Medical Device Manufacturing Built for Compliance
FDA compliance shouldn't mean drowning in paperwork. WorkCell gives you electronic records, device history records, and full traceability without the manual overhead.
Compliance Built In
Not bolted on as an afterthought. Every feature designed with FDA requirements in mind.
FDA 21 CFR Part 11
Electronic records and signatures that meet FDA requirements. Audit trails, access controls, and data integrity built into the platform.
Device History Records
Automatic DHR generation as production happens. Every component, process step, and quality check documented without manual paperwork.
Lot Traceability
Full forward and backward traceability from raw materials to finished devices. Know exactly which lots went into which products.
Validation Support
IQ/OQ/PQ documentation packages and validation protocols. We help you through the validation process.
DHRs That Build
Themselves.
Stop assembling device history records from paper travelers, inspection sheets, and spreadsheets. As production happens, WorkCell captures every data point. When a lot ships, the DHR is ready.
Compliance Capabilities
Access Controls
Role-based permissions with electronic signatures
Full Traceability
Component-level tracking through production
Document Control
Revision-controlled procedures and work instructions
Quality Management
NCR handling, CAPA tracking, and inspection records
Training Records
Track operator certifications and qualifications
Risk Management
FMEA integration and risk-based controls
See FDA-Ready
Manufacturing Software.
Schedule a demo and see how WorkCell handles medical device manufacturing. Device history records, lot traceability, and 21 CFR Part 11 compliance.