QAD Explore 2012
Serialization – Business Drivers, Building Blocks
Riya Cao, Vertical Director of Life Sciences, QAD
Guido Van Den Broeck, Senior Product Manager, QAD
Rick Seibert, Vice President, Sharp Corporation
Serialization – Business Drivers, Building Blocks
Safe Harbor Statement
The following is intended to outline QAD’s general
product direction. It is intended for information
purposes only, and may not be incorporated into
any contract. It is not a commitment to deliver
any material, code, functional capabilities, and
should not be relied upon in making purchasing
decisions. The development, release, and timing
of any features or functional capabilities
described for QAD’s products remains at the sole
discretion of QAD.
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Serialization – Business Drivers, Building Blocks
Agenda
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Serialization Status Update
Industry drivers and requirements
Serialization building blocks
QAD solutions
Customer case study
Wrap up
Q and A
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Serialization – Business Drivers, Building Blocks
Overview, Industry Drivers & Requirements
Riya Cao
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Serialization – Business Drivers, Building Blocks
Serialization Overview
Unique identification number
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Serialization – Business Drivers, Building Blocks
Industry Drivers
• Combat counterfeit
- 7% all merchandise globally
- 10% pharmaceutical products globally
• Industry requirement
- Customer requirements
- Regulatory requirements
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Serialization – Business Drivers, Building Blocks
Counterfeit
• Roch cancer
medicine Altuzan
found in U.S.
• Counterfeit hybrid
eXtreme
Uniclamp(TM)
Repair Kits
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Serialization – Business Drivers, Building Blocks
Customer Requirement
• Automotive
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OEM
VIN
Sequencing
MMOG/LE
• Government
contracts
- Defense
- Aerospace
- Component level
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Serialization – Business Drivers, Building Blocks
Customer Requirement
• Consumer products
- Walmart
- Big box retailer
- New vending
• Electronics
- Finished goods
- Components
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Serialization – Business Drivers, Building Blocks
Regulatory Requirements
• Life sciences
- CA ePedigree
- FDA serialization guidance
- International serialization requirement
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Turkey
China
Greece
Italy
Netherlands (proposed)
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Serialization – Business Drivers, Building Blocks
Customer Requirement
• Life sciences
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Wholesalers
Distributors
Hospitals
OEM customers
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Serialization – Business Drivers, Building Blocks
Building Blocks and QAD Solutions
Guido Van den Broeck
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Serialization – Business Drivers, Building Blocks
Serialization for Manufacturers
Operations impacted
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Serialization – Business Drivers, Building Blocks
Serialization - Building Blocks
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Packaging
Serialized data management
Warehouse – serialized inventory
Data carrier (labeling)
Communication and reporting
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Serialization – Business Drivers, Building Blocks
Building Block #1 - Packaging
Unit Serialization (Lot 123)
• Each saleable unit is assigned a
unique identifier
Case Serialization (Lot 123,
24 units per case)
Pallet Serialization (Lot #
123, 128 cases per pallet)
• Units packed into cases. Each
case is assigned a unique
identifier and each unit (child)
is associated with the case
(parent)
• Cases packed onto pallets.
Each pallet is assigned a
unique identifier and each
case (child) is associated with
the pallet (parent)
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Serialization – Business Drivers, Building Blocks
QAD - Packaging Master Data
• Packaging types
• Packaging structures
• Default packaging
structures per item per
origin/destination
• Label Formats
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Serialization – Business Drivers, Building Blocks
Building Block #2 – Serialized Data
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Multiple serial ID formats (GS1, SSCC, SGTIN)
Buyer regulated serial ID ranges
Multi-level aggregation serial ID’s
Identify inventory by serial ID’s and Lot ID’s
Track & trace throughout life cycle serial ID’s
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Serialization – Business Drivers, Building Blocks
QAD – Serialized Data Management
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Serialization – Business Drivers, Building Blocks
Building Block #3 – Serialized Inventory
Warehouse / Distribution
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Serialization – Business Drivers, Building Blocks
QAD - Serialized Inventory Management
• Lot control segregated from
serial control
• Aggregation Serialized Packs
• Integrated with inventory
transactions (Native API’s)
• Packaging transactions
(build, remove, repack…)
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Serialization – Business Drivers, Building Blocks
Building Block #4 – Label Printing
•RFID
•2D Matrix
•Linear
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Serialization – Business Drivers, Building Blocks
QAD - Label Printing Manager
• Setup printers for label printing
• Print barcode labels directly
from key transactions
• Label design using 3rd party
software (label template)
• Label format definitions
• Generate file with fixed and
variable data according to
label format
• Connect to hardware via
different communication
protocols
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Serialization – Business Drivers, Building Blocks
Building Block #5 – Communication, Reporting
Communications, integration and reporting
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Serialization – Business Drivers, Building Blocks
Communication/Integration
• Native API’s
• Q-Docs (QAD
QXtend)
• Serialization logic
integrated in API’s
for inventory
transactions
• Outbound ASN
support serialized
packs / items(RxASN)
• Reporting
Serialization Data
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Serialization – Business Drivers, Building Blocks
Business Flow Example – Item Serialization
Receive sales
order
Pack goods
Load packs in
truck
Receive
authorized ID
ranges
Pick goods
Confirm
shipments
Work order
preparations
Pack move to
warehouse
RxASN
Work order
execution
Pack receipt
by WO
Serial
reporting
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Serialization – Business Drivers, Building Blocks
Sharp Corporation Company Overview & Case Study
Rick Seibert
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Sharp Corporation – Company Overview & Case Study
Sharp Capabilities
Package specialized products
• Oral Solid dose
• Specialized drug delivery
systems
- OTF/TD
• Liquids
• Creams
• Powders
• Ointments
Contract Services / Programs
• Standard Packaging
- Blisters
- Bottles
- Pouches
Compliance Packages
Vial Labeling/Kit Design
Serialization & Track & Trace
Clinical Trial Materials
Packaging
• Specialty Distribution
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- Physician Samples
- Cold Chain
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Sharp Corporation – Company Overview & Case Study
Customer Base
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Sharp Corporation – Company Overview & Case Study
United Drugs Packaging Group
UDPG – ‘International Reach, Local Focus, One voice to the customer’
Sharp Corporation
TD-Packaging
Enestia
European Packaging Centre
Allentown, Pennsylvania
Conshohocken, Pennsylvania
United States
www.sharpcorporation.com
Swindon
UK
www.tdpackaging.co.uk
Hamont-Achel
Belgium
www.enestia.be
Heerenveen,
Oudehaske
The Netherlands
www.epc-pharma.com
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Sharp Corporation – Company Overview & Case Study
US Locations
3 Primary locations in the US
9 Account Executives covering the US
~ 500,000 sq. ft. of packaging space
Approx. $120 million in turnover
Approx. 750 Full Time Employees
Approx. 120 Pharmaceutical Customers
Acquired by United Drug, plc 2008
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Sharp Corporation – Company Overview & Case Study
Packaging
Packaging is becoming a strategic function within the supply chain
Functional
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Protect the drug
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Protect the user – child
resistant (CR), senior
friendly, braille.
Packaging
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Protect the brand and user
through:
Strategic
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Increased compliance
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Reduced diversion
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Reduced counterfeiting
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Reduced reimbursement
fraud
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Sharp Corporation – Company Overview & Case Study
ST&T Services Provided
• Project Consulting and Project Management
- Package and process definition
• Serial number management services
• Data Carrier selection and line integration
- 2D barcodes, RFID Tags
- Pre-serialized carton/tag aggregation services
• ERP integration services
• Flexible solutions custom fit into value added programs
- REMs solutions
- Physician, patient and care giver training and counseling
programs
- Patient registries
- Event based reporting
- Data management and customer interface
• Specialty distribution, cold chain distribution
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Sharp Corporation – Company Overview & Case Study
Technology Partners
• QAD
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QAD EA ™
QAD WMS ™ , QAD TMS ™ , QAD Serialization ™
• Covectra
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AuthentiTrak™ Solution
Saas and on-site system configuration/integration
ERP interface
Serial number management services
Solution development and integration services
• Systech International – Serialized Product Tracking (SPT)™
- Systech Guardian™, Systech Advisor™, Systech Sentri™
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Sharp Corporation – Company Overview & Case Study
Sharp Architecture Serialization
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Sharp Corporation – Company Overview & Case Study
Market Drivers for ST&T Implementation
• Regulatory Compliance
- Federal, State, and International requirements
- PDMA requirements
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Product diversion
REMs Programs
Product counterfeiting, safety
Supply Chain Efficiency
- Returns processing
- Charge-Back authentication, verification
• Compliance and Adherence programs
• Patient, Physician and Care Taker
education/counseling
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Regulation is driving this relationship through serialization
“Use of mass serialization to uniquely identify all drug products
intended for use in the United States is the single most powerful
tool available to secure the US drug supply”
– FDA Counterfeit Drug Task Force 2004
• Pfizer have ear marked €150 million for investment in
serialization in 2012
• AstraZeneca has implemented serialization on 25 packaging
lines in the UK, Sweden and China.
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Sharp Corporation – Company Overview & Case Study
Substance Addiction
“A Case for Integrated Solutions”
• The Key Stakeholders
- PharmaCo – Our
“Customer”
- The Patient
- The Clinician
- The Payer/PBM (Pharmacy
Benefits Managers)
- Regulatory Agencies
• The FDA
• The DEA
Sharp Corporation – Company Overview & Case Study
Customer Challenges
• Losing patent protection/exclusivity on the
existing formulation
- Pending generic entry
• Launching a new formulation which
changes prescribing habits
• Different product requirements for US and
ROW
• Limited physician demographics (training
and monitoring)
• Regulatory approval risks – REMs, delays,
etc.
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Sharp Corporation – Company Overview & Case Study
Patient Challenges
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Withdrawal
Confidentiality – “stigma”
Isolation
Disease state itself
Need for information and access
Convenience
Education
Cost
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Sharp Corporation – Company Overview & Case Study
Clinician Challenges
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Training
Practice Management
Technology access
Clinical support – clinical outcomes
Patient base monitoring
Certification - regulation
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Sharp Corporation – Company Overview & Case Study
Payer/PBM Challenges
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Clinical endpoint?
Efficacy
Availability
Compliance and Adherence
Control of supply chain
Therapeutic choices
- Efficacy
• Diversion
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Sharp Corporation – Company Overview & Case Study
Regulatory Agency Challenges
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Drug Diversion and Black Market
Patient Safety
Community Safety/Child Safety
Crime
Monitoring
Physician accounting
REMs
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Sharp Corporation – Company Overview & Case Study
Integrated Multi-Channel Strategy
Multi-Channel Compliance Solution
16 years experience
designing compliance and
persistency programs
In-Out bound support
HCP/ Patient Educational Programs
Tele-Services
COLLABORATION
Nurse
Educators
Select Targets & Deciles
HCPs & Patients
‘Total Office Call’
Multi-Channel Compliance
Technologies
Synergy with Sales Force
Fulfillment Department for
Direct mail solutions
Packaging
Engaging Patients
Design
Informing Patients
Guiding Patients
By Design
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Serialization – Business Drivers, Building Blocks
Wrap-Up
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Serialization – Business Drivers, Building Blocks
Business Values Serialization
• Meeting Regulatory Requirements
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Compliancy California ePedigree Act (2015)
Similar requirements other countries
• Enhanced product Safety and Integrity
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Increased granularity in tracking and tracing
inventory
Speed Up and reduced cost of product recall
process
Detect and eliminate counterfeiting
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Serialization – Business Drivers, Building Blocks
Business Values Serialization
• Opportunity for Business Value
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Compliancy Customer Requirements
Branding & customer Loyalty
Explore New Markets
• Improving Business Operations
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Accuracy Inventory / Order Fullfilment / Shipping
Performance
Increased Inventory Visibility accross Supply Chain
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Serialization – Business Drivers, Building Blocks
QAD Serialization Summary
Packaging
QAD
Serialization
Serialized Data Management
QAD
Serialization
Data Carriers/ Label Printing
QAD
Serialization
Serialized Inventory (Transactions)
QAD
Serialization
Communications / Integration
QAD
Serialization
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Serialization – Business Drivers, Building Blocks
Serialization+ Solution Timeline
Generally Available
Early Adopter
Jul
Aug
2012
Sep
Oct
Nov
Dec
Jan
Feb
Mar
Apr
May
Jun
Jul
Aug
Sep
Oct
Nov
2013
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Serialization – Business Drivers, Building Blocks
Next Steps
• Demo Theater
- Demo Session @ Demo Theater
Tuesday @ 7 PM
• Expo QAD Booth
• Engage with your QAD account manager
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Serialization – Business Drivers, Building Blocks
Questions & Answers
Riya Cao
Vertical Director of Life Sciences, QAD
zrc@qad.com
Guido Van den Broeck
Senior Product Manager, QAD
gvb@qad.com
Rick Seibert
Vice President, Sharp Corporation
rick.seibert@sharpcorporation.com
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www.qad.com
© QAD Inc 2012
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