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Skills with input: GxP regulatory context

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  • perform-csv-assessment - Perform CSV Assessment with GAMP 5 Methodology
    csvgamp-5validationrisk-assessment

    ★ 34 · Updated 2026-06-30

    Perform Computer Systems Validation assessment following GAMP 5 methodology covering URS, risk assessment, IQ/OQ/PQ, traceability, and validation reporting.

    ⚙ Determine GAMP 5 software category⚙ Write User Requirements Specification⚙ Perform FMEA risk assessment