Serialization and Track Trace - Implementation Methodology

8/18/2019 Serialization and Track Trace - Implementation Methodology

http://slidepdf.com/reader/full/serialization-and-track-trace-implementation-methodology 1/19

Serialization and Track & Trace -Implementation and Lessons Learned in Pilot Project

David Treadaway, Clarkston Consulting

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Real Experience. Real Advantage.

[ Agenda

Project Overview & Objectives

Business Drivers for Project

Environment

Regulatory & Legislative Drivers

Project Approach Package Labeling

Project Methodology

Key Lessons & Takeaways

Planning Implementation

Legislation

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[ Presenters

David Treadaway – Senior Manager

Clarkston Consulting

Serialization and Track & Trace

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[ Project Overview & Objectives

Define total Serialization & Traceability Business Processes

Deploy Serialization and Traceability

(Proof of Concept, Engineering Trials, Production Go-Live)

Implement SAP Auto-identification Enterprise (AIE)

Leverage SAP standard interfaces SAP ERP(s)

Packaging line controller system & packaging line operations

Warehouse Operations

Validate entire system to meet GAMP v5 requirements. Productive Go-Live

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[ Business Drivers

Safe and Secure Supply Chain

Patient Safety: Eliminate counterfeit medication that hurts your

patients

Protect brand from counterfeiting, tampering, theft and diversion

Targeted recall management

Reimbursement / Fraud / Tax Compliance (Turkey, Brazil)

Compliance

USA: Provide ePedigree from point of manufacture

EFPIA and Worldwide Legislation for Serialization and Authentication

Business Efficiencies

Better destruction & returns management

Improve accuracy and minimize erroneous chargeback

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[ Client’s Environment

Serialization needed to provide solutions for:

In-house warehouse & 3PL distribution centers

Manufacturing facilities / packaging lines

Contract manufacturing/ contract packaging organization

Global corporate-wide participation

Serialization needed to provide world-wide regulatorysolutions

Turkey

France

Brazil

EFPIA

US: California

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http://slidepdf.com/reader/full/serialization-and-track-trace-implementation-methodology 7/19Real Experience. Real Advantage.

[ Regulatory Compliance

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*Based on HDMA

http://www.healthcaredistribution.org

No Legislation / Regulations/Rules

Pending Legislation / Regulations/Rules

Enacted Legislation/Regulations/Rules

Current Legislation / Regulation Status *



[ EFPIA & ROW Legislation

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[ Project Implementation Approach

ProjectStartup

Proof of

Concept(Serialization)

Engineering

Trials(Track

&Trace)

Validation

Go-Live

and RollOutStrategy

Initial Work Plan

Scope

Project Tools &

Standards

Install System

Risk Analysis

Project Teams

Critical Success

Factors &

Metrics

Project Charter

Requirements

Gathering

Workshops

FunctionalSpecification

SAP ECC, SAP

Aie, MES server,

Packaging Line,

Bar-coding

Scanning system

and ShippingStation

Test

serialization

processes

Proof of concept

sign-off

Configure track &

trace processes

Verify processes

through bar codescanning &

shipping station

Reporting

Unit & integration

tests

Test serialization

& traceability

processes through

trading partner

Validation master

plan

Engineering trials

Sign-Off

Finalize/ migrate

serialization

solution to quality

environment

Validation masterplan (Global AIE,

MES, packaging

line)

Update impacted

SOPs

Knowledge

transfer Develop cutover

plan

Migrate validated

solution to

Production

Provide go-live

support

Document

lessons learned Develop roll-out

strategy

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ProjectStartup

Proof ofConcept

(Serialization)

Engineering

Trials

(Track & Trace)

Validation Go-Live

Conduct Requirements Gathering Workshops

Functional Specification Development

Install/setup SAP ECC, SAP Aie, MES Server, Packaging Line

Test Serialization Processes

Proof of Concept Sign-Off




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Project Startup

Proof of

Concept

(Serialization)

Engineering

Trials(Track & Trace)

Validation Go-Live

Configure Track & Trace Business Processes

Warehouse Processes with Bar Code Scanning and Shipping Station

Perform Unit and Integration Tests

Test Serialization and Traceability Processes

Develop Validation Master Plan & Strategy

Engineering Trials Sign-Off




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Project Startup

Proof of

Concept

(Serialization)

Engineering

Trials

(Track & Trace)Validation Go-Live

Finalize & Migrate Serialization Solution to Quality Environment

Execute Validation Master Plan

Fully Test AIE System

Update impacted SOPs

Perform Knowledge Transfer to Site Staff

Develop Cutover Plan

Migrate Validated Solution to Production



[Serialization & Traceability

Tracking & Tracing throughout entire Supply ChainCapture each action that is performed against a productitems / ease / pallet

PRODUCTION WAREHOUSE RETAILER HOSPITALDISTRIBUTION CENTER CUSTOMS

Compliance

Brand Protection

Supply Chain Visibility

Product VerificationEnsure product genuineness (at point ofdispense or any other supply chain entity)

Serialization at Packaging lineCreate unique ‘license plate’for each saleable unit

Object

Event Repository

Communication w/ AuthoritiesSend registered products /

import notifications

GOODS ISSUES

PICKING

PACKING

SCANNER

• DATA CARRIER

• DATA CONTENT:

– Product Code

– Serial Number

– Lot Number

– Expiry-Date

Product RegistrationRegister product data inbackend data repository

Verification Request• Check for product registration• Return response to caller Traceability

to the patientin the hospital

Process Business Events• Build hierarchical relations• Link objects to delivery documents

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[Serialization & Traceability Logical System Landscape

Implemented

SAP Auto-ID (Aii)

SAP Object Event

Repository (OER)

SAP ProcessIntegration (PI)

L3: Line Controller

Manufacturing

Execution System

(MES)

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SAP OER (Global)

Auto-ID

Infrastructure(Global)

L3 System (Site Specific) Line Controller

L2 Systems (Site Specific)

SAPERP

SAP PI

(Global)BI

L1 Systems (Site Specific)



[ Serial Number Commissioning

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Aggregated

Flat



[ Package Labeling

Unit Carton: 2D Barcode

GTIN, SN, Expiry Date, Batch/Lot #

AI(01), (21), (17), (10)

Bundle: same as Unit Carton

Case: 2D & Linear Barcode GTIN, SN, Expiry Date, Batch/Lot #, Quantity

AI(01), (21), (17), (10), (30)

Pallet: Linear Barcode

SSCC-18 linear barcode GTIN - AI(02) & Quantity – AI(37)

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This is a facsimile only,NOT an actual carton.



[ Key Lessons

Start early – really early

Strong program management critical

Advanced planning – understand technical and human resource

requirements

Data & standards present harmonization challenges

Process standardization – cross-enterprise framework

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[ Key Takeaways

1. Technology matters.

2. Approach serialization a piece at a time.

3. Doing serialization right takes time, investment and hard

work.

4. Get ahead of the legislation – it’s worth it 5. Design/Allow for global variation in requirements

6. Master data harmonization – always bigger than anticipated

7. Everyone must understand the validation requirements

8. You can never have too much testing

9. Thorough cutover planning is critical

10. Don’t forget the real business imperative

behind this – patient safety.

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[

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[

] Thank you for participating.

SESSION CODE:

3106

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Serialization and Track Trace - Implementation Methodology