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    ManufacturingManufacturing & SupplyMRP / ERP

    MRP and ERP Systems

    Material Requirements Planning and Enterprise Resource Planning systems that orchestrate MedTech production and supply chain.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    MRP/ERP systems connect demand forecasting, BOM explosion, supplier scheduling, inventory, lot/serial tracking, and quality holds. In regulated environments they require formal computer system validation.

    What this means in practice

    ERP changes (upgrades, configurations) are a frequent source of unexpected QMS impact - change control needs to include the ERP layer explicitly.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    ISPE·1FDA·1ISO·1
    1. 1
      GAMP 5
      Verified
      ISPEispe.org
    2. 2
      FDA - Device Manufacturing
      Verified
      FDAfda.gov
    3. 3
      ISO 13485 Standard Page
      Verified
      ISOiso.org

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