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© Werum IT Solutions. Confidential information. All rights reserved.
Towards a Smart Factory with MES Vogel International Pharmaceutical Engineering Forum
Changzhou on 2016, May 12 -13
《制药业》
© Werum IT Solutions. Confidential information. All rights reserved.
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
《制药业》
© Werum IT Solutions. Confidential information. All rights reserved.
2016 May 12 - 13 3 Vogel International Pharmaceutical Engineering Forum
1 Company Werum
2 What is a MES
3 Smart Factory in Pharma with MES
4 How to run a project smart
5 Summary
《制药业》
© Werum IT Solutions. Confidential information. All rights reserved.
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
2016 May 12 - 13 4 Vogel International Pharmaceutical Engineering Forum
《制药业》
© Werum IT Solutions. Confidential information. All rights reserved.
The largest pharma MES user community
2016 May 12 - 13 5 Vogel International Pharmaceutical Engineering Forum
《制药业》
© Werum IT Solutions. Confidential information. All rights reserved.
2016 May 12 - 13 6 Vogel International Pharmaceutical Engineering Forum
The Largest Pharma MES community
worldwide
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© Werum IT Solutions. Confidential information. All rights reserved.
Werum global footprint
Local presence
2016 May 12 - 13 7 Vogel International Pharmaceutical Engineering Forum
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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© Werum IT Solutions. Confidential information. All rights reserved.
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
《制药业》
© Werum IT Solutions. Confidential information. All rights reserved.
We help pharma manufacturers
to improve their production
performance and compliance.
What we can do for pharma manufacturers
2016 May 12 - 13 9 Vogel International Pharmaceutical Engineering Forum
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
《制药业》
© Werum IT Solutions. Confidential information. All rights reserved.
2016 May 12 - 13 10 Vogel International Pharmaceutical Engineering Forum
1 Company Werum
2 What is a MES
3 Smart Factory in Pharma with MES
4 How to run a project smart
5 Summary
《制药业》
© Werum IT Solutions. Confidential information. All rights reserved.
Focused Scope on Pharma, but all Pharma
2016 May 12 - 13 11 Vogel International Pharmaceutical Engineering Forum
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© Werum IT Solutions. Confidential information. All rights reserved.
2016 May 12 - 13 12 Vogel International Pharmaceutical Engineering Forum
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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© Werum IT Solutions. Confidential information. All rights reserved.
Supporting Electronic GMP Workflows Define, control and document all pharmaceutical activities
2016 May 12 - 13 13 Vogel International Pharmaceutical Engineering Forum
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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© Werum IT Solutions. Confidential information. All rights reserved.
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
《制药业》
© Werum IT Solutions. Confidential information. All rights reserved.
Integration is a must for Smart Factory
2016 May 12 - 13 15 Vogel International Pharmaceutical Engineering Forum
《制药业》
© Werum IT Solutions. Confidential information. All rights reserved.
2016 May 12 - 13 16 Vogel International Pharmaceutical Engineering Forum
1 Company Werum
2 What is a MES
3 Smart Factory in Pharma with MES
4 How to run a project smart
5 Summary
《制药业》
© Werum IT Solutions. Confidential information. All rights reserved.
MBR Creation
2016 May 12 - 13 17 Vogel International Pharmaceutical Engineering Forum
Manual Paperwork Electronic structured graphical way
to define manufacturing process
Changes are easy to manage
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© Werum IT Solutions. Confidential information. All rights reserved.
Electronic Batch Recording
2016 May 12 - 13 18 Vogel International Pharmaceutical Engineering Forum
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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© Werum IT Solutions. Confidential information. All rights reserved.
Integrated Scale Devices for Material Management
2016 May 12 - 13 19 Vogel International Pharmaceutical Engineering Forum
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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© Werum IT Solutions. Confidential information. All rights reserved.
Equipment
2016 May 12 - 13 20 Vogel International Pharmaceutical Engineering Forum
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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© Werum IT Solutions. Confidential information. All rights reserved.
Integration with Automation Systems
2016 May 12 - 13 21 Vogel International Pharmaceutical Engineering Forum
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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© Werum IT Solutions. Confidential information. All rights reserved.
ERP Reporting
2016 May 12 - 13 22 Vogel International Pharmaceutical Engineering Forum
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
《制药业》
© Werum IT Solutions. Confidential information. All rights reserved.
Integration with LIMS
2016 May 12 - 13 23 Vogel International Pharmaceutical Engineering Forum
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
《制药业》
© Werum IT Solutions. Confidential information. All rights reserved.
MES Data for Process Stability & Performance
2016 May 12 - 13 24 Vogel International Pharmaceutical Engineering Forum
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
《制药业》
© Werum IT Solutions. Confidential information. All rights reserved.
GMP Request: Ensure Data Integrity
2016 May 12 - 13 25 Vogel International Pharmaceutical Engineering Forum
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
《制药业》
© Werum IT Solutions. Confidential information. All rights reserved.
2016 May 12 - 13 26 Vogel International Pharmaceutical Engineering Forum
1 Company Werum
2 What is a MES
3 Smart Factory in Pharma with MES
4 How to run a project smart
5 Summary
《制药业》
© Werum IT Solutions. Confidential information. All rights reserved.
Werum’s unique implementation methodology: Ready – Fit – Build – Run 快速实施
2016 May 12 - 13 27 Vogel International Pharmaceutical Engineering Forum
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© Werum IT Solutions. Confidential information. All rights reserved.
Faster Implementation
& Reduced Risk
Product based Implementation Approach PAS-X Software, Services & Content
2016 May 12 - 13 28 Vogel International Pharmaceutical Engineering Forum
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
《制药业》
© Werum IT Solutions. Confidential information. All rights reserved.
2016 May 12 - 13 29 Vogel International Pharmaceutical Engineering Forum
1 Company Werum
2 What is a MES
3 Smart Factory with MES
4 How to run a project
5 Summary
《制药业》
© Werum IT Solutions. Confidential information. All rights reserved.
Benefits with MES: Customer Figures
2016 May 12 - 13 30 Vogel International Pharmaceutical Engineering Forum
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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© Werum IT Solutions. Confidential information. All rights reserved.
Bio Factory of the Future
2016 May 12 - 13 31 Vogel International Pharmaceutical Engineering Forum
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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© Werum IT Solutions. Confidential information. All rights reserved.
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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© Werum IT Solutions. Confidential information. All rights reserved.
Smart Factory with the Current PAS-X Version
2016 May 12 - 13 33 Vogel International Pharmaceutical Engineering Forum
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
2016 May 12 - 13 34 Vogel International Pharmaceutical Engineering Forum
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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© Werum IT Solutions. Confidential information. All rights reserved.
Today Tomorrow
Future Human Machine Interaction
2016 May 12 - 13 35 Vogel International Pharmaceutical Engineering Forum
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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© Werum IT Solutions. Confidential information. All rights reserved.
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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© Werum IT Solutions. Confidential information. All rights reserved.
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
2016 May 12 - 13 37 Vogel International Pharmaceutical Engineering Forum
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© Werum IT Solutions. Confidential information. All rights reserved.
38 2016 May 12 - 13 Vogel International Pharmaceutical Engineering Forum
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© Werum IT Solutions. Confidential information. All rights reserved.
The only place
in your plant that will
still need paper.
39 2016 May 12 - 13 Vogel International Pharmaceutical Engineering Forum
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