The Value of the Novartis EA for San Carlos Site and Novartis Achievements/Goals of the Global PI System Strategy

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The Value of the Novartis EA for San Carlos Site and Novartis Achievements/Goals of the Global PI System Strategy Presented by Serge de Grandpre (Novartis) and Vito Ruggieri (OSIsoft) USERS CONFERENCE 2017 @osisoft #OSIsoftUC Copyright 2017 OSIsoft, LLC

Technical Operations OSIsoft User Conference presentation Serge de Grandpre (Novartis) and Vito Ruggieri (OSIsoft) San Francisco March 22, 2017

Agenda 1. Overview of Novartis and San Carlos Site 2. Enterprise Agreement with OSIsoft 3. Three Novartis Global PI System accomplishments 4. Two San Carlos Challenges that were met with the PI System 5. Future Plans 6. Summary 3

Disclaimer "The information contained in this presentation belongs or has been licensed to Novartis and/or its affiliates. Novartis does not make and expressly disclaims: (a) any representation or warranty (express or implied) with respect to the information shown in this presentation; and (b) any liability relating to the accuracy, fitness for any purpose or completeness of the information. The views and opinions expressed in this presentation are those of the author and do not necessarily reflect the official policy or position of Novartis or any of its officers. 4

Novartis overview Global Pharmaceutical Company, Headquartered in Switzerland 2016 Net Sales: 48 billion USD, ~118,000 Associates Portfolio: Innovative Medicines (small and large molecules), Generics, Eye Care NTO: 67 Mfg Sites in 27 countries 5

San Carlos site overview Small strategic site focusing on pulmonary diseases Main product: TOBI Podhaler Manufacturing process: spray drying and filling; with clean rooms and clean utilities Spray Dryer Powder (PulmoSphere TM ) Filled Capsule Marketed Product 6

Novartis journey to OSIsoft EA The value of OSIsoft Partnership for NOVARTIS over time: Strong need to leverage on edge technology and trustable partners to accomplish the High Quality Manufacturing required in Pharma Novartis recognized OSIsoft from the very beginning, as reference company/product for their stringent requirements Since 1999 the PI System has been used in Novartis and gradually the PI System has replaced all legacy Historians In 2013 the Enterprise Agreement with OSIsoft was signed Since the sign-off date many new sites joined the EA The journey towards the PI System as Event / Data Infrastructure fully in place NOW!! 7

OSIsoft Services approach Supporting Strategic Accounts as NOVARTIS is Utilize industry business acumen and a deep understanding of customers Environment, People and Business Objectives to deploy services that impact business results Integrate Services with Product Roadmap Align with Product Management to ensure an integrated product/ service launch which incorporates voice of the customer feedback Seamless Customer Journey Developed an agile services team that provides NOVARTIS with a consistent experience from co-authoring of business goals through delivery to drive adoption maturity Envisioning Potential Internal competency that can discover and position the possibilities of applying the PI System 8

Novartis + OSIsoft Services = Results AM EPM CoE FSE OSIsoft NOVARTIS Project Manager Infrastructure EA Services Global PI Team End Users Client Tools PI Admin SME(s) Service Plan & Architecture Data Infrastructure Process Change Advanced Services Stake- Holders Business Transformation Executive Sponsors Vision NOVARTIS & OSIsoft Services Working Together to Achieve Valuable PI System Data Infrastructure Adoption 9

Some OSIsoft methodological tools in Novartis EA 1. EA Roadmap It is to outline the activities, schedule, process and deliverables to be provided by OSIsoft s EA Services as part of the Enterprise Agreement. It is to serve as a guideline and roadmap for implementing these objectives successfully while focusing on maximizing NOVARTIS return on their Enterprise Agreement investment. 2. Business Impact Workshops A flexible framework to determine key business areas and the associated value that can be realized with the PI System as an enterprise data infrastructure and the adoption of new operational or business processes. 3. Educational Workshops Designed to create first level of PI System awareness at user level. Then, presenting specifc examples of Novartis business processes managed by the PI System. 10

Novartis EA major achievements 1. Roll-out and Training Programs 2. Standardization 3. Global AF Model 4. CPV and PAT 5. IT-OT Integration 6. MES Integration 7. DCS Integration 8. Supporting Site-Specific Projects 11

DCS integration: Embedded PI Server Embedded PI Servers installed in three DCS Easier to manage because they are consistent with other PI servers Plant staff use the embedded PI Server for monitoring & troubleshooting Office staff use the site PI System for reports (PI to PI interface) 12

MES Integration: PI System as a Data Bus Handshaking between MES & PI System and between PI System & standard SCADA validated globally once Templates can be re-used by sites to interface with similar equipment Helps speed up integration of new machines 13

IT-OT integration: Proof of concept for Equipment Efficiency Metric System PI Integrator for Business Analytics used to connect to BI data visualization software With BI software, data can be sliced and diced to find root causes of machine stoppages 14

San Carlos PI System use cases introduction Upgraded the PI System in 2014 according to the global standardization process defined at HQ San Carlos attends regular global PI System meetings, and communicates with other sites and with OSIsoft Two recent challenges that were met with the PI System are described next: 1. Monitoring of Stability Chambers 2. Multi-Batch Trend Report 15

San Carlos PI System PI Server Collective PI AF and Analytics Managed PI ~12 OPC interface nodes ~10,000 tags GMP compliant (with sandbox dev. env. - all virtual machines) 16

Challenge #1: Monitoring of stability chambers Need to monitor Temperature and RH of new Stability Chambers Stab. Chamb. are used to test and store products in specific temperature and/or humidity conditions Two options considered are described in next slide 17

Solution architecture 18

Technical solution: Asset Analytics for Notifications and Event Frames 19

PI ProcessBook and PI Coresight displays 20

Alarm Report with PI OLEDB Enterprise and SSRS 21

Solution benefits All logic and data is in the PI System No need to create SCADA graphics No need for additional SCADA licenses PI OLEDB Enterprise included in EA 22

Challenge #2: Process parameter multi-batch trending/monitoring Need to automate periodic CPV report that takes too long Old process: 1. Query SQL database to find start and end time of each batch & subbatch 2. Query PI Server with PI DataLink for raw data for each batch & subbatch and calculate aggregate values and create charts New process: 1. Select Batch ID s, click View Report. 23

Process parameter multi-batch trend report 24

Technical solution: new PI tags, EF, PI OLEDB Enterprise & SSRS 1. 1-min average PE tags to ensure all sub-batch have same amount of data points 2. Event Frames w/ attributes for aggregate data: avg, min, max, standard deviation (built-in calculations) 3. Query AF database via PI OLEDB Enterprise and returns result in SSRS report 25

Solution benefits Validated PDF report saves approx. 150 man-hour/year Easy to export csv data into statistical tool for further analysis Due to rectangular dataset made up of 1 min. avg data points 26

Future Plans San Carlos: Create more reports via PI OLEDB Enterprise and SSRS Upgrade PI Coresight to be able to acknowledge Event Frames Global: Silent Install of PI System Global AF Model Alarm Notifications PAT and OPC UA Keep working on projects previously mentionned 27

The Value of the Novartis EA for San Carlos Site and Novartis Achievements/Goals of the Global PI System Strategy COMPANY and GOAL Novartis is a major global pharmaceutical company and wants fully leveraging its Enterprise Agreement (EA) with OSIsoft Company Logo Picture / Image CHALLENGE Novartis wants to leverage the EA to meet various business challenges SOLUTION Prototypes and various projects executed with OSIsoft support RESULTS Increase productivity and compliance MES and DCS integration, OT BI visualization Equipment monitoring, Reporting Leveraged EA for downloads, installations, support/escalation Lower cost of integrating equipment Single version of the truth for monitoring, alarming, reporting One example saves 150 man-hr/yr USERS CONFERENCE 2017 @osisoft #OSIsoftUC Copyright 2017 OSIsoft, LLC

Contact Information Serge de Grandpre Serge.de_grandpre@novartis.com Staff Engineer, Automation&Controls Novartis Vito Ruggieri vruggieri@osisoft.com Enterprise Program Manager OSIsoft USERS CONFERENCE 2017 @osisoft #OSIsoftUC Copyright 2017 OSIsoft, LLC 29

Questions Please wait for the microphone before asking your questions Please remember to Complete the Online Survey for this session State your name & company http://bit.ly/uc2017-app USERS CONFERENCE 2017 @ osisoft #OSIsoftUC Copyright 2017 OSIsoft, LLC 30

Thank You USERS CONFERENCE 2017 @osisoft #OSIsoftUC Copyright 2017 OSIsoft, LLC 31