Case Study: Proteus achieves paperless, FDA‑compliant production and real‑time traceability with Parsec Automation's TrakSYS™

Complexities in Compliance made simple with Modular MES

Proteus Digital Health, maker of an ingestible sensor and wearable patch, faced rapidly growing, highly complex manufacturing that spanned wafer processing, sensor assembly, and tablet compression. Their production relied on a 35‑step paper Device History Record (DHR), manual data entry, poor traceability, and burdensome compliance tasks. To unify workflows and meet FDA requirements, Proteus selected Parsec Automation’s TrakSYS™ MES as their solution.

Parsec Automation configured TrakSYS™ to enforce manufacturing workflows, create electronic DHRs (eDHR), provide real‑time SPC and quality data, and integrate with instruments, barcode systems, label printers and operator workstations. The deployment eliminated paper eDHRs for wafer production, reduced data‑entry errors and labor, enabled real‑time visibility for faster problem resolution, and produced process metrics for better cost models—allowing Proteus’s team to assume ongoing MES ownership after Phase 1.

Proteus

Craig Mynatt

MES Project Lead