laetus track & trace solution - sindusfarmalaetus secure track & trace – architecture...
TRANSCRIPT
Laetus Track & Trace Solution
16/10/2017
16/10/2017
Marcia Erdelyi - ERTEC
-
1. Introduction Laetus
2. Solution portfolio
3. Laetus Secure Track & Trace
4. Project management & service concept
5. Track & Trace Academy
Agenda
-
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
-
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
-
- 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
-
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)
-
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
-
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:
-
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
-
Laetus Secure Track & Trace – full track & trace
The flexible cell structure allows to expand lines for future needs
-
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
-
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
-
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)
-
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