Agilent OpenLAB: Managing Instruments, Content And Processes

Agilent OpenLAB:Managing Instruments,Content and ProcessesImproving Lab Efficiency andReducing InstrumentDowntimePharma/BioPharma IndustryMarketingChristoph Nickel,Software and Informatics MarketingSegment ManagerPharma/BioPharmaSpeaker TitleNovember, 5, 2007Page 1Group/Presentation TitleAgilent RestrictedMonth ##, 200X

ChallengesLaboratories are diverse environments Analytical raw data from all kind of instruments, often stand-alone Reports often on paperData GrowthGrowth in Number of Scientists Lots of data control in place Many procedures to followDataManagementGap Lots of regulations (GxP, 21 CFR Part 11, etc.)2000 2001 2002 2003 2004 2005 2006 Users need to be able to search and quickly find and retrieve the data,regardless of their storage location (online or in offline archive)Must get valuable information out of the diverse data quickly: Data should be stored on one central system Data should be comparable and available for review in one common form.Page 2Group/Presentation TitleAgilent RestrictedMonth ##, 200X

A solution - OpenLABOpenLAB – one modular system to manage the entire lab: Scientific Data Management for raw data and reports (centered around PDF) Chromatographic instrument management for 300 modules Advanced reporting Document Management Workflow automation Long-term data management and archiving Easy interfacing with all leading CDS systemsPage 3Group/Presentation TitleAgilent RestrictedMonth ##, 200X

OpenLAB: Modular Approach for SeamlessIntegration of CDS, ECM and BPMChromatography Data System(CDS)Enterprise Content Manager (ECM)with Workflow Automation (BPM)Redesigned from the ground up to work as onePage 4Group/Presentation TitleAgilent RestrictedMonth ##, 200X

Modular OpenLAB Configurations 1/3:Combining any CDS with OpenLAB ECMStandaloneCDS withstandaloneOpenLABECM –optional BPMand reporting;data uploadfor long-termdatamanagementin ECMPage 5Data go intoECMCDS System(any vendor )OpenLABEnterpriseContentManagementSystemOpenLAB BPM –WorkflowAutomationOpenLAB LIR –ReportingDatabaseGroup/Presentation TitleAgilent RestrictedMonth ##, 200X

Benefits of OpenLAB (ECM/BPM) with 3rd partyCDSEnabling paperless lab:– Long-term management (incl. archving) of all raw data in the lab– Traceable, revision controlled, electronic storage of reports linked toanalytical raw data– Integrated e-sig for all data and easy interoperability with otherapplicationsSimplifying and improving compliance:– All lab-related data in one repository (SOPs, analytical data, reports, )– Workflow automation for predictable and traceable execution of labproceduresImproving Lab efficiency:– Automation of review and approval for faster batch release– Single report format including grouping, sorting, advanced crosssequence calculations, easy data export for all analytical dataPage 6Group/Presentation TitleAgilent RestrictedMonth ##, 200X

Modular OpenLAB Configurations 2/3: TighterIntegration of ECM with Agilent CDSSpecific tools – Scheduler add-inor desktop integration - forseamless and user friendly bidirectional integration ofstandalone Agilent CDS withOpenLABAgilent CDSSystems:ChemStationfamilyChemStoreEZChromCDS IntegrationPage ementSystemSystemBPM – workflowAutomationLIR – DatabasereportingGroup/Presentation TitleAgilent RestrictedMonth ##, 200X

Modular OpenLAB Configurations 3/3: Fullyintegrated OpenLAB ECM and OpenLAB ICMFull OpenLAB system withInstrument Control, DataManagement and optionalBPM and reporting from asingle application with one nstrumentOpenLAB BPM –ControlWorkflowModule (ICM)AutomationOpenLAB LIR –ReportingDatabasePage 8Group/Presentation TitleAgilent RestrictedMonth ##, 200X

Benefits of fully integrated OpenLAB ApproachEnabling paperless lab:– Long-term management (incl. archving) of all raw data in the lab– Traceable, revision controlled, electronic storage of reports linked to analytical raw data– Integrated e-sig for all data and easy interoperability with other applicationsSimplifying and improving compliance:– All lab-related data in one repository (SOPs, analytical data, reports, )– Workflow automation for predictable and traceable execution of lab proceduresImproving Lab efficiency:– Automation of review and approval for faster batch release– Single report format including grouping, sorting, advanced cross-sequence calculations, easy dataexport for all analytical data– Automated review/approval of results and reportsPLUS Reduced costs for System maintenance and validation – one system only Training and User Education– one application for the entire labHigher Lab Uptime through: Automation of Instrument Maintenance and access control to OOM instrumentsPage 9Group/Presentation TitleAgilent RestrictedMonth ##, 200X

OpenLAB – functional OverviewInstrument ManagementNew!Content ManagementWorkflow automationLab Intelligence reportingPage 10Group/Presentation TitleAgilent RestrictedMonth ##, 200X

OpenLAB Instrument ManagementFull CDS functionalityplus Enterprise WideInstrument Organization Locations define the instrumenttopography Limit User access toinstrumentation through thehierarchy Instrument portal give highlevel view into instrumentscurrent activities Launch instrument controlwindow from the web portalControlDATAPage 11AICLaboratorynetworkGroup/Presentation TitleAgilent RestrictedMonth ##, 200X

OpenLAB – Content ManagementStore any recordConvert all reports into PDFfiles and extract meta datamaking data searchableView data without nativeapplicationPage 12Group/Presentation TitleAgilent RestrictedMonth ##, 200X

OpenLAB Business Process Management (BPM)Automate processes in thelaboratory without anyprogramming knowledgeDesign special “activities” intoa template that then runsautomatically using MS VisioExamples:Streamline the data reviewprocess for sample analysisreports including electronicsignoff.Automatically check if asample analysis reportshows impurities in a sampleand send an alert.Page 13Group/Presentation TitleAgilent RestrictedMonth ##, 200X

OpenLAB Business Process Manger – ExampleInstrument ready to useInstrument Maintenance9Maintenance reportInstrument in maintenance modeInstrument maintenance processAlert userMaintenance SOPPage 14PerformmaintenanceGroup/Presentation TitleAgilent RestrictedMonth ##, 200X

Overview: Instrument Maintenance ProcessThe first part of the demo shows the execution of the instrument maintenanceprocess in OpenLAB. The BPM is triggered and the instrument goes into maintenance mode. A user receives the maintenance task in their BPM Inbox, the SOP anda maintenance log are attached. The user carries out the maintenance task according to the SOP andfills out the maintenance log. The instrument is ready to use again. The maintenance log isaccessible from the OpenLAB Instrument Control tab.Page 15Group/Presentation TitleAgilent RestrictedMonth ##, 200X

OpenLAB Intelligence Reporter- a further step to the Paperless LabIncrease efficiency of data reviewby interactive reporting Fields to enter or select report parameterwithin the final report Button for displaying details within thefinal report.Instrument 2Instrument 3Faster decisions flag outliers by pass/fail criteria automatically sort results, etc.)Optimize workflows by integrationinto OpenLAB ECM Manage reports with BPM, e.g.automatic approval process Secure storage of reports, templates andqueries Revision controlPage 16Group/Presentation TitleAgilent RestrictedMonth ##, 200X

OpenLAB ArchitectureAIC Acquisition ControllerOpenLABDatabaseServiceOpenLAB umentsOpenLAB entsOpenLAB ClientsThird partyData systemsNetwork printersPage 17Group/Presentation TitleAgilent RestrictedMonth ##, 200X

OpenLAB Laboratory Software FrameworkCombination of CDS, ECM and BPM: Automate laboratory operations and workflows Manage laboratory desktop content (non-instrument) Manage and control instrumentation from different vendors Manage non-controlled instruments and other softwareapplications Advanced Reporting Interface to LIMS and ERP applicationsPage 18Group/Presentation TitleAgilent RestrictedMonth ##, 200X

Enterprise Content Management System Full OpenLAB system with Instrument Control, Data Management and optional BPM and reporting from a single application with one UI. Group/Presentation Title Agilent Restricted Page 9 Month ##, 200X Benefits of fully integrated OpenLAB Approach