perform-csv-assessment

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Perform Computer Systems Validation (CSV) assessment following GAMP 5 methodology. Covers user requirements, risk assessment, IQ/OQ/PQ planning, traceability matrix creation, and validation summary reporting. Use when new computerized system being introduced in GxP environment, when existing validated system undergoing significant change, when periodic revalidation required, or when regulatory inspection demands validation gap analysis.

By pjt222 schedule Updated 6/5/2026

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Install via CLI

npx skills add https://github.com/pjt222/agent-almanac --skill perform-csv-assessment

Repository Details

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Compliance Officers 131041