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tem-165 design qualification protocol sample

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  • User Requirement

    Specification generated.

    QA review and approval of

    URS

    Supplier Audit.

    Confirm Functional

    Specification against URS

    Confirm other related

    Project Specifications .

    Design Review

    HAZOP

    Risk Assessment on

    Product Quality

    Impact Assessment for

    Computerised System.

    Refer

    FMEA

    Safety Audit

    Commissioning and

    Qualification Plan

    Factory Acceptance testing

    Site Acceptance testing

    Create Validation Plan


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