SEIDENADER MASCHINENBAU GMBH

Transcription

1 SEIDENADER MASCHINENBAU GMBH Track & Trace ILMAC Lunch & Learn Basel, September

2 Strong Brands Within a Strong Group 9/30/2013 Seidenader T&T Presentation sste 8

3 Company Profile Founded in employees worldwide Products Inspection machines for injectables and tablets Vision systems in pharma packaging lines Serialization solutions Operator interface and data management systems Headquarters Markt Schwaben / Germany Markets 95% pharmaceutical industry - worldwide 10

4 Areas of Competency Seidenader is organized in two business units: Inspection machines Track&Trace 11

5 Serialization and e-pedigree on pharmaceutical packaging lines 12

6 Serialisierung und E-Pedigree für pharmazeutische Verpackungslinien Weltweit initiieren Gesetzgeber Richtlinien, die helfen sollen, gefälschte Medikamente zu erkennen und deren Verbreitung zu verhindern. Arzneimittelfälschungen führen nicht nur zu erheblichen Verlusten für die Pharmaindustrie, sondern gefährden vor allem die Gesundheit der Patienten und deren Vertrauen in Medikamente. Um diesen neuen oder auch bestehenden Anforderungen gerecht zu werden, stehen Pharma Unternehmen der Herausforderung gegenüber, den bestehenden Verpackungsprozess mit einem entsprechenden Serialisierungskonzept zu versehen. 28

7 Corporate / IT Level Project Preparation Packaging Area Requirement Data Carrier Line 1 Line 2 Item Coding Item Serialization 1D Barcode 2D Matrix Code Human Readable Text Line 3 Line n Aggregation 29

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9 Key Facts about T&T Components of a T&T solution Analyzing the processes (POIs) Involved People Is your supplier asking the right questions? Product People Process 32

10 POI 3 Upstream connection Serialization POIs POI 1 Item Level POI 2 End-of-Line Aggregation 33

11 Is your supplier asking the right questions? Topics for discussion Identification / Verification within the packaging process Code clearly visible (layers, foil, ) Space for HW integration Support of machine manufacturer Exchange of data Exception handling / Re-work scenarios Trainings for operator, technician, People Product Process 34

12 Product T&T Software Hardware Service Documentation People Product Process 35

13 Product T&T Hardware Item Level 36

14 Seidenader as Solution Provider Product T&T Hardware End-of-Line End off line solutions based on Manual work stations Integrated solutions (automatic) Main Task: Clarification with 3rd party equipment 42

15 L3 MES ERP L4 MLS Post-Lot Operation Process Manager Rework / QA QA Sampling. De-aggregate. De-commissioning. Printing, etc. L2 L3 MLS Site-Level Gateway Process Manager Line Management Software S/N Number Management Material Master Data Label File Management Goods Movement Seidenader L1 machine vision, scanners, printers, label files Packaging Operations Production Orders Batch Start. L0 Seidenader SingleUnit Machine print & verify item-level serialization end-of-line equipment 9/30/

16 Customer solution Product T&T Software Configuration C1 C2 Cn Standard Modules 20% Custom 15% Configuation 5% Customization 80% Standard software Re-Usable standard modules Robust process automation platform M1 M2 M3 M4 M.. M.. M.. M.. M.. M.. M.. Mn ProcessManager Platform 44

17 The key is: modular but standardized... M8 ERP / MES / M2 Interface ERP / MES / M1 M2 Interface ERP / MES / M1 M3 Interface M1 C1 Seidenader M5 M1 M3 M1 M3 Seidenader Seidenader C2 M5 C3 Project A Project B Project C shorter projects higher stability lower investment cost 45

18 Product T&T Software 46

19 Product T&T Software 47

20 Product T&T Software 48

21 Project Sponsor Project Sponsor Project Organization Program Manager Program Manager Roll-out team n Roll-out team 1 Project Manager Core Team Project Manager Roll-out team n Roll-out team 1 Project Manager Core Team Project Manager Project Manager Validation Project Engineer Manager Validation Project Engineer Manager Validation Project Engineer System-/SW Manager Validation Engineers Engineer System-/SW Validation System System-/SW Engineers Engineer Technicians Validation Engineers Engineer System System Technicians Technicians Project Manager Validation Project Engineer Manager Validation Project Engineer Manager IT Representative Validation System-/SW Manager Engineers Validation Engineer System-/SW Validation System Business Engineers Engineer Technicians Test Representatives Engineer(s) System Subject Technicians Matter Experts 50

22 Project Organization Elements of Project Delivery Methodology Sales Project Initiation Specification and Design Implementation Integration on Site Support Processes and activities Documents Quality Gates Status Status Status Status Compliant with GAMP5 51

23 Project Organization Project start Understand Requirements Fit / Gap Analysis Minimize deviations All partners together! Proof of concept meeting Agreement on concept and its proof! All partners together! Implementation Stick to standards! Concentrate validation on deviations Lessons learned session Improvements for next projects! All partners together! 52

24 Project Delivery Philosophy Our focus is creating value for customers We work in a systematic and structured manner We reach out globally but provide local presence Our teams are flexible and respond quickly Customer satisfaction is key for us Our team talks your language 9/30/2013 Seidenader T&T Presentation sste 53

25 Thank you for your attention! 67