Transcript Presentation

Preparing Your IT Infrastructure, Internal
Operations and Supply Network for
Track and Trace Regulations
ISPE Professional Development Day
New Brunswick, NJ
Agenda and Speaker
Agenda
 Global Track and Trace Requirements, Challenges and
Strategies
 Master Data Impacts of Serialization and Track and Trace
 Business Process Touch Points and Layering
Serialization Over Operations
 Network Integration and Data Exchange Considerations
 Pulling It All Together: China Case Study
 Global Track and Trace Solution Capabilities and
Preparation Checklist
 Q&A
2
© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
Speaker
Brian Daleiden
Vice President
Marketing
TraceLink
Global Track and Trace Requirements,
Challenges and Strategy Development
ISPE Professional Development Day
New Brunswick, NJ
Key Global Track and Trace Requirement Themes
Generate, Acquire and
Manage Serial Numbers
SC Partners
Gov’t Agencies
Exchange Track and Trace
Information
SC Partners
Gov’t Agencies
Verify Serial Numbers and
Transactions
SC Partners
Gov’t Agencies
Report on Products and
Transactions
Gov’t Agencies
 When is track and trace information required to be exchanged?
-
Product Manufactured / Serialized
Product Imported, Exported
Product Sales / Distributions, Product Receipt, Product Returned, Product Destruction, etc.
Product Movements
 What kind of track and trace information is required to be exchanged?
- Event date, serial numbers, product code (e.g., GTIN, country registration code), lot number, expiration date
- Seller, buyer, transaction ids (e.g., PO, delivery document, invoice)
 Who is required to supply and/or exchange track and trace information?
- Pharma companies, CMO/CPOs, Repackagers, Kitters, 3PLs
- Returns Processors, Wholesale Distributors, Pharmacies/Clinics
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© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
Building the Global Track and Trace Analysis
Chart (selective 5 country example)
Requirement
US
China
Argentina
Brazil
Turkey
Manufacturer
Government
Manufacturer
Manufacturer
Manufacturer
GS1 Standard
20 digit custom
GS1 Standard
13 digit custom
GS1 Standard
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Rx, Phased
Rx, All
Serialization
Serial Number Creator
Serial Number Format
(SNI in SGTIN format)
Randomization
Aggregation
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
Rx, All
Rx, Phased
Products
Product Scope (not incl. certain product type exceptions)
Rx, Phased
Supply Chain Transaction Tracking / Government Event Reporting
Product Manufactured
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Serial Number Replaced

Product Imported
Product Sales / Distribution
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Product Transfer
Product Donation / Samples
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Product Exported
Product Receipt from Purchase
Product Return Distribution
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Product Return Receipt
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Product Restocked
Product Quarantined
Product Withdrawn / Recalled
Product Expired
5
Product Damaged / Product Destroyed / Serial Number
Deactivation
Product Stolen / Lost
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Product Sampled (quality)
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© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
Product Verification Query
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Global Track & Trace Challenges
Global Track & Trace compliance requires organizations to think differently about their
supply chain networks, business processes and IT architectures
Global Supply
Network
Integration
Big Data
• Challenge: Integration of 100s of supply chain partners for track & trace
messaging and compliance
• Strategy: Network Approach
• Challenge: Terabytes of data and 100,000s of transactions cannot be
managed through traditional enterprise architectures
• Strategy: Native Cloud Architecture
Changing
Standards and
Regulations
Strategic Value
• Challenge: Regulations and standards are continuously evolving and will
continue to evolve for the foreseeable future.
• Strategy: Multi-tenant and Validated
• Challenge: Drive strategic business value from track & trace compliance
investments
• Strategy: Extensible Solution Platform
6
© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
Global Track & Trace Challenges
Global Track & Trace compliance requires organizations to think differently about their
supply chain networks, business processes and IT architectures
7
Global Supply
Network
Integration
• Integration of 10s to 1000s of supply chain partners for track & trace
messaging and compliance
Big Data
• Terabytes of data and 10,000s to 1,000,000s of transactions cannot
be managed through traditional enterprise architectures
Changing
Standards and
Regulations
• Regulations and standards are continuously evolving and will
continue to evolve for the foreseeable future
Strategic Value
• Track and trace compliance is a huge investment, yet sets the stage
for developing strategic business value through better information
and supply chain visibility
© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
Aligning Global Requirements to Business
Strategy and Operational Procedures
 Business Strategy Survey
Strategic Elements
Operational Goals
Ensure regulatory compliance for existing, new markets
Flexibility (meeting diverse requirements)
Operational extensibility for future regulations
Agility (meeting unanticipated regulations)
IT architecture extensibility for future regulations
Global standardization vs. local deployment
Deployment repeatability and scalability
Responsiveness (data updates, user/system access)
New product launch integration
Cost effectiveness
 Operational Planning Analysis
- Analyze overall network for required operational event capture
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
Manufacturing and packaging lines (internal, CMO/CPOs)
Finished goods warehouses in manufacturing network
Distribution network (3PLs, distribution partners, importers/agents, dispensation points)
Government agencies
- Identify business process requirements to meet and maintain compliance
 Standard business processes (sales/shipment, purchase/receiving, returns, special processes like drop shipment)
 Exception handling
- Define Operations Requirement Flows
 Operationally “agnostic” to mandates
 Minimize operations impacts and change management burden
 Automated and/or manual compliance activities
8
© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
Impacts of Serialization and Track and
Trace on Master Data
ISPE Professional Development Day
New Brunswick, NJ
Considerations for Developing a Track and
Trace Master Data Management Strategy
Existing Master Data
 What Master Data do I already have?
- Product MD: GTIN, Country Drug Code (US - NDC, Germany - PZN)
- Customer MD: Business name and address
 What systems does the current Master Data reside in?
- ERP, SCM/warehouse management, CMO/CPO systems, local country partner systems
 What is your strategy for making the Master Data available to the track and trace systems
New Master Data
 What new Master Data is required for global track and trace?
- Product MD: China – 3 levels of product identifier (product code, subtype code, resource code), new product attributes
such as Code Version, Code Level and Packaging Ratio
- Customer MD: Country-specific company identifiers (e.g. Brazil – CNPJ, Argentina – CUIT, GLN)
- Partner/Channel MD: Brazil - Company identifiers, business name and address for carriers
 As the company serializes to meet new country mandates, how do I identify and collect new Master Data?
 In what systems will this new track and trace Master Data be maintained?
 What are the supporting track and trace systems that will be the consumers of the Master Data and which
classes of Master Data is required for each?
- Packaging line systems
- Serialization management systems
- Regulatory compliance and reporting systems
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© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
Business Process Touch Points and
Laying Serialization over Operations
ISPE Professional Development Day
New Brunswick, NJ
Determine Strategy for Layering Serialization and Event
Tracking Over Logistics Processes
“Over the Top” Approach
Fully Integrated Approach
Serialization
Repository
A
B
Serialization
Repository
C
Internal Distribution Network
Scan / update on every internal product
movement or change in form
A
B
C
Internal Distribution Network
Scan / update on receipt into network, shipment to
customers and aggregation changes
 Determine depth of operational integration
- Regulatory-driven, Operationally-driven, both
 Determine which business processes and operational systems need to be “serialized inventory aware”
- WMS, Inventory Management, Shipping / Receiving, etc.
 Determine which regulations and processes impact the state of data in the serialization repository
- E.g. Aggregation, Brazil movement tracking, etc.
 Minimize change management and errors by postponing updates and eliminating touch points
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© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
Develop Detailed Business Process Mapping to Define the
Touch Points for Required Events and Data Updates
 Tracking product movements throughout production, internal warehousing and across your supply chain
(CMP/CPO sites, 3PL sites, wholesale distributor facilities, etc.)
- Production: Packaging Functions, Re-Work Functions, Inventory Functions
- Inventory and Distribution: Pick, Pack and Ship Functions, Receiving and Put Away Functions
- Exception Management: Shipping Errors, Product Damage, etc.
Track & Trace Compliance: Physical Product Flow vs. Serial Number Life Cycle
Packaging
Warehousing / Distribution
Product
Received / Put
Away
Serial Number Life Cycle
Product Process Flow
Product is
Serialized
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Returns Processor
Internal Transfer
Product
Released
Shipment Order
No
Aggregation
Customer
Aggregation
Aggregation
Aggregated
SALE /
Transfer?
Transfer
Sale
Pick & Pack
Post Goods Issue
(PGI)
Customer
Receives the
Shipment
Customer
Returns Item(s)
Returns Process
or Receives
Product and
Destroys It
Picked
Shipped
(Transfer or Sale)
Received
Returned
Return Received
Commissioned
Available
Dis-Aggregate /
Re-Aggregate
Destroyed
Reserved
and State Changes
PhysicalReserved.
Product
Serial NumberProgram – MarchMovement
© 2014 TraceLink Inc. All Rights
ISPE Serialization
20, 2014
Not Required for Track & Trace
Movement
Life Cycles
Physical Movement Requiring
Serial Number Change
Physical Movement Optional
Serial Number Change
Define and Manage Regulatory Reporting Triggers on
Key Operational Events
Event
Serialized Product Attribute
Regulatory Reporting Action
Product Release
Item Code, Market (Country)
China – RelationCreate Report
Turkey – Production (Uretim) Notification
EU Countries – EFPIA Report
Product Commissioned
Item Code, Lot, Market (Country)
China – RelationCreate Report
Turkey – Production (Uretim) Notification
Sales Distribution
Ship To Country
China – RelationCreate Report
Turkey – Production (Uretim) Notification
EU Countries – EFPIA Report (All Ser # in Lot)
Brazil: - TBD
China – SalesWareHouseOut Report
Turkey – Sales (UreticiSatis) Notification
Argentina – Distribution Notification
Turkey – Export (Ihracat) Notification
India – Future
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Return Receipt
Ship To Country
Destruction / Decommission
Country
© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
China – ReturnWareHouseIn Report
Turkey – Return Receipt Notification
Argentina – Return Received Notification, Restocked
Brazil – TBD
Turkey – Importation Notification
China – Code Deactivation Report
Turkey – Deactivation (Deaktivasyon) Notification
Argentina – Damaged/Destroyed Notification
Brazil – TBD
Network Integration and Data Exchange
Preparation
ISPE Professional Development Day
New Brunswick, NJ
Identify Where Events Occur in Your Network
Potential Key Touch Points By Market Required for Network Data Exchange
CMOs / CPOs
Events
Commission, Aggregation, Ship
Return, Return Receipt
Destruction
Serial Number Exchange
Serial Number Request
Serial Number Response
Serial Number Disposition
Events
Commission, Aggregation
Ship
Government
Agencies
Government Reports
Product Manufactured
Product Imported
Product Exported
Product Sales / Distribution
Product Receipt
Product Returned
Product Return Receipt
Product Restocked
Product Quarantined
Product Expired
Product Withdrawn / Recalled
Product Damaged / Destroyed
Product Stolen / Lost
Government Queries
Request for Information
Product/Transaction Verification
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© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
Events
Return
Return Receipt
Destruction / Decommission
Pharma /
Biopharma
Companies
Logistics Service
Providers
Returns
Processors
Change of Ownership, Movement
Ship (w/ Commission, Aggregation)
Sale / Purchase
Return / Return Receipt
Pharmaceutical
Companies
Change of Ownership, Movement
Ship (w/ Commission, Aggregation)
Sale / Purchase
Return / Return Receipt
Wholesale
Distributors
Change of Ownership, Movement
Ship (w/ Commission, Aggregation)
Return
Return Receipt
Pharmacies /
Hospitals
Identify Network Data Exchange Complexity
US DQSA Example for Pharmaceutical Company
Purchase
Shipment
Pharmaceutical
Companies
CMO/CPOs
3PLs
Repackagers
EPCIS
eASN
??
PDF
Aggregation
Serialization Data
Aggregation Events
Repository
 Diverse data exchange methods
Product
Production
Serialization
Aggregation
 Multiple data sources
 Data archival complexities
??
Packaging Sites
CMO/CPOs
 Data format translation issues
© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
EPCIS
Wholesale
Distributors
eASN
Dispensers
PORTAL
Serialization Data
Aggregation Events
Pharmaceutical Company
 Multiple network connections
Pharmaceutical
Companies
Transaction History
Transaction Information
Transaction Statement
Shipment
Transaction History
Transaction Information
Transaction Statement
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Sale
Production
Transaction History
Transaction Information
Transaction Statement
Government Officials
??
Investigation
Build Network Partner Prioritization Framework
 Create a “Network Profile” to identify and classify supply and network partners
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Network Density
Integration Status
Strategic Importance and Volume
Other?
 Rank order partners for deployment planning
Wave 1
Wave 2
Wave 3
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© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
• High Network Density
• Pre-Integrated Partners
• Strategic Partners
• Medium Network Density
• Partners Requiring Integration
• Medium Volume Partners
• Low Network Density
• No or Difficult
Integration
• Low Volume Partners
Create a Partner Network Heat Map
Build a Heat Map to Review and Monitor Network Deployment
 Partner Information
- Partner Type (CMO, WHS, 3PL, etc.)
- Partner Name
- Partner Location
 Strategic Importance
- Tier 1, 2, 3
- Averaged across Customers
 Customers Serviced
- Currently a customer partner
- Expected customer partner (ie, Product Launch)
 Current Integration Status
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© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
Currently Integrated
Integration in process
Integration pending
No integration currently planned
Pulling it All Together
China Track and Trace Compliance
Case Study
ISPE Professional Development Day
New Brunswick, NJ
China Serialization, Tracking and Reporting Model
China
CFDA Database
Patients
Pharmaceutical
Company
Wholesale
Distributor
Pharmacies /
Hospitals
Data Exchanges
Product Registration and Serial Number Acquisition
Government Reports
Packaging Site
CMO / CPO
Government System Queries
Business and Serialization Data Exchange
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© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
Manufacturer Summary Requirements
 Registration and Product Master Data Configuration
- Companies complete network registration form and submit to China CFDA
- Receive Digital Certificate from China CFDA to use for Product Master Data Updates, Serial Number Acquisition and
Government Report uploads
- Configure and maintain Product Master Data
 Serial Number Acquisition
- Download China serial numbers (EDMC codes) to support products packaged at internal and external packaging sites
 Serial Number Application
- Apply acquired serial numbers across all levels of sales packaging
- Develop and maintain aggregation relationships across serialization hierarchy
 China Government Reports
-
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Commissioning / Aggregation
Sales
Return Receipts
Serial Number Deactivation
Others (Receipt of purchased product, return of purchased product, transfers…)
© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
China Reporting Requirements
Potential Transaction Triggers for Government Reports Depending on Product Manufacture
Location and Distribution Channel
Transaction
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Manufacturer
3PL
Wholesaler
Retailer
Activation from production
√
Goods receiving from production
√
√
Goods receiving from procurement
√
√
√
√
Goods receiving from goods transfer
√
√
√
√
Goods receiving from returned goods
√
√
√
√
Goods dispatching for sales
√
√
√
√
Goods dispatching for goods transfer
√
√
√
√
Goods dispatching for returned goods
√
√
√
√
Goods dispatching for disposal
√
√
√
√
Goods dispatching for sampling
√
√
√
√
Replacement of drug surveillance code
√
√
√
√
Write-off of drug surveillance code
√
√
√
√
© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
Registration and Product Master Data
Configuration
 Manufacturers maintain product master data with China system using CFDA Application
 Product Information
-
Product Code (Identifies the drug product)
Product Name
Product Sub-type Code (Sub-node of product code distinguishing different package specifications of a drug)
Approval Document Number
Preparation Type (e.g., Tablet)
Preparation Specification (e.g., 30 mg)
Package Spec (e.g., 10 vials per carton)
Physical Detail Classification Type: (e.g., 1=raw materials of stupefacient, 8=vaccine, etc.)
Package Unit
 List of Product Resource Codes for the Sub-type Number that will receive EDMC codes
24
Resource Code
Code Version (Product code version number (e.g., 81, 88)
Package Code Level (e.g., 1, 2)
Cascade Package Ratio (e.g., 1:10:50)
© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
China Serial Number Acquisition and Format
 Manufacturers download EDMC codes for each packaging level of the product using the CFDA
Application
-
EDMC serialization code file exported from China application for drugs in the China drug catalog
Text file includes header information including Resource Code and Product Sub-type Code
Followed by list of EDMC serialization codes
Be aware that there are slight file header differences for EDL vs. non-EDL drugs
 China EDMC Code is a 20 digit number with four distinct segments
- Product Code: Drug name, dosage form, approval number, packaging specifications
 Code Version (codeVersion): Product code version number that identifies pack level (e.g., 88=carton, etc)
 Resource Code (resCode): Identifies the product and associated drug name, dosage form, approval number
- Serial Number: Sequential serial number associated with the product identified in the Resource Code
- Check Digits: 4 random digits that make it difficult to guess the serial number assigned to the package
 Example: 81000210157090217447
-
25
81 = Product code version Number that identifies the pack level [ Position 1 to 2 ]
00021 = Resource code that identifies the product [ Position 3 through 7 ]
015709021 = Serial Number [ Position 8 through 16]
7447 = Check Digits [ Position 17 through 20 ]
© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
China EDMC Code Application
 The EDMC Code is applied to all levels of sales packaging
- Saleable units, bundles and cases
- Pallets do not receive an EDMC code
 Aggregation relationships for all levels of packaging must be maintained and included in China
government reporting
 The 20 digit EDMC code is encoded on product packaging using a Code 128C one-dimensional
/ linear barcode
- Can be directly printed on packaging or applied via sticker
Style A
Style B
Style C
With horizontal orientation of phone, SMS and website for verification
With vertical orientation of
phone, SMS and website for
verification
26
© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
China Transaction and Reporting Sequencing
Potential pharmaceutical company scenario
China CFDA Database
Information Flow
Physical Flow
1
China CFDA Serial
Number Retrieval
Shipment SalesWarehouseOut
Commission RelationCreate
Decommission –
Code Deactivation
CFDA Serial Numbers
4
Commission & Aggregation
Pharmaceutical
Company
Packaging Site
Activity
27
(* optional)
6
5
3
2
Return Receipt –
ReturnWarehouseIn
PharmaCo
Warehouse
Wholesale
Distributor
Description
1
Retrieve China Serial Numbers
Serial numbers must be manually retrieved by an authorized agent of the Pharmaceutical company
2
Serial Number Exchange
Share serial numbers with internal and / or external packaging sites and receive commission / aggregation info
3
Commission – RelationCreate
Report commissioning and aggregation information to CFDA. This typically done after Batch Release.
4
Decommission – Code Deactivation
Any serial numbers sampled, destroyed or removed from distribution must be reported to CFDA
5
Shipment – SalesWarehouseOut
Upon shipment from PharmaCo, the Shipment – SalesWarehouseOut Report is generated and submitted.
6
Return Receipt – ReturnWarehouseIn
Upon returns to the PharmaCo, the Return Receipt – ReturnWarehouseIn Report must be generated and submitted.
*
Shipment – SalesWarehouseIn
Upon shipment receipt at the PharmaCo, the Shipment – SalesWarehouseIn Report is generated and submitted
* © 2014
Return
– ReturnWarehouseOut
Upon return from the PharmaCo, the Return – ReturnWarehouseOut is generated and submitted
TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
China Solution Business Process Map
PharmaCo
HQ
PharmaCo
Compliance
Team
PharmaCo
Serialized
Operations
PharmaCo
Serialization
Contract
Packager
Product Activation Report to CFDA
28
© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
Global Track and Trace Solution
Requirements and Readiness Checklist
ISPE Professional Development Day
New Brunswick, NJ
Global Track & Trace Solution Capabilities
Serialization
Operations
Compliance
Capabilities Mixed/Matched Based on Regulations and Ecosystem
30
Government Reporting
Supply Chain Track and Trace
 Automated, harmonized creation of gov’t reports
 Change of ownership tracing across supply chain
 Flexibility for integrated submission or manual upload
 Product movement and transaction tracking
 Exception management and pre-submission testing
 Track and trace at lot and serialized level
 Support for unique file and transmission requirements
 Verification of product identity status
Serialized Operations Management
 Extensible EPCIS repository
 Full end-to-end aggregation management (internal,
external)
 Strict and loose “over-the-top” tracking options
Serial Number Management
 Warehouse & Logistics interfaces (Pick, Pack, Post Goods
Issue, Shipment, Sample, etc.)
 Flexible triggering for tracking, tracing, verification and
government reporting activities
Serial Number Exchange
 Creation, import and management of serial numbers
across standard GS1 and custom formats
 Automated replenishment and SN allocation
 Flexible support for serial number ranges and lists
 Integration flexibility to multiple line management
systems and external supply partners
 Random, sequential and uniqueness options
© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
 Global SN allocation and usage monitoring
Checklist for Preparation of Business and
Supply Network Compliance Plan
Internal Business




Determine the full scope of your current business operating ecosystem (buy, sell, drop ship, transfer, repackage, dispense)
Identify business process touch points and systems which trigger compliance activities (sale, shipment, receiving, etc.)
Identify business systems where required product, production, transaction, partner and shipment information resides
Determine OPTIONAL data potentially beneficial to capture or share for operational efficiency or business performance
 Product expiry, invoice/PO number, etc.
 Analyze exception points and identify required SOPs for exception management
 Analyze change management risk (frequency of product change, operational change (new businesses, locations))
Supply Network
 Compile list of all downstream supply chain trading partners to whom you sell drug product or drop-ship product
 Company information, license information, key contacts
 Compile list of packaging sites and contract partners that produce saleable product
 Products produced, markets served, serialization/packaging technologies
 Determine if the market you serve requires potential communication with indirect trading partners
 Compile list of all upstream supply chain trading partners from whom you buy saleable drug product
 Identify the status of the drug products that you acquire
 Originally manufactured, purchased from direct source, purchased from indirect source, repackaged
 Determine internal capabilities and preferences for exchange of compliance data with external partners
 Survey trading partners to determine their capabilities or preferences for providing or receiving compliance data
 Analyze change management risk (frequency of partner change, B2B change, new market introduction, etc.)
31
© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
TraceLink
Dedicated to Building Global Life Science Solutions
TraceLink Life
Sciences Cloud
•
•
•
•
Secure, extensible Amazon AWS Cloud-based global network platform
Serialization support across the end-to-end serial number lifecycle from packaging line to patient
Integrated government reporting for report generation, submission and archival
Network partner and subscriber connectivity, configuration and management administration platform
Infrastructure and • Fully outsourced IT infrastructure, data storage and user management in elastic, native cloud environment
• Audited platform that is designed for pharma security considerations and validated across each software release
Software
• Redundant, Active-Active environment to support disaster recovery and high availability
Management
Network
Management
Services
• Rapidly expanding network of suppliers and trading partners already on the network for point-and-click connection
• Completely outsourced partner on-boarding, integration and management services
Cloud Community
• Active community of customers sharing regulatory insight, operational best practices and IT architecture learnings
and Knowledge • Diligent monitoring of US/global regulations and active leadership in GS1 standards development
Resources
32
www.tracelink.com
© 2014 TraceLink Inc. All Rights Reserved. ISPE Serialization Program – March 20, 2014
Preparing Your IT Infrastructure, Internal
Operations and Supply Network for
Track and Trace Regulations
ISPE Professional Development Day
New Brunswick, NJ