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9 Computer System Validation9 Computer SystemValidation99.A Introduction and terminology9.B Legal aspects9.B.19.B.29.B.39.B.49.B.5EuropeUSAPIC/SElectronic signatures and electronic recordsISPE GAMP® 5 – Good Au<strong>to</strong>mated Manufacturing Practice9.C System life cycle9.C.19.C.29.C.3The “V model”S<strong>of</strong>tware developmentConfiguration and cus<strong>to</strong>misation9.D System classification and risk management9.D.19.D.2System classification according <strong>to</strong> ISPE GAMP®5Risk management9.E Validation <strong>of</strong> computerised systems9.E.19.E.29.E.39.E.49.E.59.E.69.E.79.E.8Validation organisationValidation planSpecifications (user requirements/technical specification)Unit, integration, system and acceptance testsValidation reportData migration and start-upExamplesRetrospective validationGMP Manual (Up12) © Maas & Pei<strong>the</strong>r AG – GMP Publishing(1)
9 Computer System Validation99.F Operation <strong>of</strong> computerised systems9.F.19.F.29.F.39.F.49.F.59.F.69.F.79.F.89.F.9System descriptionUser trainingStandard operating procedures (SOPs)Access and securityData backup and archivingContingency plansChange management and error reportingPeriodic reviewRetirement <strong>of</strong> computerised systems9.G External service providers9.G.19.G.29.G.3Relocation <strong>of</strong> activitiesService level agreementAuditing <strong>of</strong> suppliers and service providers9.H References(2)GMP Manual (Up12) © Maas & Pei<strong>the</strong>r AG – GMP Publishing
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