspection-readiness.
How does WorkCell handle Device History Records?
DHRs are assembled automatically as work orders move through the floor. Each operation, inspection result, consumed material lot, and operator signature is captured in real time at the terminal and linked to the device unit. When an auditor requests a record, it is already complete rather than reconstructed from spreadsheets and paper.
Can WorkCell trace components from supplier to finished device?
Yes. WorkCell records lot and serial numbers from purchase order receipt, through every operation on multi-level BOMs, to the lot-linked shipment. Supplier metrics and PO history tie incoming material to its source, so determining recall scope or answering a complaint is a targeted query rather than a manual investigation.
Does WorkCell include CAPA and nonconformance management?
Yes. Nonconformances raised on the floor route through an NCR severity matrix into 8-D CAPA workflows with assigned owners, due dates, and escalation rules. The system enforces closure and retains the evidence trail, giving ISO 13485 auditors the documented loop closure they expect to see.
Why use one platform instead of separate ERP, MES, and QMS tools?
Under ISO 13485, every system touching production or quality data must be validated, so each separate tool multiplies validation work and creates integration gaps that become audit findings. WorkCell combines ERP, MES, and quality in one platform, so you validate once and keep a single connected set of records.
Medical Device Manufacturing Software
See how medical device ERP built for audits keeps your DHRs, traceability, and CAPA evidence inspection-ready from day one.