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 ?What is therefore Computerized Systems Validation ?Why Computerized Systems Validation ?Reinhard E. Voglmaier ---Medical Department ---GSK Italy6 What is a Computerized system ?PeopleSoftwareHardwareComputer systemProcedures, Training, DocumentationNot only HW and SW, but also users, administrators, business processes, SOPs.
Reinhard E. Voglmaier --- Medical Department --- GSK Italy 13 Regulations ( description thx to Wikipedia ) Eudralex www.ema.europa.eu – EudraLex is the collection of rules and regulations governing medicinal products in the
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