Medical devices

A quality management system for medical devices and regulated industries — inspection plans, deviations and CAPA, electronic batch records and audit traceability to support compliant delivery.

An MES-centric production execution system — batch/serial traceability, process collection, quality closure and equipment connectivity, integrated with ERP/PLM and deployable on-prem as needed.

Batch records: merging three data sources into one batch

Batch data sat in DCS, paper records and spreadsheets; audits required manual reassembly. Critical parameters were transcribed by hand — transcription itself is a risk. Deviations had no single workflow from report to closure, so root causes got lost, and SOP versions drifted on the shop floor.