Laetus S-TTS Secure Track & Trace Solutions Carlos Guidobono, Sindusfarma, Sao Paulo Area Sales Manager Laetus GmbH

Transcription

1 A sense of urgency......are you ready to meet the Track & Trace deadline? Laetus S-TTS Secure Track & Trace Solutions Carlos Guidobono, Sindusfarma, Sao Paulo Area Sales Manager Laetus GmbH

2 Secure Track & Trace Solutions Why 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! 2

3 Secure Track & Trace Solutions Which systems for traceability do we focus on? Source: 3

4 Emerging Pharmaceutical Legislation We start seeing the wall 20xx

5 The traditional Quality & Security Inspection Specific island solutions with little interdependence or IT impact Fill inspection Quality inspection Pack security Code & Print verification Label inspection 5

6 ISA 95 Standards We better get used to these Corporate IT Processes T&T ERP / MES Machines Devices 6

7 T&T software architecture Modular, flexible, scalable and GAMP-compliant 7

8 Level 1 Cell configurations on demand Easily adapted to different packaging levels C C Inspection I C M&V Serialization C I-M&V C IC-M&V Aggregation 8

9 Level 2 Line autonomy L Configure and manage each line to meet production needs Configuration example for serialization & multi-level aggregation (to comply with: Anvisa Brazil, California e-pedigree) C M&V C I - M&V C IC - M&V C I - M&V C I - M&V 9

10 Level 3 Plant control Maintain a single point of DB management P Production order data, bill of material, shipping order data Serial codes for code pool handling ERP / MES Level 4 SAP AII, SAP OER, Werum Pas-X, IBM, Rockwell, Oracle, Kezzler, customized (e.g. EPICS based) Code requests List of used codes Production statistics and counters Aggregation list Level 3 P 10

11 Level 3 Warehouse management The starting point for a secure supply chain management W Download of data from running or finished production order P Level 3 Upload of new aggregation tree to Level 3 (Plant Management) De-Aggregation and Re-Aggregation Level W 3 11

12 Overview Laetus S-TTS portfolio MV-50 and MV-70 systems for carton marking MV-50, the most compact T&T cell Only 0.5 m line space needed Simple and secure operation Front or backside printing MV-70, the most versatile T&T cell All kinds of printing technologies (TIJ, DOD, Laser) Labeling and/or Tamper-evident modules All side printing (back, front and top) Stand alone or inline operation Automated reject integrated 12

13 Secure Track & Trace Solutions Laetus turn-key solutions, OEM machines or retrofits Flexibility to integrate S-TTS in any kind of packaging machines Laetus MV-XX machines New machines Retrofit of legacy machines Multiple solutions At-Line (stand alone) In-Line (MV-XX module integration into line layout) On-Line (integration into packaging machines) 13

14 Overview Laetus S-TTS portfolio IM-400 Hand Packing and Warehouse module Movable all-in-one station for manual aggregation Easy to use hand packing station In warehouses At wholesalers Multiple child codes reading via integrated camera system Efficient operation due to dedicated HMI 14

15 References of our Customer Base Laetus is a trusted Partner worldwide Pharma companies Other industries OEM s and many others 15

16 T&T requires different project management Get ready for some truly interdisciplinary project teams 16

17 Interdisciplinary also external One single partner will no longer be sufficient Get prepared to share the table with a group of external experts that help you planning, executing and maintaining these T&T solutions. 17

18 Secure Track & Trace Solutions A collection of useful Information 18

19 Secure Track & Trace Solutions The S-E-C-U-R-E way with Laetus as your partner Strong and experienced partner with proven T&T solution Easy 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 19

20 Get started now time is running out! Thank you Laetus: Your partner for T&T solutions 20