A sense of urgency......are you ready to meet the

Track & Trace deadline?

Laetus S-TTSSecure Track & Trace Solutions

Carlos Guidobono, Sindusfarma, Sao Paulo 2013.Area Sales Manager Laetus GmbH

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Secure Track & Trace SolutionsWhy does the WORLD need traceability?

To be compliant with international legislations and to be prepared for future requests

To fight against counterfeit products in the pharmaceutical supply chain

To ensure Patient Safety!

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Source:

Secure Track & Trace SolutionsWhich systems for traceability do we focus on?

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Emerging Pharmaceutical LegislationWe start seeing “the wall”

20xx 2010 2011 2012 2013 2014 2015 2016 2017

The traditional Quality & Security InspectionSpecific „island solutions“ with little interdependence or IT impact

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Pack security

Label inspection

Quality inspectionFill inspection

Code & Print verification

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ISA 95 StandardsWe better get used to these

T&T

Corporate IT

ERP / MES

DevicesMachines

Processes

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T&T software architectureModular, flexible, scalable and GAMP-compliant

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CLevel 1 – Cell configurations on demandEasily adapted to different packaging levels

SerializationCM&V

AggregationC

I-M&V

CIC-M&V

InspectionCI

CM&V

CI - M&V

CIC - M&V

CI - M&V

CI - M&V

Configuration example for serialization & multi-level aggregation (to comply with: Anvisa Brazil, California e-Pedigree)

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LLevel 2 – Line autonomyConfigure and manage each line to meet production needs

Level 3

Level 4

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• Production order data, billof material, shipping orderdata

• Serial codes forcode poolhandling • SAP AII, SAP OER, Werum Pas-X,

IBM, Rockwell, Oracle, Kezzler,customized (e.g. EPICS based)

• Code requests• List of used codes • Productionstatistics andcounters

• Aggregation list

Level 3 – Plant controlMaintain a single point of DB management P

P

ERP / MES

Level 3

Level 3

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• Download of data fromrunning or finishedproduction order

• De-Aggregation and Re-Aggregation

• Upload of newaggregation tree toLevel 3 (PlantManagement)

Level 3 – Warehouse managementThe starting point for a secure supply chain management W

W

P

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Overview Laetus S-TTS portfolioMV-50 and MV-70 systems for carton marking

MV-50, the most compact T&T cellOnly 0.5 m line space neededSimple and secure operationFront or backside printing

MV-70, the most versatile T&T cellAll kinds of printing technologies (TIJ, DOD, Laser)Labeling and/or Tamper-evident modulesAll side printing (back, front and top)

Stand alone or inline operationAutomated reject integrated

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Secure Track & Trace SolutionsLaetus turn-key solutions, OEM machines or retrofits

Flexibility to integrate S-TTS in any kind of packaging machines

Laetus MV-XX machinesNew machinesRetrofit of legacy machines

Multiple solutionsAt-Line (stand alone) In-Line (MV-XX module integration into line layout)On-Line (integration into packaging machines)

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Overview Laetus S-TTS portfolioIM-400 Hand Packing and Warehouse module

Movable all-in-one station for manual aggregation

Easy to use hand packing stationIn warehousesAt wholesalers

Multiple child codes reading via integrated camera system

Efficient operation due to dedicated HMI

• Pharma companies

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References of our Customer BaseLaetus is a trusted Partner worldwide

• OEM’s• Other industries

…and many others

T&T requires different project managementGet ready for some truly interdisciplinary project teams

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Get prepared to share the table with a group of external experts that help you planning, executing and maintaining these T&T solutions.

Interdisciplinary also externalOne single partner will no longer be sufficient

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Secure Track & Trace SolutionsA collection of useful Information

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Secure Track & Trace SolutionsThe S-E-C-U-R-E way with Laetus as your partner

Strong and experienced partner with proven T&T solutionEasy expandable and configurable solution portfolio

from SAP interface to barcode reader

Competent and global project management team

User friendly and easy operating concept

Reliable service support – locally, all around the world

Embedded in financially strong group

Thank you

Get started now……time is running out!

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Laetus: Your partner for T&T solutions