MES PREPARATION AS THE KEY TO SUCCESS Learn about a proven and mature methodology to develop a conceptual solution architecture designed to meet the business objectives of the pharma/biotech manufacturing business. Our approach involves a strategy development methodology that brings focus and enables superior solution architecture tailored for Manufacturing Systems solutions, S95, and S88 standards. The key benefit of this methodology is effective alignment of business and technology. Develop a prioritized capital project planning roadmap to meet business objectives. Strategic Technology Management process for MES Applications for IT Enterprise Architecture. Discover a holistic visual tool that enables harmony between all departments stakeholders. Gilad Langer, Director of Automation & MIS, NNE

1. MES
Preparation
is the key
to success!
2nd Annual, Pharmaceutical MES
Conference

2. Business
objectives
1
Business
model
2
Business
processes
3
Information,
data and
documents
4
Application
types
5
Infrastructure
6
Enabling
services
7
Where do we start?
• What are the business Drivers?
• Cost Benefit Analysis
• ROI Analysis
• Business Justification (Business Case)
• Budget Planning
• What are the Manufacturing Systems Strategies?
• System Scope
• System & Vendor Selection Processes
• Technology Evaluation & Standardization
• What will a systems solution look like and require?
• Requirement Analysis & Specification
• Feasibility Studies & Conceptual Design
• System Specification & Architectural Design
• What else will be needed?
• Qualification strategy and planning
• Risk Analysis & Impact Assessments
• Governance, Program and Roll-out planning
• Ramp-up & Optimization Planning
• System Life Cycle Planning

3. Procurement
/ Receiving Production
Fill-Finish /
Packaging Shipping
Material & Resources Flow
Scheduling &
Dispatching
Material Requirement
Planning
Master Production
Planning
Sales & Demand
Planning
Process information
Operations Planning
Develop / Approval
R&D, Discovery
What Does a Typical Automation & IT Landscape Look Like?
4
CTMS
PLM
PDM
CAD
TMS
Manufacturing
System Solution
LIMS
QMS
BI
EAM
APS
ERP
ERP
ERP
Batch/
DCS SCADA
Historian
MES MI

4. Putting it all together?
5
Procurement
/ Receiving Production
Fill-Finish /
Packaging Shipping
Process information
Operations Planning
Develop / Approval
R&D, Discovery
Scheduling &
Dispatching
Material Requirement
Planning
Master Production
Planning
Sales & Demand
Planning
Manufacturing
System Solution
CTMS
PLM
PDM
CAD
TMS
LIMS
QMS
BI
EAM
APS
ERP
ERP
ERP
Batch/
DCS SCADA
Historian
MES MI
Fire wall

5. Avoid Building a House From a Pile of Bricks
6

6. Business
objectives
1
Business
model
2
The Manufacturing Enterprise Architecture Model
MES Blueprint
7
The 7 layers
Business
processes
3
Information,
data and
documents
4
Application
types
5
Infrastructure
6
Enabling
services
7
Value Cost

7. As-Is
Current State
(what we have now)
To-Be
Target/Future State
(what we will have in the future)
ANALYZE TARGET JUSTIFY PLANMOBILIZE

8. Defining the MES Solution Strategy
MES Application Enterprise Architecture (Blueprint)
• Functional Requirements
• Data Requirements
• Platform requirements
• Interface Requirements
• Infrastructure Requirements
• Support Requirements
• Other Requirements
Business
objectives
1
Business
model
2
Business
processes
3
Information,
data and
documents
4
Application
types
5
Infrastructure
6
Enabling
services
7
Common Vision
Overall Scope
Data & Information Strategy URS
Deployment Strategy

9. Determining the Real Business Objectives
Practical Example
11
New Product Intro Stable Production Volumes Patent Expiry
Agile Manufacturing Effective Documentation Process Capability Supply Chain Reliability Operational Excellence
Flexibility Compliance Quality Volumes Competitiveness
Time
Review by
Exception
Batch
Reporting &
Verification
Electronic Log
Books
Recipe/
Workflow
Execution
Product &
Process
Definition
Batch Control
Transport
Control
Manufacturing
Intelligence
Quality
Monitoring
Data
Collection
Laboratory
Data
Management
Maintenance
Management
Calibration
Management
Quality Test
Workflow
Execution
Enterprise
Resource
Planning
Scheduling
Unit Control
Automation&ITCapabilitiesBusinessObjectives
Recipe/
Workflow
Execution
Product &
Process
Definition

10. Automation & MIS Technology Investment with a Purpose
12

11. 13

12. Understanding the Data & Application Landscape

13. Workflow Analysis & Requirement Specification
15
MES Requirements
Specification
• Functional Requirements
• Data Requirements
• Platform requirements
• Interface Requirements
• Infrastructure Requirements
• Support Requirements
• Other Requirements

14. Example of Operational Flow Diagram
16

15. URS is a Component of the Enterprise Architecture
17
MES Requirements Specification
• Functional Requirements
• Data Requirements
• Platform requirements
• Interface Requirements
• Infrastructure Requirements
• Support Requirements
• Other Requirements

16. Evaluating a Manufacturing Systems Solution
Technology, Deployment, & Support
Category Description
1-Company
Company viability, ownership, location, industry knowledge,
geography, size, etc.
2-Solution How well does the solution fit my technical and business requirements.
3-Functionality Functionality fit to requirements
4-Interfaces
Availability and technological fit of interfaces for level 4 and level 2
systems interoperability
5-Delivery Model
Model by which solutions are delivered incl. customizations, resources,
project approach, qualification support, etc.
6-Technology
Product technology platform, legacy components, completeness,
scalability, deployment, etc.
7-Confi & Support
How easy is it to live with the product, maturity, roadmap, version
support, modularization, upgradability
Score Rank Score Rank Score Rank Score Rank Score Rank Score Rank Score Rank Score Rank
Vendor I 191 1 153 1 471 1 200 1 125 2 120 1 207 1 1467 1
Vendor II 181 2 134 2 450 2 189 2 130 1 100 2 205 2 1389 2
Vendor III 112 3 103 3 343 3 188 3 71 3 93 3 159 3 1069 3
7 - Config &
Support
Totals
Category
Vendor 1 - Company 2 - Solution 3 - Functionality 4 - Interfaces
5 - Delivery
Model
6 - Technology
0
1
2
3
4
Rank Distribution by Category
Vendor I
Vendor II
Vendor III

17. Manufacturing Systems Solution Scope
19
Manufacturing
Systems
Governance
Manufacturing
Systems
Solutions
Manufacturing
Systems
Backbone
Conceptualize Plan
(Basic & Detailed Design)
Build
(Develop, Configure & Test)
Operate
Front End Design /
Basic & Detailed Engineering
Service &
Support
Install & Qualification
Service &
Support
Interoperability
Deploy
Qualification
MES Deploy
Infrastructure
Strategy
Business Case &
Solution Strategy
System Scope
& Selection
Governance
Framework
Change
Management
& Upgrade
Technology governance
Competence governance
Programme management
Application governance
Project management
Qualification
Strategy
Qualification
Planning
Life cycle
planning
Design & Deploy
Go
Live

18. Implementation strategies
20
Product C
Product D
Product B
Product A
W&D Granulation Drying Blending Compression Coating
Horizontal implementation strategy
MES is introduced by product
Verticalimplementationstrategy
MESisintroducedbyProcess

19. Evaluation of implementation strategy
21
Product B
Product A
W&D Granulation Drying Blending Compression Coating
ValueInvestment

20. Site MES readiness assessment
23
Technology
• Maturity and fit of existing infrastructure at the
site to a modern MES solution
• Availability and readiness of other business and
automation system to integrate with MES
solution.
• Prioritizes list of gaps that need to be
addressed prior to embarking on an MES
initiative.
Supporting services
• Maturity of site IT/IS organisation to support
MES solution
• Maturity of SOP and governance to embrace
an operational MES solution
• Prioritises list of gaps that need to be
addressed prior to embarking on an MES
initiative
Existing or future deployment
• Process vs Product (Vertical vs Horizontal)
MES solution scope and strategy
• What business process and activities are
covered
• What system to integrate to

21. The Value of ‘Enterprise Architecture’ for Manufacturing IT
24
• Design solutions based
on real needs of the
business
• Use systematic support
and implementation of
best practices.
Operational Excellence
• Drive agility by
anticipating
requirements of new
products and ramp up
of production capacity,
with seamless
compliance.
Faster Delivery
• Evaluate the impact of
change and increase
speed in the solutions
evaluation due to the
architectural overview
and standardisation
Improved ReadinessCommon Framework
• Structures and
processes that lead to
effective and timely
decisions on the usage
and deployment of
automation and IT, and
execution of projects
TextBLUEPRINT WITH ARCHITECTURE + ROADMAP
TODAY TOMORROW FUTURE

22. Thank you
For further information please contact
Gilad Langer, Ph.D.
Director, Automation & MIS
+1 415-405-6743
gidl@nne.com