Meet key challenges including quality, traceability and compliance
Medical devices are a category covering anything from blood sample and drug dosage containers to syringes, surgical gloves and heart valves. It is a fragmented industry sector with many companies working in specialist, niche markets, yet they all have factors in common.
These add up to a range of challenges:
The industry is heavily regulated, imposing some very strict compliance obligations on manufacturers, in particular with respect to electronic Device History Records (eDHR)
A need for rigorous quality control, products traceability and enforcement of the Food and Drug Administration’s (FDA) 21CFR Part11
The need to reduce costs whilst satisfying compliance and quality obligations
How can Lighthouse Systems MES help you?
Lighthouse Systems’ Shopfloor-Online MES is 21CFR Part11 compliant, enabling medical devices manufacturers to confidently move to paperless operations and manage all Device History Records electronically (eDHR). Adopting Lighthouse Systems’ MES brings real-time visibility into production as well as quality operations required to reduce manual operations, support OEE improvements and first-time pass rate.