Transcription of Auditing GxP Critical Computerized Systems - AIEA
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Auditing GxP Critical Computerized Systems - AIEA
AuditingGxP CriticalComputerized Systems ISACA ItaliaFebruary, 17, 2010 Milano, ItalyReinhardE. Voglmaier---Medical Department ---GSK Italy2 ObjectivesUnderstanding the Validation ProcessHow to audit GxP Critical Computerized SystemsInspection ReadinessCan be used from two different point of views Auditor: how to prepare the audit Auditee: how to be prepared for the auditReinhardE. Voglmaier---Medical Department ---GSK Italy3 RoadmapIntroductionRegulations & GuidelinesGovernanceSystem InventoryPeopleSystem LifecycleChange ManagementIncident ManagementRisk ManagementSecuritySupplier ManagementInspection ReadinessQ&AIntroductionDefinitionsReinh ard E. Voglmaier ---Medical Department ---GSK Italy5 IntroductionWhat is a Computerized system ?
Auditing GxP Critical Computerized Systems ISACA Italia February, 17, 2010 Milano, Italy
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