Laetus Track & Trace Solution

16/10/2017

16/10/2017

Marcia Erdelyi - ERTEC

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1. Introduction Laetus

2. Solution portfolio

3. Laetus Secure Track & Trace

4. Project management & service concept

5. Track & Trace Academy

Agenda

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Company overview

Facts & figures

founded in 1974

headquarters in Alsbach & Bensheim (Germany)

with branches in US, MX, BR, CN, IN, UK/IR,

IT, ES, PL and FR

> 250 employees and over 50 agents worldwide

~ 40Mi Euro annual turnover

18.000 systems sold and installed

(42.000 cameras/ sensors) worldwide

> More than 300 lines with T&T Solution worldwide,

Pharma & Non-Pharma Projects

more than 3.500 customers

-

Danaher at a Glance

Facts & figures

Global diversified science & technology

enterprise

$20 billion in sales, 70,000 employees

Growing at 15+% per year over last 10 years

More than 100 operating companies worldwide

Strong performance and cash flow

Sustainable business model – Danaher

Business System (DBS)

-

Laetus – Member of Danaher’s PID Platform

Dental Life Sciences

& Diagnostics Test &

Measurement

Product

Identification Environmental

Communications

Instruments

Water Quality

Gilbarco Veeder-

Root

Dental Diagnostics

Life Sciences

Product ID

-

Solution portfolio

Vision Inspection Track & Trace

-

Solution portfolio – changing business

2013

01. 02. 03. 04. 05. 06. 07. 08. 09. 10. 11. 12.

2014

01. 02. 03. 04. 05. 06. 07. 08. 09. 10. 11. 12.

2015

Line 1Line 3

Linie 11

Linie 12

Linie 13

Linie 14

Linie 15

Linie 16

Linie 18

Hillsboro

Linie 41

Linie 42Linie 43

Linie 44

Linie 45

Linie 52

Linie 60 P1 Linie 60 P2

Linie 62Linie 63

Linie 64 P1

Linie 93 P1

RCP 3

Aylward 1Aylward 2

C 901

Uhlmann IMA

SCC CoE Implementation Timelines 1/2

Kaise

raugst

Leganés

01. 02. 03. 04.

C 902

Linie 65

RCP 4

Linie 64 P2

In Planning New LinePlanned US CN KOReady for

Linie 93 P2

Products Projects Programs

Traditional Business S-TTS Business

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Solution portfolio

Different needs Different solutions

(different products) (different mark & verify devices)

-

INTEGRATION

Different devices

marking verify I/O

STAND ALONE SOLUTION

Producing of pre-printed labels

print verify eject

AUTOMATED FULL MACHINE

Different pack handling systems

marking verify eject

Solution portfolio – serialization

Different ways to implement serialization processes.

-

INTEGRATION

Different devices into existing machine

mark I/O

Solution portfolio – aggregation

Different ways to implement aggregation processes.

read inspect verify

MANUAL SOLUTION

Mobile station

aggregate scan label

SEMI-AUTOMATED SOLUTION

Mobile station

aggregate multi-scan label

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- Laetus T&T Users around the World:

- More than 300 validated lines with Laetus,

- T&T Solution worldwide

- Laetus pilot for ANVISA RDC’S 2017:

- Serialization with MV-50

- Manual or Semi automatic Aggregation with module CS- 115

- Full Automatic Aggregation, carton, case and pallet

- Levels 3, 4 and 5 interfaces.

1. P

2. T

T&T USERS - PILOT LINE

-

CI-M&V

X. Line

Server

S-TTS

1. Line

Server

S-TTS

Laetus

Cell

(Level 1)

Laetus Secure Track & Trace – architecture

Corporate

Enterprise

Level

(Level 4)

Laetus

Plant

(Level 3)

Laetus

Line

(Level 2)

S-TTS

Plant

Enterprise

Database

CM&V

Interface (EC)

…

…

Laetus S-TTS is based on ISA-95

standard. It is divided into:

L3: Plant server (for multi-line

management, installed on HW / VM*)

L2: Line server (cell management)

L1: Cells (device management)

Included functionalities:

Unique serial code generator

Serialization & aggregation

External code import with USB stick

Re-open-batch (re-work processes)

Additional options (see next slides):

Interface to Level 4 systems

Warehouse functionalities

ERP/ MES

* Notes: HW = Hardware or VM = Virtual Machine

-

CI-M&V

X. Line

Server

S-TTS

1. Line

Server

S-TTS

Laetus

Cell

(Level 1)

Laetus Secure Track & Trace – architecture

Corporate

Enterprise

Level

(Level 4)

Laetus

Plant

(Level 3)

Laetus

Line

(Level 2)

S-TTS

Plant

Enterprise

Database

S-TTS

Warehouse

function

CM&V

Interface (EC)

…

… WH

CS-60

Warehouse function:

Additional warehouse

module (software)

Covers commissioning

processes

Allows to manage

shipping orders

Re-aggregation of

products from different

batches into a new

container (case or

pallet)

Warehouse stations:

Different pack handling

systems for manual or

semi-automated

processes available

additional warehouse

functionalities

ERP/ MES

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CI-M&V

X. Line

Server

S-TTS

1. Line

Server

S-TTS

Laetus

Cell

(Level 1)

Laetus Secure Track & Trace – architecture

Corporate

Enterprise

Level

(Level 4)

Laetus

Plant

(Level 3)

Laetus

Line

(Level 2)

S-TTS

Plant

Enterprise

Database

CM&V

Interface (EC)

…

…

Laetus External Communicator (EC):

Provides standard channels for

exchanging master data, production

request and response data and serial

codes and their statuses

Transport formats (SOAP over

HTTP/S and XML file exchange)

Data formats (EPCIS, PML, IDOC

and XML)

Already realized with SAP ERP/ AII/

OER, TraceLink, Rockwell

Automation, Werum, Kezzler, etc.

Whole documentation provided in our

additional EC technical information

PDF document.

ERP/ MES

* Notes: SOAP = Simple Object Access Protocol (web service)

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Laetus Secure Track & Trace – architecture

Laetus S-TTS is a sustainable and flexible

solution. Depending on the existing line

hardware and space, different cell solutions

at level 1 are possible:

Full integration of S-TTS cells devices into existing machines

(retrofit)

Full automated machines for serialization and aggregation

Semi-automated and manual stations

Laetus

Cells

(Level 1) C

I-M&V

CM&V

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Laetus Secure Track & Trace – architecture

Market + Checkweigher (CW) Serialization only

2D Data Matrix

+ human readable

Text

+ Tamper Feature

Regulation

can be used

without Vignette

Labeler

can be used

mandatory

Examples

2D Data Matrix

+ human readable

Text

+ 5th line (NHRN)

Code 128C provid-

ed by China FDA

+ human readable

Text

2D Data Matrix

+ human readable

Text

2D Data Matrix

+ human readable

Text

2D Data Matrix

+ human readable

Text

Tamper

Verification

Feature NOT

included

Used for

manual or

automatic

labeling

Tamper

Verification

Feature NOT

included

additional

cascaded print

head needed for

NHRN printing

three layouts

available, (Chinese

characters mostly

pre-printed)

can be used

for secondary

packages of

bottles

With Vignette for BE,

IT, FR, Tamper

Verification Feature

NOT included

+ LASER/ TIJ/ DOD

+ Vignette (VL)

can be used

without Vignette

Labeler

can be used

without Vignette

Labeler

can be used

without Vignette

Labeler

can be used

without Vignette

Labeler

+ LASER/ TIJ/ DOD

+ Tamper Evident (TL)

+ Vignette (VL)

+ LASER/ TIJ/ DOD

+ Tamper Evident, w./o. Vignette

+ Checkweigher (CW)

MV-220 (Desktop Printer) MV-50-C (only TIJ) MV-60-C (only TIJ) MV-70-C (TIJ,DOD,Laser) MV-70-F 160 TL (TIJ,DOD,L.) MV-70-F 240 CW (Checkweigher)

NOT

mandatory

Different pack handling systems for serialization processes available:

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Laetus Secure Track & Trace – architecture

Different pack handling systems for aggregation processes available: Market

Semi-Manual Aggregation of

sales units into shipper case

Automatic Aggregation

of Bundles

Regulation

Examples

Semi-Manual Aggregation of

Cartons into shipper case

Semi-Manual Agg. of cartons

or Bundles into shipper case

(up to 3 Aggregation steps)

Manual Aggregation of

Shipper Cases or Pallets

IMV-370 (Print & Apply) CS-60 (Scanner, Printer)

IM-400 (single shot) IC-150 (multi shot)

single shot

manual

multi shot

(automatic)

...

manual

CS-115 (single shot)

2D Data Matrix

+ human readable

Text

+ Tamper Feature

2D Data Matrix

+ human readable

Text

+ 5th line (NHRN)

Code 128C provid-

ed by China FDA

+ human readable

Text

2D Data Matrix

+ human readable

Text

2D Data Matrix

+ human readable

Text

2D Data Matrix

+ human readable

Text

mandatory

NOT

mandatory

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Laetus Secure Track & Trace – full track & trace

The flexible cell structure allows to expand lines for future needs

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Project management competence

Project planning phase

• On-site survey

• General contractor

• Definition of communication

channels

• Consulting

• Feasibility study

• URS review and comment

Project design phase

• Creation of FS

• Preparation of IOQ

• Individual documentation

• Project controlling

Project developing phase

• GAMP 5 compliant development

• Integration of 3rd party equipment

• Functional application test

Project test phase

• Pre-FAT of 3rd party equipment

• Application testing

• Final FAT Project deploy phase

• Installation of equipment

• Assistance at SAT

• Performance of validation / IOQ

• User-group specific training

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Service competence

Training courses

• Training at several levels of operation

• Individual trainings

• Local flexibility

Technical services and support

• Remote access

• Hotline counseling

• Remote updates and maintenance

Supply of spare parts

• On site exchange

• Validation documentation

• Long spare part availability

Worldwide services

• Worldwide distribution and service center

• Increased response time

• Local trainings

Service Level Agreements

• Individual scope of services

• Secured guarantees and warranties

• Plant hires and machines by rent

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Laetus Track & Trace Academy – Training

Different class rooms &

courses:

• Training for different user

rolls customized to

individual requirements

• Direct training with life

connection to machines

Demo Line:

• Full Line with different

serialization and aggregation

solutions

• Full access to all machines

from all class rooms due

web technology (wt)

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Summary – core competences

Our proven solutions make us a true full solution provider

LAETUS

Control

LAETUS

Control

LAETUS

Support

INSPECT

Quality

Inspection

POLYPHEM

Fill Inspection

Track &

Trace Software

engineering

OEE

ARGUS

Code &

OCR/OCV

Service

Validation

Training

Consultancy

Laetus Track & Trace Solution

Thank you for you attention

Marcia Erdelyi - ERTEC