MES S E iddle Ages - ISPE Th © Werum Software & Systems, Florian Seitz MES – From Past to Present to Future 5 What is MES? MES stands for Manufacturing Execution System

19-July-2013 © Werum Software & Systems, Florian Seitz MES – From Past to Present to Future 1


MES Middle Ages – Evolution – Space

Florian Seitz Werum Asia Support Centre


From Past to Present to Future

15 yearsrs

Nokia 5100

1998

iPhone 5

2013


From Past to Present to Future

14 yearsrs

Nokia 5100

1987

iPhone 5

2012


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).


Introduction Werum I

MES concept MM

Past – Present – Future scenarios P

MES – From Past to Present to Future

MES overview – A modular approach MM

MES benefits MM


Werum at a Glance

Werum AG, Headquarters, Lueneburg, Germany

Werum America Inc., Headquarters, Parsippany, NJ, USA

Best-in-class MES product for Pharma & Biotech Professional services Customer satisfaction & long term partnerships

480+ employees Founded 1969 Constant growth Strong financials


Your Leading MIT Partner for Life Sciences

Werum K.K. Tokyo, Japan

Werum Germany HQ, Lueneburg

Werum US HQ Parsippany, NJ

Werum Ltd. Asia Support Centre Singapore, Subsidiary Bangkok

S. Francisco, CA

Cary, NC

Hausach

Werum SAS Toulouse, France

St. Augustin

Basel


Revenue by Region

Revenue by Industry

Werum & PAS-X Success Stories

Pharma 50%

Biotech and API

40%

Others 10%

USA 45%

Europe 45%

Asia Pacific

10%

Stable Growth per Year Employees

380 400 450 470 490

2009 2010 2011 2012 2013(e.)

h + 15 %


International Key Customers in Asia/Pacific


Introduction Werum II

MES concept MM




MES benefits MM


Producing Paper & Pharmaceuticals...

Looks familiar? Manufacturing pharmaceutical products and flooding yourself in paper documents?


Where do we come from?

ERP

MES

Equipment


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 concept M




MES benefits MM


MES Overview – a modular approach by PAS-X


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


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


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

Clear workflow guidance for shop floor operators

Audit Trail


Flexible User Guidance – Mobile Workstations

Source: Novartis, NJ, USA

Portable unit from a single workstation provides full access to all processes


EQUIPMENT MANAGEMENT

Each equipment can be managed as an 'object' Point-of-use identification & status verification Electronic equipment logbook (automatic) Equipment related cleaning recipes

1 234567 890128

Facilitating the plant-wide & paperless electronic

logbook


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


MATERIAL TRACK & TRACE – WIP Material Flow Control

Reactor Dispensing Material flow ▪ Definition of transports ▪ Controlling of transports

Print label Identify label

Blend01 Press99

Source: Blend01 Dest.: Press99

Eliminating risk of material loss or mix-ups


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


Electronic Compliant Batch Record


Integrated MES Solution – Standardizations

Enterprise Level

Production Level

Equipment Level



MES concept M



MES overview – A modular approach M

MES benefits MM


MES Right First Time

Identifying room and reading its status from the system

Source: Novartis, NJ, USA


Operator Guidance and Manufacturing Control


MES – Transform Pain to Benefits (Customer Example)

>150 manually managed Recipes 20 data driven MBR templates represent all products

Documentation Errors are a constant struggle

100% Right First Time, system captures work as it is performed

Operator has no strict guidance through the process Guided procedures enforce compliance

Process deviations are late discovered at end of process

Real time deviation reporting / investigation

Inventory not reconciled during production – no up to date inventory

Real time inventory, enabling waste and scrap reporting

Equipment status recorded in 100s of paper logbooks

Equipment management embedded

Over 6 million entries reviewed annually for correctness Review by exception only


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

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

Q Product quality



MES concept M

Present – Future scenarios


MES overview – A modular approach M

MES benefits MM


PRESENT – vertical integration Electronic Batch Recording (EBR)

ERP

Field Level

Manufacturing Packaging

Electronic Batch

Recording

Handling the batch record


PRESENT – product lifecycle integration Manufacturing IT Business Platform

Manually or Electronic

Discovery

Pre Clinical Phase 0 Phase I & II & III Phase IV

Process Development

Clinical Production

PAS-X PASSS-XXX

1 MBR 1 EBR

Library 1 EBR 1 MBR

1 EBR 1 MBR

PPPAAASSSSSSSSSSSSSSSSSSSS XXX

V Launch h Commercial

Commercial Production

1 MBR n EBR

Commercial GMP Batches


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


Today – Electronic recording of shop floor operator

Decision: automatically executed by system “End of manufacturing?”

Decision: manually executed by operator “More IPC checks?”

Prepare IPC

Perform IPC


Today – Process controlled by decisions


Today – Process controlled by signals (simple)


Today – Process controlled by signals (complex)


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.


New Devices: Mobility on Tablets Web and Native Applications


Day after tomorrow – unpredictable

We will see what the future brings…

A few possible scenarios


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)

Source: http://www.closetcooking.com

Glass, say delicious in Thai

อร่อย delicious, Thai


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.


The Future of MES – Vision

The only place in your plant that will still need paper.


Thank you

Florian Seitz Senior Consultant

Werum Asia Support Centre

Documents

MES S E iddle Ages - ISPE Th © Werum Software & Systems, Florian Seitz MES – From Past to Present to Future 5 What is MES? MES stands for Manufacturing Execution System