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    Process Validation

    Establishing documented evidence that a process consistently produces conforming output.

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

    Definition

    Process validation per GHTF/SG3 covers Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to demonstrate process capability for specifications that cannot be fully verified by subsequent inspection or test.

    What this means in practice

    Sterilization, injection molding, and software-controlled assembly are common validated processes.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    GHTF/IMDRF·1ISO·1FDA·1
    1. 1
      GHTF SG3 Process Validation Guidance
      Verified
      GHTF/IMDRFimdrf.org
    2. 2
      ISO 13485 Standard Page
      Verified
      ISOiso.org
    3. 3
      FDA - Device Manufacturing
      Verified
      FDAfda.gov

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