2015-2016 marketing plan - sharp · stable solutions that meet business and customer requirements...

Serializaton Overview Brand Protection Through

Serialization and Authentication

January, 2016

ABOUT US

© 2015 Systech International. Last updated August 2015 2

EXPERIENCE

30 YEARS EXPERIENCE

1ST GLOBAL SERIALIZATION DEPLOYMENT TRUSTED BY 19 OF TOP 20 PHARMACEUTICAL COMPANIES

OVER 1000 TOTAL CUSTOMERS

INNOVATION

ONLY PROVIDER OF 5-LEVEL STACK

PATENTED CONFIGURABLE SOFTWARE

PATENTED UNIQUE AUTHENTICATION IP

RECOGNIZED LEADER IN SOFTWARE DEVELOPMENT

RELIABLITY

1400+ ACTIVE LINES

RAPID AND CONSISTENT DEPLOYMENTS STANDARDIZED AND CONFIGURABLE

GLOBAL REACH

FULL GLOBAL COVERAGE

>50% OF BUSINESS OUTSIDE USA

ROBUST PARTNER NETWORK

SERIALIZATION TRACK & TRACE REQUIREMENTS


Argentina Unit Serialization Jan ’12 – 1st phase products

Jan ’13 – Additional products

Jul ‘13 – Additional products

Jan ‘14 – Additional products

Jul ‘14 – Additional products

ANMAT System with aggregation for

high-volume products

United States Manufacturers Jan ’15 – Lot-Level traceabilility and

verification of lot info

Nov ’17 – Unit Serialization - unit

and homogenous case

2023 – Track & Trace

European Union Unit Serialization Q1 ’19

Pharmacy Verification

Ukraine Unit Serialization Jul ’15 – Expecting 2-yr delay

Algeria Unit Serialization Jan ’14 – Expecting 2-3-yr delay

Brazil Track & Trace Traceability – buyer/seller

Dec ‘13 – Resolution No.

RDC-54

Dec ‘15 – 1st of 3 batches

due

Dec ’16 – All

products/batches due

SERIALIZATION TRACK & TRACE REQUIREMENTS


Turkey Track & Trace Jul ’10 – Serialized DataMatrix

Jan ‘12 – Traceability – MoH

system

Jordan Unit Serialization Jan ’17

Saudi Arabia Mar ’15 – Lot-level DataMatrix

Mar ‘17 – Serialized DataMatrix

TBD – Track & Trace pending

China Track & Trace (code 128c) ’11, ’12, & ’13 – In effect for EDL

’15 – In effect for all drugs

CFDA System

Mandatory unit/case aggregation

Veterinary Products (QR-

Code) ’15 – Vaccines

’16 – All veterinary Products

South Korea Jan ’13 – Lot-level DataMatrix

Jan ’15 – 30% Serialized

DataMatrix

Jan ’16 – All Products Serialized

DataMatrix and Track & Trace

Likely

India Unit- and case-level

serialization

Exports and

government sales ‘13-’15 – Systems pending

EU consensus serialization model

© Systech International | 2015

Pharmaceutical

Manufacturer and

Parallel Distributor Wholesaler Distributors Pharmacist Patient

Risk-based

verification

by Wholesale

distributors

National System 1 - n

Product

#

Batch

Expiry

S/N

European

Hub

Verification

upon

dispense to

Patient

Upload Data

TI/TS/TH Data Exchange Model

• 2015 TI/TH/TS – ASN856 following HDMA Guidelines • Paper or Electronic – Electronic Preferred

• FDA delayed enforcement for manufacturers, repackagers and wholesale distributors until May 1, 2015, and dispensers until November 1, 2015

• 2017 – Addition of serial numbers following GS1 standards, including EPCIS. Data Exchange transition from ASNs to EPCIS through 2022

• Electronic Required

Track & Trace captures data at

each step in the supply chain

across partner boundaries

Data captured and saved at each step

Manufacturer Packaging Wholesale distributors Dispenser


RDC-54 Track & Trace

I. Unique Identifier of

Medicine (IUM)

II. CNPJ (tax registration

number), business

name, address and

state of the companies

or establishments that

received the medicine

III.CNPJ, business name,

address and state of

transport companies

IV.Date and nature of the

movement of each of

the transactions in the

supply chain

V. Identifier code of

transport packaging CMO/CPO

AVISA

500 Manufactures - 7 Wholesalers - 51,000 Pharmacies

Manufacturer Wholesaler Pharmacist Dispenser

EPCIS

Product

Serialization

Database

EPCIS

Product

Serialization

Database


Classic Mindset

Produce a large number of identical units

With Serialization

Uniquely identify each unit

Associate items to their parents

SERIALIZED PRODUCT TRACKING

8 © 2015 Systech International. V1.2

SOLUTION

© 2015 Systech International. Last updated July 2015 9

Implement a serialization solution that:

Provides serial number range management

Serial number validation

Meets regulatory compliance

Can be upgraded and re-configured

Integrates with existing or new hardware

Deploys rapidly and scales with the business

Adapts to packaging and regulatory changes

Remotely supportable without having to wait

for an engineer to arrive

LEVEL 1 | DEVICE

LEVEL 2 | LINE

LEVEL 3 | SITE

LEVEL 4 | ENTERPRISE

LEVEL 0 | VERIFIED

LEVEL 5 | AUTHENTICATION

Serialization Architecture

Multi-Line Plant Operation

Standardization – modular implementation

Core Software Platform – base set of software/functions

used for serialization, independent of the packaging line.

Packaging Modules – reusable applications

Hardware selection

Core Software Platform

Guardian

Advisor

In-Lot Rework

Manual Palletizing

Post Lot Rework

Central Palletizing

Transfer Shipment

SAP Aii Interface

MES Interface

Level Packaging Integration Module

Item

PIM 110 – Carton Print & Verify

PIM 130 – Bottle Serialization on a Rotary Labeler

PIM 131 – Bottle Serialization on a Rotary Labeler with Top Code Association (Oriented)

PIM 132 – Bottle Serialization on a Rotary Labeler with Top Code Association within

Labeler (Oriented)

PIM 133 – Bottle Serialization on a Rotary Labeler with Top Code Association (Un-

oriented)

PIM 134 – Bottle Serialization on a Rotary Labeler with Bottom Code Association

(Oriented)

PIM 135 – Bottle Serialization on a Rotary Labeler with Bottom Code Association within

Labeler (Oriented)

PIM 136 – Bottle Serialization on a Rotary Labeler with Bottom Code Association (Un-

oriented)

PIM 140 – Bottle Serialization on an In-Line Labeler

PIM 141 – Bottle Serialization on an In-Line Labeler with Top Code Association (Oriented)

PIM 142 – Bottle Serialization on an In-Line Labeler with Top Code Association (Un-

oriented)

PIM 143 – Bottle Serialization on an In-Line Labeler with Bottom Code Association

(Oriented)

PIM 144 – Bottle Serialization on an In-Line Labeler with Bottom Code Association (Un-

oriented)

SOLUTION SUMMARY

PACKAGING INTEGRATION MODULE 110

CARTON PRINT & VERIFY

Advantages of approach

Stable solutions that meet business and customer requirements through the use of standards library

Enforce consistency across global deployments through the creation of methodologies and processes

Enable speedy and more efficient deployments through the use of document templates and pre-built configurations

Support rapid global scalability by providing Direct (Systech) and Indirect (Partners) a structured, defined approach to deployments

Maintain customer satisfaction post-implementation by providing quality manuals/documentation

POST-LOT CAPABILITIES

13 © 2015 Systech International. Last updated July 2015

TRULY SCALABLE – ADD AS YOU GO…

FLEXIBLE Singular, All Encompassing Foundation – add processes, steps, reconfigurations and

more..

Adaptable - Avoid costly reconfigurations

Palletizing – Automated / Manual & Centralized

Lot & Batch – Suspend & Resume

Reworks (Sandbox)

ONLY ONE with streamlined, centralized

operations within the same system

STORAGE, WAREHOUSING & REWORKS


SINGULAR INTEGRATION – REDUCED DATA ENTRY

Easy integration

WMS, SAP, JD Edwards, QAD

Test integrations in a Sandbox environment

Stand alone operation

Doesn’t require any other software

Build as you go – Deploy today and add more for tomorrow…

Storage, rework, batch records and shipping preparation

Systech is the ONLY ONE to provide a single

point of integration without a 3rd party vendor

QA RELEASE AND SHIPMENT


DATA INTEGRITY – VALIDATION - PREPARATION

ENABLES - Final Line/Site Operation

Shipping prep, QA testing, Release, Shipment

Track-and-Trace ready

Seamless upgrade to UniTrace

Integrates with 3rd party Level 4

PROVEN, SCALEABLE, RELIABLE Platform

Infinite # Lines

Infinite # sites

Supports all number formats

Regional and Global options

ONLY ONE delivering a complete serialization

solution stack with Track-and-Trace

Aggregation

Pallet

Case

Bundle

Unit

© 2015 Systech International. V1.2

VALUE OF AGGREGATION

In logistics (e.g. FedEx, UPS), can you imagine scanning every single bottle/carton

at every stage of the supply chain?

The only logical option is scanning only the cases or pallets.

If only the larger packages were serialized, there would be no tracking of the actual

unit of sale.

Without an association of units to parents, we do not have full Track and Trace with

information about where the units are at every stage of the supply chain.

17

Packaging Packaging WH Distributor Wholesaler Dispensation


SOLVE CHALLENGES

Serialization Data exchange Serial number generation & management Third parties & Multiple suppliers EPCIS repository

Track & Trace Validate source content at production Visibility and reporting of supply chain

movement Exception handling support


Manufacturing / Packaging Distributor Wholesaler Pharmacy

WHERE DO WE START?

When planning for a new deployment, several high level questions need to be

asked beyond the mechanical operation of the packaging equipment and what

levels require serialization

Which products?

Which markets? Which Regulations?

Which Production Lines?

How long will the line(s) be down?

How much will it cost? What resources are required?

How is the serialization data going to reach the supply chain?


Know the regulations that pertain to each market. Different markets pose different

requirements.

Some markets require serialization of all pharmaceuticals.

Some markets’ serialization requirements only cover particular classifications of

products (e.g., prescription medication).

Some markets require 2D Data Matrix codes with specific information encoded in

them in addition to specific human-readable data.

Some markets require inclusion of a National Reimbursement Number or application

of labels for similar purposes.

Some markets have specific inspection requirements, not just printing and

serialization, that may only apply to some products.

WHICH MARKETS?


The same product may exist in different forms based on the market and its

marking and/or serialization requirements. These variations should all be

considered different presentations of the same product.

MARKETS: PRODUCTS

21

Data Matrix

2 dimensional

Small footprint

Image reader decoded

Widely adopted by pharma

Code 128 Barcode

1 dimensional

Larger footprint

Widely supported in supply

chains by laser scanners

Required in China

QR Code

2 dimensional

Smaller footprint

Image reader decoded

China and baby

formula


PUTTING TOGETHER THE FULL SET OF REQUIREMENTS

The basic requirements must include:

Volume and speed of production

A detailed as-is process

A detailed to-be process

“Must-have” functions

Integration requirements to packaging line (communication, signaling, controller

programming, reject handling, additional hardware including Serialization hardware)

Exception handling

Security access

22

REQUIREMENTS: DATA MANAGEMENT IN THE SUPPLY CHAIN

23

Serialization at the packaging stage is only the beginning, put together the

requirements needed for managing the data beyond the packaging line

Volume of data based on production

Communication with distributors and logistics operations

Data visibility and monitoring

Managing Rework

Security of the data


DEPLOYMENT MANAGEMENT: DATA COLLECTION

Proper deployment requires solid information:

Think of a serialization deployment as an ERP/MES installation; it will affect several

departments (e.g., QA, Production, Warehousing, IT).

The configuration depends on the information provided (i.e., Garbage In Garbage

Out).

The amount of data needed is huge and may involve research and communication

with multiple sources.

Project delays can occur if Product and Market information need to be redefined in

the field.

Getting the correct data in the later stages of the project multiplies the effort and the

time lost.


FINAL WORD

Take an active role in the

implementation of the systems and

make the effort to be involved. There

will be changes, and the best way to

manage them is to be as informed as

possible to maximize the value of your

investment.

Communicate, Communicate,

Communicate!


ONLY ONE TO DELIVER


SERIALIZATION, TRACK & TRACK, AUTHENTICATION & ENGAGMENT

GLOBAL AND REGIONAL SOLUTIONS FOR ALL KNOWN REGULATIONS

PROACTIVE UPDATES TO SUPPORT REGULATION AMENDMENTS

ADAPTABLE AND RECONFIGURABLE FOR CHANGING BUSINESS NEEDS

GLOBAL DELIVERY TEAMS AND CERTIFIED PARTNERS WITH PROVEN EXPERIENCE

POST IMPLEMENTATION SUPPORT AND TRAINING 24x7x365

PROVEN INNOVATOR WITH PATENTED TECHNOLOGIES

2015-2016 marketing plan - sharp · stable solutions that meet business and customer requirements...

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