Life Sciences / Medical Device Manufacturing
Medical Device Industry Leader — First-Ever FTPS MES Implementation for Mass Spectrometry & Capillary Electrophoresis
An Unsolved Problem: FTPS Had Never Been Implemented for Medical Devices Before this engagement, no MES implementation had successfully deployed FTPS (Rockwell) functionality for the medical device i
Baseline → Fully audit-ready-Data
FDA Compliance Audit Readiness
70% → 99.5%
UDI Traceability Accuracy
Baseline → ~65%
Quality Management Risk Incidents
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