Serialization for 3PLs - WDSrx...Supply Chain Management Software & Solutions IoT & Digital Supply...
Transcript of Serialization for 3PLs - WDSrx...Supply Chain Management Software & Solutions IoT & Digital Supply...
A Glimpse Into The Post-Implementation Future of Serialization
(Cases from Europe and the U.S.)
Evren Ozkaya, Ph.D., Founder and CEO at Supply Chain Wizard, LLC
Lawrence Hotz, Marketing Manager at WDSrx – Woodfield Distribution, LLC
Serialization for 3PLs
Agenda
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DIGITAL SUPPLY CHAIN TRENDS
USA – SERIALIZATOIN FOR 3PLs
INTRODUCTIONS: SCW & WDSrx
Quick introduction of presenters & their companies
Technology and Business Trends in Life Sciences
EUROPE – 3PL SERIALIZATION CASE STUDY
VALUE BEYOND COMPLIANCE
Experience from the largest Pharma 3PL in Turkey – Ekol Logistics
WDSrx compliance journey
What comes after the deadlines? How to manage operational efficiency.
Introductions
• WDSrx Provides Third Party Logistics Services And Value Added Solutions Empowering The Life Sciences Industry
• DSCSA Compliant Warehousing, Fulfillment, Packaging and Labeling
• U.S. And International Clients
• Primarily Mid-Size Generics Manufacturers
• Client Base Includes Rx, OTC, Veterinary, Supplements And Nutraceuticals
• On A Typical Day Our Headquarters Facility In Boca Raton, FL Packs 14 Million Dosages Into 800 Orders Reaching 530 Zip Codes And Traveling Over 1.6 Million Kilometers
Woodfield Distribution, LLC – Overview
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Serialization
(Track & Trace)
Consulting
Supply Chain
Management
Software & Solutions
IoT & Digital
Supply Chain
Transformation
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• Track operational activities live w/ IoT
• Enhance serialization data for ROI
• Facilitate Trade Partner Collaboration
• Build a “learning” digital supply chain
• Increase the speed of digital transformation
Digital Supply Chain Trends
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Track and Trace /
Digital Infrastructure
Industry 4.0 &
Internet of Things (IoT)
• Serialization regulations
• Serialization systems
• IT connectivity
• Unit level traceability
• IoT Sensors
• Connectivity of Things (equip., people, products)
• Real-Time Tracking
Business Intelligence & Advanced Analytics
• Big Data Solutions
• Analytics-as-a-Service
• Machine Learning
• Automated Controls
Te
ch
no
log
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End-to-End Collaboration
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Granular Supply Chain Visibility
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Data Driven Decision Making
• Intercompany visibility
• End-to-end SC visibility
• Unit-level Asset / Product / Labor Monitor & Planning
• Supplier Collaboration
• Customer Collaboration
• End-to-End Supply Chain Collaboration
• Patient/Consumer Insights
• Advanced Planning
• Pricing / Commercial / Operations Strategy
Bu
sin
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Right Product Right Quantity Right Time Right Quality Right Price
SC Mission
Supply Chain
Pharma / CMO
Supply Chain
• Make-to-order • Order size 1 • 3-7 minutes
• Transparency
• Feedback
• Reviews / KPIs
• Half-price vs. Taxi
• Variable cost structure
• Abundant Supply that is outsourced
• Make-to-order • Order size = Batch size
• ~90-120 days • High % QA holds
• Low Service Level
• No Customer Feedback KPI
• Limited outsourcing
• High fixed cost
• High prices
• Low Efficiency
Europe – 3PL Serialization Case Study
Ekol Logistics - Overview
Ekol Healthcare in Turkey
30%
Turkish Track & Trace Journey – Early Days
Track & Trace Journey – System & Data
Track & Trace Journey – Integration
Track & Trace Journey – Process Improvements
Track & Trace Journey – 5 years after go-live
2017:
Partnered with Supply Chain Wizard to bring
Serialization-as-a-Service Hub service in EU
Track & Trace Journey – Key Challenges for 3PLs
Track & Trace Journey – Key Benefits for 3PLs
USA – Serialization for 3PLs
Serialization Viewpoints
• The DSCSA Was Passed Into Law By President Obama In 2013
• At That Time, WDSrx Made The Decision To Invest Significant Resources For Early Compliance Implementation Despite Vague Requirements
• Strategic Benefits Of That Decision: Early Industry Influencer, Client Guidance, Streamlined Onboarding, Multiple Entry Points
Jumping In The Deep End
• Partners: TraceLink, ROC IT Solutions, Optel Vision
• Implementation in Q3 2017
• Receiving Serialized Product
• Reaching Out To Clients And Potential Customers And Advocating For A Comprehensive Serialization Program
• Vague Language; Wholesaler Requirements; CMO/Brand Owner Labeling
• Major Wholesalers Are Working With Big Pharma Because They Have Leverage
• Our Smaller Clients Are Vulnerable Because They Lack Volume
Current Outreach and Feedback
We spoke with a client who is a virtual manufacturer
• According to their CMO, their product was serialized because they were adding unique serial numbers to each package
• We explained serial numbers are only one component of serialization
• Brand owner forfeits some ownership control if serial numbers generated from another party repository
• We are battling the ambiguity in the Act and the confusion it is causing
• Product flow and information flow follow different pathways
• Our client dialogue is in two phases: 1. Understanding, leading to 2. Appreciation
Case Study
We Offer Solutions For Manufacturers That Don’t Plan To Serialize And For Others That Have Item Serialization
• Establish Level 4 Repository On Behalf Of Client And Under Their Control
• Packaging And Labeling With DSCSA-Compliant Labels And Barcodes On Each Unit And Package And Pallet
• Store And Fulfill
• Ability To Transmit Aggregated Serialized Data Back To Client To Send Downstream – Information Flow Different From Product Flow
• For Distribution, Managing Data Transmission Of Serialized Data Between Customer And Trading Partner
Serialization Solutions Today
Serialization Solutions For European Manufacturers
• European Manufacturers With Multiple U.S. CMOs
• WDSrx Can Serialize Products From Their Non-Compliant CMOs
• We Are Capable Of Adhering To EU Requirements Through TraceLink To Ship Compliant Products To Europe For Their Market
• Serialization Implementation And Services Affect Warehouse Performance Metrics –Supply Chain Wizard
For European Brand Owners
Value Beyond Compliance – Digital Warehouse
Joint Value Creation in 3PL Operations
• Achieve transformational
impact in the way 3PLs operate
• Inter-Organizational Insights and Best Practices sharing
• Proactive approach to addressing
serialization efficiency impact
• Advanced analytics platform leveraging data & optimizationabilities
Operational Efficiency
Industry Leadership
ImpactCollaboration
Technology is modular, flexible and easy to integrate into all known IoT Platforms. Designed for Industry 4.0 to transform Supply Chains.
SensorsMore than 60 sensors
• Temperature
• Humidity
• Accelerometer
• GPS Location
• Pressure
• Light
GatewaysDifferent connection types
• GSM GW
• WiFi GW
• Ethernet GW
• InCar GW
• Smart Phone App GW
• Lora GW
• SigFox GW
TriggersMechanical needs
• Button
• Touch
• Contact Switch
• Read Switch
• Mechanic Switch
PlatformsCompatible IoT Platforms
• Microsoft Azure IoT Suite
• SAP Hana
• ThingWorx
• Axeda
• IBM BlueMix
• AWS IoT
R&D
Consultancy
Electronic Device
Manufacturing
Mobile
Applications
Software
Development
Big Data Analytics
Payment Systems
Vertical IoT Platforms
Industrial IoT
Tailor Made
Projects
Smart City
Solutions
Vehicle Telematics
Smart Grid
Data CenterWhite Label
Manufacturing
LIVE & Historical Dashboards
SCW DIGITAL WAREHOUSE DASHBOARDS REPORTS SETTINGS ozkayae
OVERVIEW: Track Labor in real time to see current status of workers; monitor actual labor cost in operations
Live Staff Locations Spaghetti Diagrams Heatmaps
(Illustrative only)
Read more at:
http://www.pharmamanufacturing.com/articles/2017/pharmas-digital-supply-chain-transformation/
DASHBOARD
Focus: Turning data into insights, visualizing what’s not visible before (patterns, trends…etc.)
Technology: Data visualization tools, charts, statistics
Example Applications:
• OEE Tracker
• Management Dashboard
• Labor Tracker
DECISIONS
Focus: Turning insights into strategic, tactical and operational decisions to improve performance
Technology: Operations Research, Smart Algorithms, Heuristics, Machine Learning
Example Applications:
• Serialization Wizard
• [Line & Staff] Scheduler
DATA
Focus: Collecting, organizing data on supply chain components at unit level (products, people, processes)
Technology: T&T systems, IoTsensors, Surveys, HMIs, Databases
Example Applications:
• Supply Chain Portal
• Serialization Survey
• Regulations Database
• Digital Logbook
Track & Trace Compliance