towards a smart factory with mes · 2017-10-21 · supporting electronic gmp workflows . define,...

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Towards a Smart Factory with MES Vogel International Pharmaceutical Engineering Forum

Changzhou on 2016, May 12 -13

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MES as a Navigation System to make your Factory Smart

2016 May 12 - 13 2 Vogel International Pharmaceutical Engineering Forum

Guiding through your

business processes

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1 Company Werum

2 What is a MES

3 Smart Factory in Pharma with MES

4 How to run a project smart

5 Summary

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Werum is regarded as No 1 Pharma MES supplier

• 17 out of Top 30 pharma companies are clients

• 800+ PAS-X installation

• Market-leading Pharma MES made in Germany

• 500 employees dedicated for Pharma MES

• Founded 1969


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The largest pharma MES user community


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The Largest Pharma MES community

worldwide

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Werum global footprint

Local presence


Werum K.K. Tokyo, Japan

Werum Germany HQ, Lüneburg

Werum US HQ Parsippany, NJ

Werum Ltd. Asia Support Centre Singapore, Subsidiary Bangkok

San Francisco, CA Cary, NC

Werum SAS Toulouse, France

St. Augustin Hausach Basel

@KMS Sao Paulo, Brazil

Werum Office Shanghai, China

Factory Talk Bangkok, Thailand

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2016 May 12 - 13 8

北京

天津

泰州

无锡

上海

上海

杭州

Werum Customers in China

中国在用客户

Vogel International Pharmaceutical Engineering Forum

德国维隆柯尔柏集团解决方案

南通

昆明

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We help pharma manufacturers

to improve their production

performance and compliance.

What we can do for pharma manufacturers


Improve process / product quality

Monitor and boost manufacturing

performance

Produce less deviations but more yield

Reduce time to market

Meet compliance requirements

Eliminate paper in the factory

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1 Company Werum

2 What is a MES



5 Summary

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Focused Scope on Pharma, but all Pharma


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KPI /

Evaluation Performance

Quality

Deviations

Equipment

management

Production quality review

and approval

Electronic batch recording Operator work in shop floor

MBR

creation

Material tracking

Warehouse

management Goods receipt,

goods shipping,

stock management

Weighing & dispensing

Track & Trace

MES functional overview

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Supporting Electronic GMP Workflows Define, control and document all pharmaceutical activities


Master Batch Record (MBR) Electronic Batch Record (EBR) Completed Batch Record (BR)

Bill of Material

Process Definition

Work Instructions

Version

+

Order Number

Batch Number

Exact Work Center Routing

Right Sequence & Right First Time

+

Actual Values

Exception Summary

Review by Exception

Signatures

1 2 3

Order & EBR creation

(ERP & MES)

EBR review and release

(MES & Operator)

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In Addition to Compliance EBR Creates further Benefits

- 14 - Vogel International Pharmaceutical Engineering Forum

EBR A must in

Pharma

KPIs to

drive

operations

OEE,

RFT,…

Material

Mngmt

ERP

Data

Updates

Equipment

Mngmt

Process

Control &

Monitoring

Reporting

Evaluation

Batch

Release

Review by

Exception

2016 May 12 - 13

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Integration is a must for Smart Factory


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1 Company Werum

2 What is a MES



5 Summary

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MBR Creation


Manual Paperwork Electronic structured graphical way

to define manufacturing process

Changes are easy to manage

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Electronic Batch Recording


Fill entries in a paper form without

guidance

Control of entries by 4-eyes-principle

Late detection of entry errors and GMP

non compliance

System guides operator through the

process like a navigation system

Reduction of entry errors (high Right

First Time rate)

Data directly from automation

Enforcement of GMP compliance

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Integrated Scale Devices for Material Management


Verify correct material & scales

according manufacturing record

Weigh correct amount in bag

Check record for allowed tolerances

Attach label to bag & 2nd copy to the

record

Update SAP inventory

Scan material barcode

Select scale

Weigh correct amount with system

support

MES prints label & updates SAP

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Equipment


Check Logbook

Verify daily checks have been

performed

Perform calculations

Determine the current state of

equipment

Scan equipment barcode

Check status on screen

-Manual Entries

-Manual Calculations

-Manual Checks

-Info not available centrally

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http://www.rsdm-systems.de/products/de/Barcodesysteme/Barcodescanner/2D-Barcodescanner/2D-Laser-Barcodescanner-Symbol-DS6707-USB-anthrazit.html


Integration with Automation Systems


Paper record instructs technician to perform action on control system

Technician logs onto the control system & performs action

Technician records manually value in paper record

Technician checks result is within range per paper record

MES automatically instructs the

Control System to perform the task

Control System accepts set points

starts procedures

Results are sent by Control System

MES checks against the range

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ERP Reporting


Select correct material

Manually input of data in ERP system

Report manually on BR the reporting to

ERP

Technician scans material barcode

MES automatically checks status and

updates ERP with material number,

batch number and quantity and

records the user and date

ERP

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Integration with LIMS


Paper record instructs to log sample

Manually log sample in LIMS – print label

Take sample & insert label into paper record

Confirm sample in LIMS

Sample sent to lab

Quality test

Await result & enter in paper record

MES notifies LIMS of sample event

LIMS creates sample & tells sample

ID to MES

MES prints label

Technician sends sample to labs

Samples tested and results

automatically send to MES

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MES Data for Process Stability & Performance


Lots of Paper – No Data

is it correct?

is it complete?

is it secure?

do you gain knowledge from it?

Turn MES data into knowledge

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GMP Request: Ensure Data Integrity


4 eyes principle ensures correct data

recording

SOPs and training ensures GMP

conform documentation

Manual scale log book ensures cleaned

and calibrated scales

System ensures

correct data and GMP conform documentation

cleaned and calibrated scale with correct precision and approriate weighing range

System validation ensures that system acts according specification

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1 Company Werum

2 What is a MES



5 Summary

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Werum’s unique implementation methodology: Ready – Fit – Build – Run 快速实施


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Faster Implementation

& Reduced Risk

Product based Implementation Approach PAS-X Software, Services & Content


URS or/and

Fit/Gap FS Build Configuration FAT/SAT/Validation

Fit Build Run

MBR Creation & Verification

Go Live

MBR Design, Creation & Verification

Go Live

Traditional Approach

PAS-X Approach

降低风险

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1 Company Werum

2 What is a MES

3 Smart Factory with MES

4 How to run a project

5 Summary

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Benefits with MES: Customer Figures


PaperManagement

RFT Generate BRReview Time Lead Time ProcessAnalysis

Reduction Rest

Customer experience from Bayer, Novartis, Janssen, MSD

J&J: Reduction of Review Time form 45 days to 10 days

93% of 19000 technical BR in 2014 with autorelease

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Bio Factory of the Future


Stainless steel bioreactors

Clean & Steam in place (CIP/SIP)

Extensive preventive maintenance and

working parts

Large footprint

Batch loss in the event of a

contamination

Gamma-irradiated plastic bags

No need for CIP/SIP

Savings in utility costs

Only few working parts

Smaller, more flexible footprint

Disposal of bag in the event of a

contamination

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Amgen: Factory of the Future using PAS-X

Reduce Costs / Increase Efficiency

Reduce Mistakes (Data Collection and Monitoring)

Prevention of Production Errors

Early Problem Intervention

Right First Time Production

Shorter Throughput Time

Less Waste and Rework

Near-Real Time Quality Review by Exception

Greater Visibility of Production Status

Greater Visibility of Eqpt Availability & Status

32 2016 May 12 - 13 Vogel International Pharmaceutical Engineering Forum

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Smart Factory with the Current PAS-X Version


Paperless

Right First Time

Review by Exception

Smart Factory

Today 1990

Compliance

Operational Excellence

Data Integrity

Contionuos Process Validation

Quality Metrics

E-Inspections

PAS-X

3.1.8

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Smart Hardware Integration


Cooperation

with

Usabilty on a new level

Pre-tested and pre-configured solutions

Optimal usage of state of the art HMI

New ways of executing batch records

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Today Tomorrow

Future Human Machine Interaction


Our vision: Mobile and

personalized support of our

users.

Suitable mobile devices, e.g.

Tablets

Glasses

Push tasks to suitable

operators, e.g.

Skills

Current location

Current task

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Future GMP trends…

MES helps ensure data is correct at the time of entry, by the

authorised person, approved and stored securely

MES controls are less error prone, automated data collection

is more robust than manual

2016 May 12 - 13 Vogel International Pharmaceutical Engineering Forum 36

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No. 1 Market leading in Pharma

Complete package out of the box

Best practice pharma knowledge

Integration independent

Fast implementation times and rapid benefit

Werum’s Unique Value Proposition


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The only place

in your plant that will

still need paper.


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towards a smart factory with mes · 2017-10-21 · supporting electronic gmp workflows . define,...

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