Medical Devices

MES software solutions for the Medical Devices industry

 

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. 
 
  • Meet 21 CRF Part11 requirements with full traceabilty and eDHR.
  • Validate materials when used for example the material is the correct material in the Bill of Material (BOM)
  • Gain real-time visibility on operations and processes with visual tools and drill-down reporting
  • Improve efficiency across the board: fewer manual operations, accurate performance data such as OEE and man hours
  • Support continuous improvement with the Quality and CAPA modules of the Manufacturing Execution System
  • Go paperless – reduce cost of manual labour through eDHR paperless operations
  • Compliance & Risks – ensure fuil compliance to industry regulations and reduce risks with a system that enables full traceability of all devices via the eDHR
  • Streamline operations and decisions through real-time visibility -– the MES provides user specific reporting tools and shared information
  • Improve profit margins through greater efficiency and reduced spoilage
  • Support the IT strategy of your company with an information system seamlessly connecting plant equipment to plant operations, to business management.
  • Lower the risk of implementation – take a step-by-step approach to MES software and incrementally meet business needs with Shopfloor-Online modules.
  • Improve access and ease deployment – Shopfloor-Online is web-based, accessible anywhere on the network.
  • A global solution – Lighthouse Systems’ manufacturing operations management solutions are multi-site, multi-lingual, multi-time-zone.
  • Reduce the complexities of support and training with one MES addressing all operations needs.
  • Cloud based MES Software – move the servers to the corporate data centre or move to the cloud.
  • Lean IT – consolidate manufacturing operations with one scalable platform; remove home-grown applications and reduce the number of interfaces to various systems increasingly difficult to support.

Plastibell – Medical Devices

  • Improved management of injection moulding tools and cavities
  • Automated quality checks, production of certificates of analysis
  • Fast and reliable reporting
  • 21CFR Part11 compliance

►Plastibell case study