SOP-Operational-Qualification

TitleOperationalQualificationSOPVersionStatusDatePage1.0CommercialinConfidence16-Aug-20061of13OperationalQualificationSOPDocumentNo:SOP_0600Preparedby:DavidBrownDate:16-Aug-2006Version:1.0TitleOperationalQualificationSOPVersionStatusDatePage1.0CommercialinConfidence16-Aug-20062of13DocumentApprovalNameRoleDateSignatureDavidBrownAuthorDocumentControlVersionAuthorDateDescription1.0DavidBrown16-Aug-2006Firstdraft.TitleOperationalQualificationSOPVersionStatusDatePage1.0CommercialinConfidence16-Aug-20063of13TableofContents1Introduction....................................................................................................................................41.1Purpose......................................................................................................................................41.2Scope..........................................................................................................................................41.3Definitions..................................................................................................................................41.4References..................................................................................................................................51.5Responsibility............................................................................................................................52OperationalQualficationProcedure.............................................................................................63OperationalQualification-PhaseEntry/Exit...............................................................................83.1PhaseEntry...............................................................................................................................83.2PhaseExit..................................................................................................................................84OperationalQualificationProtocolContent.................................................................................94.1ProtocolTitle.............................................................................................................................94.2Pre-approval..............................................................................................................................94.3Objective/Scope.........................................................................................................................94.4SystemDescription.................................................................................................................104.5Testing......................................................................................................................................104.5.1TestPlans(forcomplexsystems).....................................................................................104.5.2TestCases.........................................................................................................................104.6AcceptanceCriteria................................................................................................................115OperationalQualificationReport................................................................................................125.1ReportonSystemTesting......................................................................................................125.2SummaryandConclusions....................................................................................................125.3ProtocolResultsAcceptance..................................................................................................12TitleOperationalQualificationSOPVersionStatusDatePage1.0CommercialinConfidence16-Aug-20064of131Introduction1.1PurposeThisSOPhastwopurposes;todescribetheOperationalQualificationprocessandalsothecontentsoftheOperationalQualificationProtocoldocument.TheOperationalQualificationprocessensuresthatavalidatedcomputersystem,‘thesystem’,operatesasdescribedinthefunctionalspecificationandmeetsthespecificrequirementsofthepharmaceuticalsindustryfor:Dataintegrity;Accesscontrol;Systemresilience,and;ElectronicSignatures.1.2ScopeDepartment/Section:Client,InformationTechnologyandValidationgroupsThisSOPappliestoallvalidatedcomputersystems.1.3DefinitionsSOP–StandardOperatingProcedure,adescriptionoftheprocessesandstandardsthatmustbeemployedtoundertakeaspecificsetofactivities.Validation–definedatitssimplest,isdemonstratingthatacomputersystemoperatesasitpurportsto,andthatitwillcontinuetodoso.Client–thebusinesssystemowneristypicallythe‘line’managerresponsibleforthebusinessprocesswherethecomputersystemwillbeused.ValidationGroup–thegroupresponsibleforensuringthatcomputersystemsareimplementedandmaintainedinavalidatedstate.ITGroup–thegroupresponsiblefordevelopment,operation,andmaintenanceofcomputersystems.TitleOperationalQualificationSOPVersionStatusDatePage1.0CommercialinConfidence16-Aug-20065of131.4ReferencesDocumentIDTitleSOP_0102DocumentStandards