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

Track & Trace deadline?

Laetus S-TTSSecure Track & Trace Solutions

Carlos Guidobono, Sindusfarma, Sao Paulo 2014.Area Sales Manager Laetus GmbH

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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

Pharma Track & TraceUnderstand the Magnitude & Complexity

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Pharma Track & Trace

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Serialisation Aggregation

IT-Datamanagement

The complexity of a Track & Trace architecture is based on three main issues.

OEE!

Magnitude & ComplexityGet ready for some truly interdisciplinary project teams

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T&T

Corporate IT

ERP / MES

Devices / Machines

Documentation

ProcessesValidation

Project Engineer

Support

Production / OEE

Comprehensive T&T System SolutionsFully embedded, highly complex, customized with real-time IT needs

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

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ISA 95 StandardsThe international nomenclature

Level 3Plant & Warehousing

Level 2Line Management

Level 1Cell Management

Level 0Hardware Device Level

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3 Level Secure Track & TraceS-TTS´ 3 levels cover all ISA 95 needs

Level 4Interfaces

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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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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)

• Serialization at single packaging line:

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Secure Track & Trace SolutionsFrom easy to complex architecture

• See Laetus machinery portfolio• S-TTS Express SW package installed on

one machine:• S-TTS Plant Express License and

USC Generator• S-TTS Line License• S-TTS Cell License (Serialisation)• Additional S-TTS Cell License Aggregation

• Serialization & Aggregation at “n” packaging lines:

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Secure Track & Trace SolutionsFrom easy to complex architecture

• Just add the Serialization and Aggregation cells to the existing architecture!

• Manage the level of aggregation via numbers of aggregation cells along the packaging line.

1 2 3 n

Aggr Aggr Aggr Aggr

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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

Overview Laetus S-TTS portfolioCS-60 Manual Hand Packing module

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CS-60• COMMANDER Station • Desktop label printer • MMI • Hand Help Scanner

Overview Laetus S-TTS portfolioIM-410 Semi-Automatic Aggregation module

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IM-410 •Semi automatic aggregation for cases and bundles •Large work area•IHM•Printer•Hand Held Scanner

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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

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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

www.securetrackandtrace.com

Thank you

Get started now……time is running out!

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Laetus: Your partner for T&T solutions