Results for “gamp-5”

Perform a 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 a new computerized system is being introduced in a GxP environment, when an existing validated system is undergoing significant change, when periodic revalidation is required, or when a regulatory inspection demands a validation gap analysis.

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Design a compliance architecture that maps applicable regulations to computerized systems. Covers system inventory, criticality classification (GxP-critical, GxP-supporting, non-GxP), GAMP 5 category assignment, regulatory requirements traceability, and governance structure definition. Use when establishing a new regulated facility, formalising compliance across multiple systems, addressing a regulatory gap analysis, harmonising compliance after mergers or reorganisations, or preparing a site master file that references computerized systems.

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