WIXLIB

AVEVA PI WORLDEnterprise Wide PI SystemPresented By: Andre Muller, Alister Geary 2021 AVEVA Group plc and its subsidiaries. All rights reserved.

DisclaimerThe information contained in this document belongs to Novartis and/or itsaffiliates. Novartis does not make and expressly disclaims: (a) any representationor warranty (express or implied) with respect to the information shown in thispresentation; and (b) any liability relating to the accuracy or completeness of theinformation.The views and opinions expressed in this presentation are those of the authorand do not necessarily reflect the official policy or position of Novartis or any ofits officers.2Business Use Only

Agenda1.2.3.4.Company Presentation: Andre Muller (3 min)Golden Image: Alister Geary (6 min)Global Architecture: Andre Muller (6 min)Integration workflows with other line of business systemsAndre Muller (6 min)5. Q&A3Business Use Only

Company Presentation 2021 AVEVA Group plc and its subsidiaries. All rights reserved.

We touch the lives of millions of people worldwide155 countries769m patients66m patientswhere Novartis products are soldreached in totalreached through access activitiesAll numbers are for continuing operations5Business Use Only

We are a focused medicines companyOur companyUSD 48.7bnNet salesUSD 8.1bnNet incomeAll numbers are for continuing operations6Business Use Only

Our strength is the diversity, energy and creativity of ourpeopleAll numbers are for continuing operations7Business Use Only110 738142HeadcountNationalities45.745%Annual training hoursper employeeWomen inmanagement

Golden Image 2021 AVEVA Group plc and its subsidiaries. All rights reserved.

PI System current footprintUSA:New JerseyIllinoisSan DiegoNorth HuningueSwitzerland:Basel Suzhou (x2)SuzhouSingapore:Singapore(x2)Golden Image (23 systems)Non-Golden Image (12 systems)

Deployment Challenges Novartis has 30 manufacturing and research sites aroundthe world. Deploying PI on a site by site basis raises challenges: Differing PI System Architectures and Windows Versions Different validation approaches for each site Local technical resource availability Missing IT pre-requisites often delayed implementation10Business Use Only

PI System Deployment via Golden Image ProcessObjective of Historian Golden image process was to create and qualify global master images that could bedeployed to site while inheriting all of the qualified configuration and validated functionality of the master image.PI System ArchitectureValidationMaster ImageDemand PlanningDeployment andLocalization11 Architecture, Software and OS Version aligned with IT ,Automation and OSIsoft as part of Enterprise AgreementCenter of Excellence. Create GMP validation plan to cover the Golden ImageProcess, for both master images and site deployments. Master images are built and validated against thearchitecture and validation plan in the global data center. The demand for new PI system deployments and upgradesis constantly reviewed and follows IT Project Managementstandards. A project team with IT and Automation members is formedfor each CreateMasterImagesIdentify SitesSiteDeployments Site A Site B Site N

Implementation Process Overview12HandoverEngineering / AutomationAMSApplication ManagementServices Incidents & ProblemsIT ChangesInfrastructure issuesSecurityBackup & Restore Local Validation ApproachTag AdditionsEquipment IntegrationRtReportsPI VisionAF configurationLocal/GlobalSite ProjectTeamIT OperationsIT DeliveryPI System Golden Imageimplementation

Life SciencesWorld-class upstream operationsChallengeSolutionBenefits Manage 30 PI Systemdeployments on sites locatedaround the world in a consistentand efficient way. Collaborate to create a standardized Reduction in PI System deploymentcost by 60% and time by over 50%.Golden Image process that can beused for a PI System on any site. Standardize Architecture, Versionand Validation across 30 Sites. Automation Reduces Errors Allow for creation of additionalGlobal Services across sites. 2021 AVEVA Group plc and its subsidiaries. All rights reserved.

Global PI System infrastructure 2021 AVEVA Group plc and its subsidiaries. All rights reserved.

ChallengesLocal infrastructurePI Vision: Multiple servers requested across 30 sites Site Network segregation according cyber security rules Different PI Vision version in the sites Standardization Developing from the scratch different views for same requirement How to bring the data from local to global PI system ?15Business Use Only

Business Functional DesignLocal and Global infrastructureGlobal InfrastructurePI VisionReal Time VizualisationStatus,GraphicalGlobalPI Visionviews, Trends etc.Business Intelligence ToolOAEEquipment, rejections, microstoppages, etcERPPI RTReportElectronic - Batch Report forEquipment- Data Integrity reviewReportTDV12NPI IntegratorGlobal PI SystemMESPI SysConnectorLocal PI SystemSmart DevicesIoT DevicesLocal Site (s) Infrastructure16Business Use Only

Global PI VisionInstantiation with PI Sys ConnectorQualificationGlobal PI Vision (D, Q, P)Global PI System (D, Q, P)AF/EFRootPI balNonGXPSQL InstallationQualification (IQ)of CollectionManager Once IQ per siteDA (P. S)Site ASite BPI RelayPI RelaySite CPI SysConnectorPI SysConnectorSite DPI AF DBLocal PI System (D, Q, P)Business Use Only17 Namingconvention InstallationQualification(IQ) once TagList

Life ScienceGlobal PI System infrastructureChallengeSolution Multiple servers requested across 30 Enable a Global PI System sitesarchitecture for the sites Site Network segregation accordingcyber security rules Different PI Vision version in the sites Standardization Developing from the scratch differentviews for same requirement How to bring the data from local toglobal PI system ? 2021 AVEVA Group plc and its subsidiaries. All rights reserved. Implementation of PI Sys ConnectorBenefits Reduces the number of local servers Efficient replication capability withthe global PI Vision Increased standardization sameviews for the same work centeracross sites Apply same qualification strategy Reduces the qualification steps(automatic tag update with PI sysconnector) No Tag list anymore onglobal level

Integration workflows withother line of business systems 2021 AVEVA Group plc and its subsidiaries. All rights reserved.

ChallengesIntegration workflows with other line of business systemsTransfer data from equipment specific for Cell and Gene, to PI historian Only MQTT Technology as Interface available from equipment vendorside Interface required between an Application on Linux and Aveva PIsystem on Windows20Business Use Only

Business Functional DesignLocal and Global infrastructureGlobal InfrastructurePI VisionReal Time VizualisationStatus, Graphicalviews, Trends etc.Business Intelligence ToolOAEEquipment, rejections, microstoppages, etcERPPI RTReportElectronic - Batch Report forEquipment- Data Integrity reviewReportTDV12NPI IntegratorGlobal PI SystemMESLocal PI SystemMQTTSmart DevicesIoT DevicesLocal Site (s) Infrastructure21Business Use Only

MQTT OverviewSoftware designPI System MQTT SparkplugconnectorPI System DA/AFPI System UFLconnectorMosquittoBrocker(Topics /Messages)Json FilesMQTT JSON Plug in22Business Use Only21mqttfx-1.7.1Simulator(Publish /subscribe)

Life SciencesIntegration workflows with other line of business systemsChallengeSolution Interface available fromequipment vendor side JSON Plugin used till new versionof PI MQTT connector released Linux and Windows compatible PI MQTT connector with read/writecapability and Json format as well,not only SparkplugBenefits Stay with vendor solution nocustomization required and keepthe adaption within Novartis Easy to implement JSON,Sparkplug Standard messaging protocol Enables it on a global level forfuture use cases 2021 AVEVA Group plc and its subsidiaries. All rights reserved.

ChallengesIntegration workflows with other line of business systems Replace manual data entries for test results fromequipment to ERP system with an automatedfunctionality Automated functionality for Cross domain file transfer Bi Directional communication24Business Use Only

CSV ToolSystems OverviewERPData VirtualizationPlatform25Business Use Only

ERPCSV Tool1Data Flow1: Data Virtualisation Platform publishes ORDER DATA in an URL2: PI UFL Connector reads JSON trough INI Configuration file and stores into PI Tag3: AF elements attributes are connected to PI Tags4: When a new value is detected, an analysis is triggered, which launches anotification subscribed to URL from Rest Application (CSV Tool)5: REST APPS generates a new CSV file which is saved on the shared folder fromthe equipmentData Virtualization PlatformDATAAccessServer1PI UFL Connector2PI System PI DAPI AFAttributes(Values)3API Node PI UFL ConnectorAnalysis / Eventframe (FileMaker)ISS Web Server1 CSV GEN REST APPS526Business Use OnlyNotification4PI WEB API

ERPCSV Tool5Data FlowData Virtualization Platform1: New Result File is created on the shared folder from the equipment2: PI UFL Connector reads INI Configuration file and stores into PI Tag3: AF elements attributes are connected to PI Tags4: When a new value is detected, an analysis is triggered, which launches anotification subscribed to URL from Rest Application (CSV Tool)5: REST APPS sends string result to Data Virtualization Platform system URLPI System PI DADATAAccessServerPI WEB API4PI AFAPI Node PI UFL Connector2INI Configuration1Business Use OnlyPI UFL Connector1 CSV GEN REST APPS3275Attributes(Values)Analysis / Eventframe (FileMaker)NotificationISS Web Server1 CSV GEN REST APPSPI WEB API

ERPCSV Tool8Data Flow1: New Result File is created on the shared folder from the equipment2: PI UFL Connector reads INI Configuration file and stores into PI Tag3: AF elements attributes are connected to PI Tags4: When a new value is detected, an analysis is triggered, which launches anotification subscribed to URL from Rest Application (CSV Tool)5:REST APPS query trough PI Web API function, all value between Start end EndTime, date are send to DA6: REST APPS writes into AF attributes a string with all data collected from DAassociated with Start and End Date a, time aggregated in the requested format7: Notification is subscribed to thePI System PI DAREST APPS URL8: REST APPS sends string result toData Virtualization Platform system URLAPI Node PI UFL Connector2INI Configuration128Business Use OnlyData Virtualization PlatformDATAAccessServerPI UFL Connector51 CSV GEN REST APPS5PI WEB API6PI AF3Attributes(Values)Attributes(Values)Analysis / Eventframe (FileAnalysis/ EventMaker)frame (FileMaker)4NotificationNotificationISS Web Server1 CSV GEN REST APPSPI WEB API7

Life SciencesIntegration workflows with other line of business systemsChallengeSolutionBenefits Replace manual data entries fortest results from equipment toERP system with an automatedfunctionality Automated Cross domain filetransfer Bi Directional communicationrequired Notification used Easy replication capability Limited qualification effort incase of adding values in themessage Enabler for future use case e.g.“Counter Based Maintenance” 2021 AVEVA Group plc and its subsidiaries. All rights reserved. Web API connector CSV GEN REST APPS

André MullerPrincipal Automation Engineer Novartis Andre.muller@novartis.comAlister GearyTechnical Design Expert Novartis Alister.geary@novartis.com 2021 AVEVA Group plc and its subsidiaries. All rights reserved.

2021 AVEVA Group plc and its subsidiaries. All rights reserved.