MES Middle Ages Evolution Space. Florian Seitz Werum Asia Support Centre

MES From Past to Present to Future 1 MES Middle Ages Evolution Space Florian Seitz Werum Asia Support Centre MES From Past to Present to Future 2

From Past to Present to Future Nokia 5100 iphone 5 15 years 1998 2013 MES From Past to Present to Future 3 From Past to Present to Future Nokia 5100 iphone 5 14 years 1987 2012 MES From Past to Present to Future 4

What is MES? MES stands for Manufacturing Execution System. Specify, execute and document all pharmaceutical production operations. The main purpose is to minimize production and documentation errors, optimize the manufacturing processes and increase efficiency. An MES needs to ensure compliance with regulations (e.g. cgxp of the FDA, GMP of the EU, PIC/S). MES From Past to Present to Future 5 MES From Past to Present to Future Introduction Werum MES concept MES overview A modular approach MES benefits Past Present Future scenarios MES From Past to Present to Future 6

Werum at a Glance 480+ employees Founded 1969 Constant growth Strong financials Werum AG, Headquarters, Lueneburg, Germany Best-in-class MES product for Pharma & Biotech Werum America Inc., Headquarters, Parsippany, NJ, USA Professional services Customer satisfaction & long term partnerships MES From Past to Present to Future 7 Your Leading MIT Partner for Life Sciences Werum US HQ Parsippany, NJ Werum Germany HQ, Lueneburg St. Augustin Hausach Basel S. Francisco, CA Cary, NC Werum SAS Toulouse, France Werum K.K. Tokyo, Japan Werum Ltd. Asia Support Centre Singapore, Subsidiary Bangkok MES From Past to Present to Future 8

Werum & PAS-X Success Stories 380 400 450 470 490 Employees Stable Growth per Year h + 15 % 2009 2010 2011 2012 2013(e.) Pharma 50% Biotech and API 40% Others 10% Revenue by Industry Revenue by Region USA 45% Europe 45% Asia Pacific 10% MES From Past to Present to Future 9 International Key Customers in Asia/Pacific MES From Past to Present to Future 10

MES From Past to Present to Future Introduction Werum MES concept MES overview A modular approach MES benefits Past Present Future scenarios MES From Past to Present to Future 11 Producing Paper & Pharmaceuticals... Looks familiar? Manufacturing pharmaceutical products and flooding yourself in paper documents? MES From Past to Present to Future 12

Where do we come from? ERP MES Equipment MES From Past to Present to Future 13 Key Pain Points in Pharma Manufacturing Manufacturing execution, batch record and batch release Paper batch records Manual, error prone (humans) and time consuming Hundreds of manual entries for every paper batch record Non-readable / wrong / uncompleted entries No sequence and completeness control of work instructions Resulting in long review and release times Operator spends more time on batch record and equipment logs as on manufacturing procedures Equipment and material Difficult tracking, locating and cycle counting of in-process material Availability of material for manufacturing Unknown status of equipment and batch record WIP might be scrapped due to low and manual visibility of material MES From Past to Present to Future 14

MES From Past to Present to Future Introduction Werum MES concept MES overview A modular approach MES benefits Past Present Future scenarios MES From Past to Present to Future 15 MES Overview a modular approach by PAS-X MES From Past to Present to Future 16

MASTER BATCH RECORD ADMINISTRATION Recipe / MBR development Version control, history, audit trail MBR creation based on libraries Graphical workflow and material flow engine Electronic release workflow (approvals, changes, releases, etc.) Generation of manufacturing documents for paper based manufacturing documentation Define & manage processes in API, formulation & packaging MES From Past to Present to Future 17 WEIGH & DISPENSE GMP Compliant Best Practice Business Processes Interface to different types of scales Easy-to-operate user interface Generation of weighing report Calibration checks and procedure Order and Campaign Weighing, incl. Reconciliation Material point-of-use checks Large selection of weighing methods Waste and Scrap management Industry proven weigh & dispense system enforcing compliance MES From Past to Present to Future 18

Electronic Work Instructions: Easy to operate EBR Paperless production Right First Time Electronic Work Instructions User Guidance Order and workplace control Parallel execution in different workplaces Generation of manufacturing reports and documentation Genealogy Audit Trail Clear workflow guidance for shop floor operators MES From Past to Present to Future 19 Flexible User Guidance Mobile Workstations Portable unit from a single workstation provides full access to all processes Source: Novartis, NJ, USA MES From Past to Present to Future 20

EQUIPMENT MANAGEMENT 1234567890128 Each equipment can be managed as an 'object' Point-of-use identification & status verification Electronic equipment logbook (automatic) Equipment related cleaning recipes Facilitating the plant-wide & paperless electronic logbook MES From Past to Present to Future 21 WAREHOUSE MANAGEMENT SYSTEM Warehouse management (storage places/bin, silos, tanks) Stock keeping of Raw Materials, Finished Goods, Tools, Intermediate Materials Concepts for storage areas (hazardous goods, cold storage) Functions for receiving and dispatching goods Systems for order picking, dispatch control Warehouse and inventory management in combination with ERP functions MES From Past to Present to Future 22

MATERIAL TRACK & TRACE WIP Material Flow Control Dispensing Material flow Definition of transports Controlling of transports Reactor Source: Blend01 Dest.: Press99 Blend01 Press99 Print label Identify label Eliminating risk of material loss or mix-ups MES From Past to Present to Future 23 PROCESS QUALITY CONTROL Deviation and event handling; Analysis and acknowledgement anytime Controlling CQAs and CPPs Focus on deviations / non conformities Traffic light functions to control the process Review-by-exception Follow pre-defined release workflow Significantly improving Right-First-Time MES From Past to Present to Future 24

Electronic Compliant Batch Record MES From Past to Present to Future 25 Integrated MES Solution Standardizations Enterprise Level Production Level Equipment Level MES From Past to Present to Future 26

MES From Past to Present to Future Introduction Werum MES concept MES overview A modular approach MES benefits Past Present Future scenarios MES From Past to Present to Future 27 MES Right First Time Identifying room and reading its status from the system Source: Novartis, NJ, USA MES From Past to Present to Future 28

Operator Guidance and Manufacturing Control MES From Past to Present to Future 29 MES Transform Pain to Benefits (Customer Example) >150 manually managed Recipes Documentation Errors are a constant struggle Operator has no strict guidance through the process Process deviations are late discovered at end of process Inventory not reconciled during production no up to date inventory Equipment status recorded in 100s of paper logbooks Over 6 million entries reviewed annually for correctness 20 data driven MBR templates represent all products 100% Right First Time, system captures work as it is performed Guided procedures enforce compliance Real time deviation reporting / investigation Real time inventory, enabling waste and scrap reporting Equipment management embedded Review by exception only MES From Past to Present to Future 30

Key Benefit Areas of MES Summary Quality Do it right the first time! Minimize lost batches or rework Prevent Errors by means of pro-active online checks Q Product quality Full Compliant Process Identify and eliminate compliance problems No efforts on paperwork Review-by-Exception (incl. CQA, CPP) Reduce Work-In-Progress Save material costs Complete Documentation & Deviation Report Automated up-to-date logbooks Streamlined Event and Deviation Management Reduced Release time through Review by Exception Optimized Process Reduce lead time Tight integration and interaction with DCS / SCADA / PLC MES From Past to Present to Future 31 MES From Past to Present to Future Introduction Werum MES concept MES overview A modular approach MES benefits Present Future scenarios MES From Past to Present to Future 32

PRESENT vertical integration Electronic Batch Recording (EBR) ERP Handling the batch record Electronic Batch Recording Field Level Manufacturing Packaging MES From Past to Present to Future 33 PRESENT product lifecycle integration Manufacturing IT Business Platform Pre Clinical Phase 0 Phase I & II & III Phase IV Launch Commercial Discovery Process Development Clinical Production Commercial Production Manually or Electronic Library 1 EBR 1 MBR PAS-X 1 MBR n EBR 1 MBR 1 EBR 1 MBR 1 EBR Commercial GMP Batches MES From Past to Present to Future 34

Today MBR simulation and validation tool box Faster process testing Create an executable EBR with one click out of MBR Start where ever needed, no sequence enforced Option to disable e-signatures MES From Past to Present to Future 35 Today Electronic recording of shop floor operator Prepare IPC Perform IPC Decision: manually executed by operator More IPC checks? Decision: automatically executed by system End of manufacturing? MES From Past to Present to Future 36

Today Process controlled by decisions MES From Past to Present to Future 37 Today Process controlled by signals (simple) MES From Past to Present to Future 38

Today Process controlled by signals (complex) MES From Past to Present to Future 39 Near Future... Further use of mobile devices, phones, etc., Cloud Computing and fully internet based systems RFID Continuous batch process PAT / QbD initiative of risk-based approach MES is already relevant for those topics. Customers have implemented this already. This will be further developed and established in near future. MES From Past to Present to Future 40

New Devices: Mobility on Tablets Web and Native Applications MES From Past to Present to Future 41 Day after tomorrow unpredictable We will see what the future brings A few possible scenarios MES From Past to Present to Future 42

Future scenario 1 Augmented reality What is it? AR is the concept of merging the digital world with the physical world by having an overlay representing data (either via glasses, screens or by projecting the image onto the physical object) อร อย Glass, say delicious in Thai delicious, Thai Source: http://www.closetcooking.com MES From Past to Present to Future 43 Future scenario 2 Gesture control What is it? Gesture or Motion Control allows the Operator to control the system using gestures instead of typing on keyboard or using the mouse In the pharmaceutical environment this could be especially helpful since keyboards are hard to clean and a potential source of contamination and cross contamination of the product. MES From Past to Present to Future 44

The Future of MES Vision The only place in your plant that will still need paper. MES From Past to Present to Future 45 Thank you Florian Seitz Senior Consultant Werum Asia Support Centre MES From Past to Present to Future 46