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Medical Devices

MES software for the Medical Devices industry

 

"The software has been developed to adhere to CFR21 Part 11 standards which is very important to us and to the industry as a whole."
Yann Deshayes, Quality Manager

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?

Shopfloor-Online MES / MOM is 21CFR Part11 compliant, enabling medical devices manufacturers to confidently move to paperless operations and manage all Device History Records electronically (eDHR). Adopting Shopfloor-Online MES/MOM 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 – injection moulding manufacturer

Supplier to the Medical Devices industry streamlines production with Shopfloor-Online:

  • MES modules for Tool Management and Quality guarantee consistent compliance to 21CFR Part 11 as well as providing accurate traceability and improved efficiency
  • Automated quality checks, production of Certificates of Analysis
  • Fast and reliable reporting

►Plastibell case study

 

"The software has been developed to adhere to CFR21 Part 11 standards which is very important to us and to the industry as a whole."
Yann Deshayes, Quality Manager