Process optimization in MedTech manufacturing: MES solutions as the key to compliance and paperless production

  • Adapting to rapid industry changes with MES/MOM solutions that meet evolving regulatory needs (ISO standard 13485, FDA cGMP, 21 CFR Part 11 and 820)
  • Full transparency and control of the production process in real time
  • Active traceability: batch and serial number tracking across all production stages (end-to-end with a digital Poka Yoke approach)
  • Prevention strategies through setup verification (no use of incorrect, defective or blocked components)
  • Non-conformance management support for process quality engineers and quality assurance
  • Seamless ERP/SAP integration

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