Continued Process Verification (CPV) Automation Perkin .

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Continued Process Verification (CPV)AutomationPerkin Elmer 2016Data Analytics & R&D Informatics User ConferenceWilly RIBUSNov-3th 2016

1. Lifecycle Process Validation Model2. Continued Process Verification Programi.Multi generation Planii.Current statusiii.CPV Automation Phase 13. CPV Automation Phase 1 Demo session4. Next steps5. Q & AAgenda2

Lifecycle Process Validation Model3

1. Lifecycle Process Validation Model2. Continued Process Verification Programi.Multi generation Planii.Current statusiii.CPV Automation Phase 13. CPV Automation Phase 1 Demo session4. Next steps5. Q & AAgenda4

Continued Process Verification Program5

Paper batchrecordsLIMSDataAnalytical dataDataCollectionProcess dataDataCollectionSpecs,Control limits Reference DataRef datacollectionDataanalysisReportingLegend:Manual processAutomated processCPV Automation Phase 1 - Starting point6

Phase 1 - Manual Data Entry ysisReportingDataCollectionENTERPRISEDATA WAREHOUSEProcessdataPaper batchrecordsAnalytical &ProcessdataStatistical AnalysisTemplate SMTemplate LMTemplate FFPhase1 - Tibco-Spotfire User interfaceCPV Automation Phase 1 - ModulesOracleDBReferencedataRef dataMaintenancePhase 1- Reference Data module7

StartNEWCLONERENEWSelect & OpenexistingCPV analysisProductselectionAttribute SelectionVIEW2.Open existingCPV analysisSelect & OpenexistingCPV analysis3.Product, Period, Attribute& Parameter selectionPeriodExtensionNoIdentifyBatch qty perselected parameterBatchquantityOK?Yes4.Data LoadLoad data for eachselected parameterData analysisCPV Limits &Ppk indexesNoHighly sConsultstatisticianCPV Automation Phase 1 - Process Flow Investigate control chartsExclude data pointsInsert comments on alertsCalc. current CPV limits and PpkComparison with fixed CPV limits/ Ppk indexesExecutiveSummary Insert references to investigations Define if actions requiredReporting Generate temporary CPV report Review temporary CPV Report Generate final CPV reportReference dataManagementData Export5.Dataanalysis&Reporting Link to module to maintainreference data Data export capability for nonCPV applications8

Single sign-onLogin Define users’ roles EDW (Teradata)DataaccessSelectionprocess Ora DB Workflow selection Parameters selection Period selection Statistical analysisAutomatedanalysisUserInterface Automatic generation of visualizations, feeding Persistence Layer Interactivity HTML custom panels Showing / Hiding Visualizations Store metadataPersistenceLayer Store visualizations Use data from Persistence LayerReportGeneration Use Report Templates Re-use of analysis supported by different work flowsRe-useanalysis Retrieval meta data from persistence layerCPV Automation Phase 1 – Components9

1. Lifecycle Process Validation Model2. Continued Process Verification Programi.Multi generation Planii.Current statusiii.CPV Automation Phase 13. CPV Automation Phase 1 Demo session4. Next steps5. Q & AAgenda10

StartNEWCLONERENEWSelect & OpenexistingCPV analysisProductselectionAttribute SelectionVIEW2.Open existingCPV analysisSelect & OpenexistingCPV analysis3.Product, Period, Attribute& Parameter selectionPeriodExtensionNoIdentifyBatch qty perselected parameterBatchquantityOK?Yes4.Data LoadLoad data for eachselected parameterData analysisCPV Limits &Ppk indexesNoHighly sConsultstatisticianCPV Automation Phase 1 – Demo session Investigate control chartsExclude data pointsInsert comments on alertsCalc. current CPV limits and PpkComparison with fixed CPV limits/ Ppk indexesExecutiveSummary Insert references to investigations Define if actions requiredReporting Generate temporary CPV report Review temporary CPV Report Generate final CPV reportReference dataManagementData Export5.Dataanalysis&Reporting Link to module to maintainreference data Data export capability for nonCPV applications11

1. Lifecycle Process Validation Model2. Continued Process Verification Programi.Multi generation Planii.Current statusiii.CPV Automation Phase 13. CPV Automation Phase 1 Demo session4. Next steps5. Q & AAgenda12

1.CPV Automation Phase 2Auto retrieval of Process data for integration within CPV analysis2.CPV Automation Fine tune cycleImprove and Extend current CPV automation functionalityCPV automation - Next steps13

Phase 1 - Manual Data Entry SEDATA WAREHOUSEAnalytical &ProcessdataProcessdataPaper batchrecordsPhase 2 - PI IntegratorInterfacePI integrator forbusiness analyticsDataanalysisStatistical AnalysisTemplate SMTemplate LMTemplate FFPhase1 - Tibco-Spotfire User interfaceCPV Automation Phase 2OracleDBGlobalPI AF-EFPIHistorianAutomationLevel 1&2ReferencedataRef dataMaintenancePhase 1- Reference Data module14

Improve and Extend current CPV automation functionality based on User feedback during received during 1st usage of application Add additional functionality not covered during phase 1 (Park lot) Anticipate on new business requirements as specified in ongoing update ofglobal SOP / WICPV Automation Fine tune cycle15

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Template SM Template LM Template FF Analytical data Analytical & Process data Data . Workflow Selection 2. Open existing CPV analysis Start NEW RENEW RESUME VIEW Product Period . process Workflow selection P

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