Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control...
Transcript of Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control...
![Page 1: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/1.jpg)
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
Overview
V03
![Page 2: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/2.jpg)
(Confidential – For Internal Use Only)
Copyright © 2008 Rockwell
Automation, Inc. All rights reserved.
2
Life Sciences Industry Challenges
In the Industry’s Own Words:
• “Reduce spending per brand by 15 to 20% in the U.S.”
• “Reducing inventory by $400 million and saving $1.2 billion in procurement by 2008”
• “Redesigning all of our end-to-end processes”
• “Strengthened capabilities in vertical integration to secure future cost competitiveness”
• “Scale in manufacturing and infrastructure in low cost regions”
• “Integration of a global manufacturing network”
• “Creation of one Pharmaceutical Development “center of excellence” between R&D and Manufacturing”
Driving to Sustainability & Continuous Improvement
Source: Various life sciences manufacturing's investor relations presentations
![Page 3: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/3.jpg)
Copyright © 2008 Rockwell Automation, Inc. All rights reserved. 3
Life Sciences Industry Challenges
• Economic pressures
– Globalization
– Pricing pressure
– Litigation costs
– Government pricing restrictions
• Changing regulatory environment
– Risk-based manufacturing
– Quality by Design
• Portfolio pressures
– Move to Biotech
– New delivery mechanisms
– Targeted treatments
– Shrinking pipeline
![Page 4: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/4.jpg)
Copyright © 2008 Rockwell Automation, Inc. All rights reserved. 4
Challenges faced by the Life Sciences Industry
• Time and cost for bringing new
products to market
– 10-12 years to bring new drugs to
market at a cost of $890M
– 1 in 20 new drugs meet FDA approval
with 8-10 years of patent life
• Global production efficiency
– Quality checks and quarantine time
account for 50% of manufacturing
cycle times
– Biotech manufacturing estimated to be
significantly capacity restrained
– Two-thirds of life sciences companies
view boosting operating efficiency as
their top business goal
• Quality and compliance processes
– In 2003, FDA introduces new
risk-based approach for regulatory
compliance
– Significant focus on quality-by-
design and process optimization
– Compliance and validation remain
the most important categories of
capital spending
![Page 5: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/5.jpg)
Copyright © 2009 Rockwell Automation, Inc. All rights reserved. 5
Operational Excellence
• To achieve Operational Excellence,
• tools
• methods
• based on standards
must be established to simultaneously meet the quality, regulatory and productivity requirements
Adress simultaneously quality, regulatory and productivity requirements.
![Page 6: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/6.jpg)
Copyright © 2009 Rockwell Automation, Inc. All rights reserved. 6
MES drives Operational Excellence
MES realizes benefits for visibility, tracking and control
Exposing and synchronizing
real time information
• Process reliability, continious improvement
• Business process re-engineering
• Real-Time enterprise
• Data collection & warehousing • Multiplatform visualization • KPI reporting - dashboards • Integration Frameworks
A product centric process
view of order and status
• Regulatory compliance • Lean manufacturing • Quality by design
• Track & trace • Right first time • Order & resource status
Interactive business rules to
manage process work flow
• Asset optimization • Demand driven manufacturing • Design to manufacture • Security
• Equipment effectiveness • Electronic batch recording • Batch release • Intelligent control system
![Page 7: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/7.jpg)
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
Application Portfolio
7 7
Production Management
• Manage Recipes
• Manage Master Data
• Manage Specification
Manufacturing
Business Intelligence
• Turn data into information
• Visibility into the shop floor
Production Performance • OEE • KPIs • Dashboards
Production, Quality &
Maintenance Tracking
• Material tracking
• Equipment tracking
• Personal tracking
Real-time Environmental
Management
• Qualified building automation
Energy Optimization • Monitor usage • Optimize
Serialization / Track&Trace • Prevent counterfeiting • ePedigree
Model Predictive Process
Control & Optimization
• Apply process understanding to controls
• Advanced controls
• PAT
Production Execution
• Collect data from shop floor
• Drive manual activities (EBR)
• Manage Deviations
![Page 8: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/8.jpg)
Copyright © 2009 Rockwell Automation, Inc. All rights reserved. 8
MES equation: Applied Capabilities = Value
Production Management Production Analysis
Manufacturing Business Intelligence
Production Management Production Performance
Production, Quality &
Maintenance Tracking Production Execution
Model Predictive Process
Control & Optimization
Common Operational
Data Warehouse (Transactional)
Real-time
Environmental
Management
Data Historian (Timeseries)
Production
Performance
Third Party Systems
Enterprise
Resource
Planning
Automation
Production Execution | Dispense | EBR Production Execution | Quality
![Page 9: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/9.jpg)
Applications of FT Pharma Suite
Production Management Production Analysis Quality Management
Production Execution Dispense EBR
Platform
9 Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
![Page 10: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/10.jpg)
10 10
FactoryTalk Pharma Suite Overview
Comprehensive Production Management
Key values
• Applications tailored to the needs of regulated
industries ensure compliance at lower cost
• Support for the complete drug manufacturing
life cycle helps to improve time to market
• State-of-the-art technology reduces TCO
• Implementation by customer, RA or partner
• Supports multiple industry segments including
Pharma, Biotech, Med Devices, Nutraceuticals
• Covers the whole drug life-cycle
– R+D, Clinical, Primary and Secondary
Production
• Feature-rich applications
• Compliant with regulations
– FDA, EU, GxP,..
• Based on a proven platform
– Modular, flexible, extensible and scalable
• Comprehensive integration with business and
automation layer systems
• Alignment with standards (S88, S95, etc)
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
Production Management Production Analysis Quality Management
Production Execution Dispense EBR
Platform
![Page 11: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/11.jpg)
11 Copyright © 2008 Rockwell Automation, Inc. All rights reserved. 11
FactoryTalk Pharma Suite Production Management Application
• Management of master data – Materials – Bill of materials – Routes – Master recipes
• Process order management – Order explosion – Dispatching
• Inventory management – Batch and sublot management – Visibility into inventory
• Equipment management – Scales, Rooms, Containers, etc
• Compliance – Versioning, Audit Trail, eSignatures
GxP-compliant recipe management
Key values
• Reduces risk of non-conformance by GxP-compliant data and recipe management
• Provides control on what happens and when on the shop floor
• Provides visiblity into production status and shop-floor inventory
• Instant access to equipment status and history – without paper
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
Production Analysis Quality Management
Production Execution Dispense EBR
Platform
Production Management
![Page 12: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/12.jpg)
12 Copyright © 2008 Rockwell Automation, Inc. All rights reserved. 12
FactoryTalk Pharma Suite Production Execution Application
Visibility and Tracking for the shop-floor
Key values
• Enforces material and equipment is used according to specifications
• Ensures correct and complete documentation of material, equipment and personnel used throughout the process
• Eliminates manual bookings for order status, material consumed and produced in ERP
• Automatically tracks WIP
• Controls inventory on the shop-floor
• Pre-defined workflows for Track&Trace
– Material receive, Material issue
– Material relocation, Material split
– Material consumption, Material produce
– Room & container cleaning
• Enforcement of processes / specifications – Correct material/batch
– Calibrated, clean and correct equipment
– Qualified personnel
• Tracking of material, equipment, personnel
• Compliant handling of exceptions
• Labeling, Label history, Re-print
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
Production Management Production Analysis Quality Management
Production Execution Dispense EBR
Platform
![Page 13: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/13.jpg)
13 13
FactoryTalk Pharma Suite Dispense
Key values
• Guides operator through complex weighing processes and therefore prevents errors
• Ensures complete and correct documentation
• Eliminates manual calculations
• Scales interface makes 2nd operator redundant
• Review by exception reduces time and effort for review and investigations
Compliant weighing operations
• Pre-defined weighing workflows / methods
– Recipe weighing, Campaign weighing
– Cost center weighing, Removal weighing
– Scales test & calibration
– Booth & container cleaning
• Real-time scales interface
– Comprehensive list of supported scales
– Scales identity check
• Potency correction / compensation
• Compliant handling of exceptions
• Weighing report
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
Production Analysis Quality Management
Production Execution Dispense EBR
Platform
Production Management
![Page 14: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/14.jpg)
Copyright © 2008 Rockwell Automation, Inc. All rights reserved. 14
FactoryTalk Pharma Suite Electronic Batch Recording
• Graphical Recipe Workbench
– User-friendly and intuitive modeling of process
and material flow, equipment, etc
– Rich set of pre-defined recipe building blocks
– Freedom to define new recipe building blocks
– Simulation and verification
• Integrated Recipe Execution
– Focused on the needs of the shop-floor operators
– Comprehensive Integration
• Configurable Review & Approval workflows
• Flexible and configurable Batch Reporting
• Aligned with standards
Key values
• Improves time-to-recipe and helps to simplify tech-transfer and scale-up
• Significantly reduces procedural and operator errors by guiding operators through complex processes
• Prevents documentation errors by capturing data from devices / automation layer
• Reduces batch review cycle-time and effort allowing „review by exception“
Gapless electronic batch documentation
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
Production Analysis Quality Management
Production Execution Dispense EBR
Platform
Production Management
![Page 15: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/15.jpg)
15 15
FactoryTalk Pharma Suite Quality Management
• Pre-defined workflows for quality operations
in production, warehouse and lab
– Sampling
– In Process Control
– SPC / SQC
• Comprehensive tracking of process activities
• Sampling plans, Supplier Management
• Interfaces to Automation Layer, Laboratory
Equipment and LIMS
• Seemless integration with Dispense, EBR,
Warehouse, etc
Key values
• Minimizes risk of non-conformance by enforcement of quality requirements
• Automatic capturing of quality data provides correct and comprehensive batch records
• Streamlines IPC activities at the line and in the IPC laboratory
Include quality operations into your batch documentation
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
Production Analysis Quality Management
Production Execution Dispense EBR
Platform
Production Management
![Page 16: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/16.jpg)
16 Copyright © 2008 Rockwell Automation, Inc. All rights reserved. 16
FactoryTalk Pharma Suite Production Analysis
• Flexible definition of key performance
indicators for equipment, quality and
processes
• Line monitoring cockpit / downtime analysis
• Definition and monitoring of limits and
notification of limit violations
• Role-based dashboards with standard KPIs
• Reporting and analytics
• Seemless integration with Dispense, EBR,
Quality, Warehouse, etc
• Automated collection of real-time data
Key values
• On-demand visibility for decision support and continuous process improvement
• Process improvements based on objective, accurate and timely data
• Configurable and scalable to ensure that is measured and monitored what is important
Improve overall efficiency and analyze downtime issues
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
Production Analysis Quality Management
Production Execution Dispense EBR
Platform
Production Management
![Page 17: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/17.jpg)
17 17
FactoryTalk ProductionCentre Platform
Key values
• Security and stability
• Freedom of platform choice
• Ease of integration
• Configuration versus customization
• Easy to extend
• Deployment by IT organizations, partner, RA
• J2EE – proven technology for mission-critical
enterprise applications
– Security and stability
– Scalability without limits
• Service Oriented Architecture (SOA)
– Feature rich business layer
– Supports rich and thin (HTML) clients
• Variety of supported platforms
– IBM WebSphere, JBoss, WebLogic
– Windows, Linux, Solaris Enterprise
– SQL Server, ORACLE
• Multi-tier data model
• Built-in application development framework
– Comprehensive, flexible and extensible
FactoryTalk SOA – Reliable and scalable Enterprise Architecture
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
Production Analysis Quality Management
Production Execution Dispense EBR
Platform
Production Management
![Page 18: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/18.jpg)
18 Copyright © 2008 Rockwell Automation, Inc. All rights reserved. 18
FactoryTalk Pharma Suite Business and Automation System Integration
• Business System Integration with FT Integrator
– Standard adapters to various ERP systems like
SAP, ORACLE, JDEdwards, etc
– Pre-defined interface scenarios
– Flexible and reliable middleware platform based on
industry standards like S95 and B2MML
• Flexible integration with 3rd party middleware like
IBM WebSphere or SAP NetWeaver XI using
ProductionCentre JCA-Adapter
• Integration of process parameters, events and
historical data using industry-standards
– FT LiveData (OPC DA)
– FT A+E (OPC Alarm+Events)
– FT Historian, OPC HDA
Key values
• Flexible and cost-effective integration with business and automation systems
• Support for Rockwell and 3rd party systems
• Seamless integration in existing IT infrastructure
• Reliable and proven technology
• Service-oriented architecture (SOA) provides for open interfaces based on industry-standards
Comprehensive integration with business and automation systems
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
Enterprise Resource Planning
Automation
Production Management Production Analysis Quality Management
Production Execution Dispense EBR
3rd-party Controller 3rd-party HMI 3rd-party Historian 3rd-party BES/DCS
![Page 19: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/19.jpg)
The Evolution of FactoryTalk Pharma Suite
FactoryTalk Pharma Suite
CAPA
EDHR
EBR (paper
on glass)
Prod. Analytics
2.0
Quality, CAPA
Scheduling
Clinical
3.0
EBR
Warehouse
4.0
Dispense
Production Mgt.
1.0
• As RA continuously grow FactoryTalk to cover the complete information space, the current LS MES/IS offering will be merged into the FactoryTalk platform
• FT Pharma Suite will be built on the strength of our existing offering RS PMX and FT ProductionCentre
• Multi-release roadmap,
comprehensive offering by 2011
• No forced migration for PMX
customers – convergence according
to your business requirements
• Ongoing, significant investment in the
LS information solutions offering
1.1
19 Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
![Page 20: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/20.jpg)
Copyright © 2008 Rockwell Automation, Inc. All rights reserved. 20
FactoryTalk Pharma Suite – Driven by YOU
• Functional enhancements
• Technology direction
• Yearly voting process determines major parts
of the product scope
• Forum for customer interaction
• A platform to provide real-life experience to
Rockwell Automation’s development group
• Rockwell Automation shares early product
roadmap visions
• Regular meetings
– Monthly (WebEx/PhoneConf)
– Semiannual face-to-face
others...
The Customer Advisory Board drives the direction of FactoryTalk Pharma Suite
20 Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
![Page 21: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/21.jpg)
Copyright © 2009 Rockwell Automation, Inc. All rights reserved. 21
FactoryTalk ProductionCentre
FactoryTalk Pharma Suite is built on a platform that is proven in many installations!
• ProductionCentre hosts the biggest single
MES serving over 3000 users at 28 sites
with further 18 being deployed
• Installed at over 150 sites
• More than 100 customers world-wide with
over 10,000 users
• Deployed in a variety of industries
• Medical Devices
• Electronics
• Food / Beverage
• Automotive
21 Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
![Page 22: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/22.jpg)
Summary
• Feature-rich MES applications tailored to the needs of Life Sciences industries help
customers to ensure regulatory compliance at lower cost
• Leverages Rockwell’s long-time experience building Life Sciences MES applications
• Based on a state-of-the-art software platform proven in many installations
• Industry-standard technology allows for reduced cost of ownership (TCO)
• Works stand-alone as well as tightly integrated with ERP
• Minimum hardware requirements for small systems – yet scalable to 1000‘s of users
• Can be deployed by customer, RA or partner
22 Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
![Page 23: Life Science MES Strategy - קונטאל · 2016-04-06 · Batch release •Intelligent control system . ... according to specifications • Ensures correct and complete documentation](https://reader034.fdocuments.us/reader034/viewer/2022042409/5f25239a20c5c05785451664/html5/thumbnails/23.jpg)
Copyright © 2009 Rockwell Automation, Inc. All rights reserved.
Thank You