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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 the regulation says
    Under FDA 21 CFR Part 820.70(i), automated processes, including Manufacturing Resource Planning (MRP) and Enterprise Resource Planning (ERP) systems, must be validated for their intended use. Similarly, ISO 13485:2016 clause 4.1.6 requires validation of computer software used in the quality management system. The EU MDR (Regulation (EU) 2017/745) Annex I, General Safety and Performance Requirements, also implicitly requires control over manufacturing processes, which includes the software systems managing them.

    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.

    Examples

    • A MedTech company implements a new ERP module for inventory management; this module must be validated to ensure accurate tracking of components, preventing use of expired or non-conforming materials.
    • During an FDA inspection, a manufacturer must provide documented evidence of the validation for their MRP system, demonstrating its ability to correctly manage the Bill of Materials and production orders.
    • An ERP system upgrade changes how lot numbers are assigned; the change control process mandates re-validation of this specific functionality to ensure continued compliance with traceability requirements.
    Common pitfalls
    • •A common pitfall is treating an ERP system solely as an IT tool, overlooking its critical role in controlling production and quality processes.
    • •Failing to involve quality assurance personnel in all stages of ERP system validation and change control can lead to non-compliant operations.
    • •Not adequately documenting the validation of each ERP module or configuration change can result in audit findings.
    • •Underestimating the impact of ERP system upgrades on existing validated processes and their associated risks is a frequent mistake.
    • •Over-reliance on vendor validation data without performing adequate in-house verification specific to the MedTech manufacturer's intended use is a significant oversight.

    Frequently asked questions

    The primary concern is ensuring that these systems, when used to control or monitor manufacturing processes and quality records, are validated to demonstrate they consistently produce accurate and reliable results, as required by regulations like FDA 21 CFR Part 820.70(i).
    Grouped by theme

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-06-20
    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

    Inline markers like [1] jump to the matching reference above.