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 2014. Area Sales Manager Laetus GmbH
Secure Track & Trace Solutions Which systems for traceability do we focus on? Source: 2
Emerging Pharmaceutical Legislation We start seeing the wall 20xx 2010 2011 2012 2013 2014 2015 2016 2017 3
Pharma Track & Trace Understand the Magnitude & Complexity 4
Pharma Track & Trace The complexity of a Track & Trace architecture is based on three main issues. Serialisation Aggregation IT-Datamanagement OEE! 5
Magnitude & Complexity Get ready for some truly interdisciplinary project teams Corporate IT Production / OEE ERP / MES Support T&T Devices / Machines Project Engineer Documentation Validation Processes 6
Comprehensive T&T System Solutions Fully embedded, highly complex, customized with real-time IT needs 7
T&T software architecture Modular, flexible, scalable and GAMP-compliant 8
ISA 95 Standards The international nomenclature 9
3 Level Secure Track & Trace S-TTS 3 levels cover all ISA 95 needs Level 4 Interfaces Level 3 Plant & Warehousing Level 2 Line Management Level 1 Cell Management Level 0 Hardware Device Level 10
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 11
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 12
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 13
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 14
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) 15
Secure Track & Trace Solutions From easy to complex architecture Serialization at single packaging line: 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 16
Secure Track & Trace Solutions From easy to complex architecture Serialization & Aggregation at n packaging lines: 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. Aggr Aggr Aggr Aggr 1 2 3 n 17
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 18
Overview Laetus S-TTS portfolio CS-60 Manual Hand Packing module CS-60 COMMANDER Station Desktop label printer MMI Hand Help Scanner 19
Overview Laetus S-TTS portfolio IM-410 Semi-Automatic Aggregation module IM-410 Semi automatic aggregation for cases and bundles Large work area IHM Printer Hand Held Scanner 20
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 21
References of our Customer Base Laetus is a trusted Partner worldwide Pharma companies Other industries OEM s and many others 22
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 www.securetrackandtrace.com 23
Get started now time is running out! Thank you Laetus: Your partner for T&T solutions 24