Laetus Track & Trace Solution

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1 Laetus Track & Trace Solution 16/10/2017 Marcia Erdelyi ERTEC 16/10/2017

2 Agenda 1. Introduction Laetus 2. Solution portfolio 3. Laetus Secure Track & Trace 4. Project management & service concept 5. Track & Trace Academy

3 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 systems sold and installed ( cameras/ sensors) worldwide > More than 300 lines with T&T Solution worldwide, Pharma & NonPharma Projects more than customers

4 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)

5 Laetus Member of Danaher s PID Platform Environmental Test & Measurement Dental Life Sciences & Diagnostics Product Identification Water Quality Communications Dental Diagnostics Product ID Gilbarco Veeder Root Instruments Life Sciences

6 Solution portfolio Vision Inspection Track & Trace

7 Kaiseraugst Solution portfolio changing business Products Projects Programs SCC CoE Implementation Timelines 1/2 Hillsboro Line 1 Planned In Planning New Line Ready for US CN KO Line 3 Leganés Linie 41 Linie 12 Linie 93 P1 Linie 93 P2 Linie 60 P1 Linie 60 P2 Linie 65 Linie 18 Linie 15 RCP 3 RCP 4 Linie 11 Linie 64 P1 Linie 64 P2 Linie 63 Linie 62 Linie 42 Linie 43 Linie 13 Linie 45 Linie 14 Linie 52 Linie 16 Linie 44 Aylward 1 Aylward 2 C 901 C 902 Uhlmann IMA Traditional Business STTS Business

8 Solution portfolio Different needs (different products) Different solutions (different mark & verify devices)

9 Solution portfolio serialization Different ways to implement serialization processes. INTEGRATION Different devices marking verify I/O AUTOMATED FULL MACHINE Different pack handling systems marking verify eject STAND ALONE SOLUTION Producing of preprinted labels print verify eject

10 Solution portfolio aggregation Different ways to implement aggregation processes. INTEGRATION Different devices into existing machine SEMIAUTOMATED SOLUTION Mobile station MANUAL SOLUTION Mobile station read inspect mark verify I/O multiscan aggregate label scan aggregate label

11 T&T USERS PILOT LINE 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 MV50 Manual or Semi automatic Aggregation with module CS 115 Full Automatic Aggregation, carton, case and pallet Levels 3, 4 and 5 interfaces.

12 Laetus Secure Track & Trace architecture Corporate Enterprise Level (Level 4) ERP/ MES Interface (EC) Laetus STTS is based on ISA95 standard. It is divided into: L3: Plant server (for multiline management, installed on HW / VM*) L2: Line server (cell management) Laetus Plant (Level 3) STTS Plant Enterprise Database L1: Cells (device management) Included functionalities: Unique serial code generator Laetus Line (Level 2) STTS 1. Line Server STTS X. Line Server Serialization & aggregation External code import with USB stick Reopenbatch (rework processes) Laetus Cell (Level 1) C M&V C IM&V Additional options (see next slides): Interface to Level 4 systems Warehouse functionalities * Notes: HW = Hardware or VM = Virtual Machine

13 Laetus Secure Track & Trace architecture Corporate Enterprise Level (Level 4) ERP/ MES Interface (EC) Warehouse function: Additional warehouse module (software) Covers commissioning processes Laetus Plant (Level 3) Laetus Line (Level 2) STTS 1. Line Server STTS Plant Enterprise Database STTS X. Line Server STTS Warehouse function Allows to manage shipping orders Reaggregation of products from different batches into a new container (case or pallet) Warehouse stations: Laetus Cell (Level 1) C M&V C IM&V WH CS60 Different pack handling systems for manual or semiautomated processes available additional warehouse functionalities

14 Laetus Secure Track & Trace architecture Corporate Enterprise Level (Level 4) Laetus Plant (Level 3) Laetus Line (Level 2) Laetus Cell (Level 1) C M&V STTS 1. Line Server C IM&V STTS Plant Enterprise Database ERP/ MES Interface (EC) STTS X. Line Server 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. * Notes: SOAP = Simple Object Access Protocol (web service)

15 Laetus Secure Track & Trace architecture Laetus Cells (Level 1) C M&V C IM&V Laetus STTS 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 STTS cells devices into existing machines (retrofit) Full automated machines for serialization and aggregation Semiautomated and manual stations

16 Laetus Secure Track & Trace architecture Different pack handling systems for serialization processes available: Market Regulation 2D Data Matrix + Tamper Feature 2D Data Matrix + 5th line (NHRN) Code 128C provided by China FDA 2D Data Matrix 2D Data Matrix 2D Data Matrix Serialization only Tamper Verification Feature NOT included Tamper Verification Feature NOT included additional cascaded print head needed for NHRN printing three layouts available, (Chinese characters mostly preprinted) can be used for secondary packages of bottles can be used + Checkweigher (CW) + LASER/ TIJ/ DOD + Vignette (VL) With Vignette for BE, IT, FR, Tamper Verification Feature NOT included can be used without Vignette Labeler 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) Examples Used for manual or automatic labeling MV220 (Desktop Printer) MV50C (only TIJ) MV60C (only TIJ) MV70C (TIJ,DOD,Laser) MV70F 160 TL (TIJ,DOD,L.) MV70F 240 CW (Checkweigher) mandatory NOT mandatory

17 Laetus Secure Track & Trace architecture Different pack handling systems for aggregation processes available: Market Regulation Automatic Aggregation of Bundles Manual Aggregation of Shipper Cases or Pallets SemiManual Aggregation of sales units into shipper case SemiManual Aggregation of Cartons into shipper case SemiManual Agg. of cartons or Bundles into shipper case (up to 3 Aggregation steps) 2D Data Matrix + Tamper Feature 2D Data Matrix + 5th line (NHRN) Code 128C provided by China FDA 2D Data Matrix 2D Data Matrix 2D Data Matrix Examples single shot manual multi shot (automatic) manual... IMV370 (Print & Apply) CS60 (Scanner, Printer) IM400 (single shot) IC150 (multi shot) CS115 (single shot) mandatory NOT mandatory

18 Laetus Secure Track & Trace full track & trace The flexible cell structure allows to expand lines for future needs

19 Project management competence Project planning phase Onsite 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 3 rd party equipment Functional application test Project deploy phase Installation of equipment Assistance at SAT Performance of validation / IOQ Usergroup specific training Project test phase PreFAT of 3 rd party equipment Application testing Final FAT

20 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 Service Level Agreements Individual scope of services Secured guarantees and warranties Plant hires and machines by rent Worldwide services Worldwide distribution and service center Increased response time Local trainings

21 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)

22 Summary core competences Our proven solutions make us a true full solution provider LAETUS Control Track & Trace OEE Software engineering LAETUS Control ARGUS Code & OCR/OCV INSPECT Quality Inspection POLYPHEM Fill Inspection LAETUS Support Consultancy Training Validation Service

23 Laetus Track & Trace Solution Marcia Erdelyi ERTEC Thank you for you attention

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