Traceability along the supply chain is critical in the medical industry because it helps ensure the safety and quality of medical products and devices. Various regulations and agencies issue standards that require compliance, including the Food and Drug Administration (FDA) in the U.S., the Medical Device Regulation in the European Union (EUMDR), good manufacturing practices (GMP) and more.
In our efforts to continually improve product quality, increase production transparency, and help our clients remain compliant with industry standards, CO-AX Technology Inc. has just implemented Aegis FactoryLogix software for medical traceability.
This integrated suite of software modules helps lend speed, control, and greater visibility to manufacturing operations. The specific software package CO-AX purchased is designed to facilitate FDA-compliant medical traceability.
One key for traceability is material assurance. Should an isolated defect occur, traceability analysis can pinpoint the circumstances that led to this defect and supply corrective measures or actions to prevent a repeat occurrence.
Overall, this new Manufacturing Execution System (MES) platform aids with material, product, and process traceability. Robust data capture will enable us to supply our medical customers with improved product quality and enable precise tracking and control.
