the California Express Solution

Introducing
the California
Express Solution
Today’s Agenda
 California Update
 California Compliance: A Broad Enterprise Impact
 Introducing the California Express Solution
• California Express Solution Team
• Solution Overview
• Solution Components
• Role & Responsibilities
• Compliance Planning & Roadmap
 California Express Solution: A Foundation for Business Value
 Further Information/Next Steps
• Regional Manufacturer Workshops
• 1-Day California Readiness Assessment
 Q&A
California Express Solution Team
Today’s Speakers
Graham Clark
VP Business Development
SupplyScape
David DeJean
Director Serialized Products
Systech
Janine Brown
Principal Consultant
HP
Gregg Metcalf
Industry Marketing Manager
Nosco
California Express Solution Team
California Update
Monitor for Regular Detailed Updates
WA
Regulations
Pedigree
OR
MT
ID
Serialization
NV
California
Department of Defense
Federal
PDMA
WY
CO
AZ
HI
NM
AK
WI
SD
NE
UT
VT
MN
CA
State
21 w/ current laws
14 considering laws
ND
KS
OK
TX
NY
MI
IA
IL
MO
AR
MS
ME
NH
MA
CTRI
PA NJ
OH
DE
WV
VA MD
KY
NC
TN
SC
IN
AL
GA
LA
FL
States with pedigree laws / rules today
States considering pedigree laws / rules
PDMA in effect. No state activity
Manufacturer to Pharmacy
Key
Regulatory
Drivers
Manufacturer to Pharmacy
(Serialization)
Cumulative
Regulatory
Impact
Secondary Wholesalers
(Nationwide)
Secondary Wholesalers
(Florida)
California Express Solution Team
FL
PDMA
CA
NY
Jul‘06
Dec‘06
Jan‘09
Jan‘10
PhRMA Positioning Statement
California BoP, June 2007
Electronic pedigree can be implemented and adds benefits to
secure supply chain.
Item-level serialization adds complexity.
Serialization standards and FDA guidance are needed.
Thus, item-level serialization may not be complete by 1/1/09.
PhRMA recommendations for member companies:
- Start with electronic pedigree
- Take risk-based approach to serialization
California Express Solution Team
California Compliance: A Broad Enterprise Impact
 Business Areas Impacted
• Packaging & Labels
• Packaging Lines and Packaging Execution System (PES)
• Enterprise Applications
o ERP & WMS
o EPCIS infrastructure
o ePedigree application
• Enterprise application and process integration
 How do we meet this challenge in a cost-effective way?
 Where do we start and what is the roadmap?
No single company has expertise on all components and can
represent the complete solution that manufacturers need!
California Express Solution Team
Introducing the
California Express Solution
California Express Solution Team
The California Express Solutions Team
8 Top 20 Manufacturers Work with all 4 Partners Today!
 World’s largest IT provider
 65,000 service professionals in 178 countries
 #1 SAP platform and service provider (15 SAP competency Centers)
 RFID experience as a vendor and a manufacturer
 600+ million products serialized across 35 countries
 75 years of cGMP/QSR-based manufacturing of Printed Packaging
 325 pharmaceutical packaging customers
 ‘Individual Solutions’ strategy founded on trust-based relationships
 Read/write/verify HF/UHF RFID tags, into multiple packaging components
 Produce Item-Level 2D mass serialized bar codes into labels and folding cartons
 Invented ePedigree model and launched 1st ePedigree Application
 70+ Customers representing and 200+ million pedigrees delivered
 Launched 1st EPC Authentication Service (3.5+ million Authentications)
 Serialization Strategy consulting for 10 of Top 30 manufacturers
 20 years experience in pharmaceutical packaging automation
 19 of world’s top 20 pharmaceutical companies
 Thousands of packaging lines in production across 26 countries
 10+ RFID and 2D Item level serialization projects in the industry
 Over 40 systems performing on-line serialization in production
California Express Solution Team
California Express: Solution Overview
Pharmaceutical/Bio Company
Key:
Enterprise
Potentially
Outsourced
Functions
Distribution
Electronic Pedigree Application
Product Flow
Data Flow
Pedigree
ERP
WMS
Serialization
Number
Management
Packaging
Provider
Trading
Partners
Global
EPCIS
Manufacturing
Packaging
Execution System
Packaging Line
California Express Solution Team
Distribution
Nosco
Pre-serialized Packaging
 Nosco offers three mass serialization options integrated into printed packaging
components (item-level labels, case & pallet RFID labels, and folding cartons)
 Mass Serialized 2D Data Matrix bar coding and RFID tags can be written with certification
 2D Data Matrix Managed utilizing a Database Infrastructure - HP Managed Registry
 Manufactured under cGMP and QSR-based procedures in a secure environment
 Can be layered with overt, covert, and forensic authentication technologies
California Express Solution Team
Serialization Options
A Balanced View
Pre-Serialized Packaging
Components
On-Line Serialization
Minimize Packaging Line Set-Up
Maximum Serialization Flexibility
Quicker Time To Market With
Product
No Vendor Data Sharing
Reduced Quality Assurance
Requirements
Reduced Vendor Reliance
No Line Speed Limitations
Less Inventory Management Issues
Less Line Level Capitol
Expenditures
Reduced Risk of Number
Duplication
California Express supports both options.
California Express Solution Team
Systech International
Packaging Execution System




Serving the 19 of world’s top 20 pharmaceutical
companies on thousands of packaging lines
20 years of experience in the packaging automation
business
Focused on addressing the packaging challenges
facing pharmaceutical and highly regulated industry
Leader of emerging Packaging Execution System
(PES) category



California Express Solution Team
Operating in 26 Countries
Offices throughout North America,
Europe and South America
Involved in over 80% of the RFID and
2D Bar Code item level serialization
projects in the industry
Systech International
Packaging Execution System (PES)

Systech introduced the category of PES
• A single system that integrates the critical packaging line information functions: vision
inspection, line management, serialization and performance measurement

Increases speed to market, operational consistency and overall cost-savings

A key component of PES is Systech’s Serialized Product Tracking (SPT);
supplies track and trace serialization at multiple levels (unit, case, pallet)
• Manages the application and verification of serial numbers on RFID tags/bar codes
• Verifies uniqueness of serial numbers, commissions Items, cases and pallets
• Establishes parent-child relationships and stores them in a Secure Database
• Handles packaging events including managing rejects, reworks and QA functions
• Presents data to EPCIS, E-Pedigree, Authentication and Track & Trace

All Systech products are FDA 21 CFR Part 11 compliant
Packaging Execution Systems result in protection, optimization,
and clarity at every level of the packaging environment
California Express Solution Team
SupplyScape
E-Pedigree and Strategy Consulting
Over 70+ companies are protecting 200+ million drug products
today with electronic pedigrees
Pharmaceutical / Biotech
• Brand
• Biotech
• Generic
Wholesale Distributor
•
•
•
•
•
3PLs
Specialty distributors
Repackagers
Medical device kitters
Vet drug distributors
Network Effects
Reaching 50% of Dispensing Endpoints
• Hospitals
• Pharmacies
California Express Solution Team
• Clinics
• Physicians
Pharmacy Chain
• Retail pharmacy chains
• Supermarkets
• Major retailers
California Express and EPCglobal Standards
Current Status of Standards
Existing EPCglobal Standards
CA Requirement
Standards Completed
Electronic Pedigree
Drug Pedigree Messaging Std
• Securely record chain of
ownership
•
•
•
Standard Ratified
CA BoP Accepted
Vendors Certified
Serialization
•
•
•
•
Tag Data Standard (GTIN)
RFID UHF Standard (Gen2)
Barcode Standard (GS1 128)
Data Matrix Standard
• Unique ID number
established by manufacturer
Industry Adoption
70+ trading partners
have adopted
electronic pedigree
Risk-based Approach
Other Initiatives (Track & Trace, etc.)
CA Requirement
None
Standards Phase
Industry Preview
Ratified
Requires
• EPCIS
• Item-level
serialization
• Unified registry
Requirements gathering
• Track & Trace
Not started
• EPC Discovery (Registry)
California Express Solution Team
Project Management & Organization
Coordination of Complete Solution
Project Sponsors / Steering Committee
Business Exec Sponsor, IT Exec Sponsor, HP Sponsor
Core Customer Team
IT Lead
Project
Manager
Supply Chain
Lead
Core California Express
Project Team
Change
Management
Consultant
Packaging /
Labeling SME
Solution
Architect
Manufacturing /
Distribution
SME
Technical
Consultant
Extended Customer Team
Process Owners from Manufacturing (including Line
Operators), Mfg Automation, Distribution,
Compliance, Legal
California Express Solution Team
HP Project
Manager
Business
Process
Consultant
Extended California Express Team
Nosco, SupplyScape & Systech Architects & Engineers
HP California Express Solution Center, Puerto Rico
Implementation Approach
Phase I - Blueprint
Activities
Plan
• Establish
approach &
roadmap
• Document &
assess As-Is
Processes
• Document
requirements
• Develop project
plan
• Develop change
management &
communication
plan
Design
• Develop &
document To-Be
Processes
• Develop technical
architecture
• Develop BOM
• Develop Use
Cases
Phase II – Implementation
Detailed
Design
• Define
integration
specs
• Develop
Configuration
Management
process / plan
• Develop Use
Cases
• Finalize/execute
Procurement
plan
• Develop Test
Scripts
Build
• Develop
interfaces
• Develop
customer user
interfaces where
necessary
• Build
Infrastructure
• Conduct Unit
Test
• Finalize
Configuration
• Develop System
training & system
documentation
Deploy
• Execute
Integration
Testing
• System Testing
• Load Testing
• Execute User
Acceptance
Testing
• Conduct Super
User Training
Close
• Move to
production
• Transition to
support
Deliverables
Monitor & Update CA Board of Pharmacy, applicable laws & regulations
• As-Is Processes
• Project Plan
• Change
management &
communication
plan
• Design Doc
• Technical
architecture
• Use cases
• Hardware &
Software BOM
California Express Solution Team
• Interface Specs
• Configuration
Management
Plan
• Detailed Use
Cases
• Test scripts
• System SW Doc
• System Admin /
Operations Doc
• End-User
Training Manual
• Testing Results
• Test Data &
results
• Go Live
• User Sign-off
California Express Solutions Team
Project Roles & Responsibilities
Business
Strategy
 Serialization Strategy
 Integration with enterprise
business processes
 HP best practices
Process
Definition
and
Optimization
 Serialization Strategy
and legislation;
Federal, State and
International
 Packaging Line
serialization
implications and
capabilities
 Business Process
 Pre-Serialized
Management Methodology Packaging options
and integration
 Change Management
processes
 Serialization Strategy
and legislation;
Federal, State and
International
 Serialization and device
management
Architecture
and Design
 Enterprise Architecture
processes
 Packaging Products
Specifications and
changes
 Focus on SupplyScape  Systech products products
Device and Line Level
to EPCIS
Deployment
and
Integration
Planning
 Project Management
 Systems integration
 Testing
 Samples for Testing
of RFID and 2D on
Labels and Cartons
 Configuration of
ePedigree application
 Serialized Packaging
options for Labels
and Cartons
 Configuration of Use
Cases in Systech
Products
ePedigree + Serialization + Authentication
California Express Solution Team
California Express Solution Center
Working Prototype of End-to-End Solution
Label
Pre-Serialization
California Express Solution Team
RFID Item-level
Serialization
Case-Pallet
Serialization
California Express Example
2-Phase SAP Integration
Pharmaceutical/Bio Company
Key:
Enterprise
Potentially
Outsourced
Functions
Distribution
Electronic Pedigree E-Pedigree
Application
Product Flow
Data Flow
SAP OER
Enterprise
EPCIS
EPCIS
Label
Serialization
Packaging
Services
Pedigree
ERP
WMS
Trading
Partners
Manufacturing
Provider
Guardian
Advisor
California Express Solution Team
Distribution
California Readiness Timeline Example
Sep’07
Jul’08
Jan’08
Strategy & Planning
Complete
Trade Compliance
Jan’09
California
Compliance
Compliance Strategy & Planning
• Procurement cycles
Item
Item Serialization
Serialization
Implementation
Implementation
Case
Case
Serialization
Serialization
Implementation
Implementation
E-Pedigree
E-Pedigree
Implementation;
Implementation;
ERP
ERP integration;
integration;
and
and
Internal
Internal Rollout
Rollout
Case
Case
Interop.
Interop.
Testing
Testing
E-Pedigree
E-Pedigree
Interop.
Interop.
Testing
Testing w/
w/
Trading
Trading
Ptnrs.
Ptnrs.
Serialized
Serialized Cases
Cases
Channel
Channel
Fulfillment
Fulfillment
Pedigreed
Pedigreed Products
Products
Channel
Channel
Fulfillment
Fulfillment
Other Considerations:
 Internal strategy, planning
and budget cycles
 Label development,
…
…
stability testing and
approval
 Constrained Market
Implications
• Packaging Line equipment
…
…
availability
• Key vendor capacity and
scheduling
Government
Government Outreach
Outreach as
as needed
needed for
for clarification
clarification
California
California Express
Express Team
Team Engagement;
Engagement;
Domain
Domain Expertise
Expertise and
and Support
Support
Wholesaler deadlines for ePedigree and serialization
are just 40 weeks away.
California Express Solution Team
A Foundation for Business Value
Visibility Enables Manufacturing and SupplyChain Optimization
Pharmaceutical Industry Opportunities
Product Security
Flexible Manufacturing
(Counterfeits - $ billions)
75
$18b in manufacturing
efficiencies.
65
56
49
44
35
39
‘04 ‘05
‘06
‘07 ‘08 ‘09
‘10
Source: WHO, CMPI
Trade Financials
Source: Gartner
Channel Inventory
(Pharmaceutical Reimbursement)
(Industry Out of Stock Rate)
18%
Chargebacks
Returns
Medicare Rebates
$101B
$33B
2005
8%
80%
2006
Source: HDMA, CMS, IDC
California Express Solution Team
Distributor Out of Stock
Manufacturer Unable to
Ship
Source: HDMA
California Express: Summary
 A complete solution for California ePedigree legislation will impact
many enterprise systems and processes; and no single vendor can
provide everything
 California Express represents the set of market leaders working to
provide an integrated solution and services approach
• The leader in Printed Packaging for Pharmaceuticals
• The leader in Packaging Line Serialization
• The leader in ePedigree
• The leader in IT Systems
 Benefits
• It provides a complete solution; with options for different models, e.g. CMO
• It combines the leading component solutions from the most experienced providers
• It works with your existing enterprise systems and internal resources
• It leverages you enterprise vendors investments in serialization, e.g. SAP
• It is based on EPCglobal standards and will evolve as new standards emerge
• It represents the lowest risk path to California compliance
California Express Solution Team
Further Information & Next Steps
California Express: Regional Workshops




Detail on California Express solution
Discussions with the experts
A detailed understanding of solution options
Upcoming Events
•
•
•

Irvine
Chicago
New Jersey
October 2, 2007
October 9, 2007
October 11, 2007
Register at www.supplyscape.com
Workshop Agenda
09:00
Legislation Update (CA BoP)
09:45
Customer Perspective
10:45
Packaging Options & Packaging Lines
13:00
ePedigree & Enterprise Architecture
Lunch One-on-one discussions
14:00
Implementation Planning
14:30
Value roadmap
15:00
Demonstration and Group Q&A
15:30
One-on-one discussions
California Compliance 1-Day Assessment



Based on Strategy Consulting projects with >10 manufacturers
•
All manufacturer types, structure and sizes
Review your organizations readiness
•
Departmental questionnaires & access to key individuals
Provide top-level readiness plan
California Express Solution Team
California Express Solution Team
Q&A
Graham Clark, SupplyScape
[email protected]
Janine Brown, HP
[email protected]
David DeJean, Systech
[email protected]
Gregg Metcalf, Nosco
[email protected]
Further Information
Workshop:
Register at
www.supplyscape.com
Assessment:
email [email protected]