Real life expertise from Arvato Systems + Systec & Services

Transcription

1 ARVATO SYSTEMS Real life expertise from Arvato Systems + Systec & Services Dr. Martin Printz, Project Manager, Systec & Services Oliver Meihorst, Senior Key Account Manager, Arvato Systems Abcoude (NL), June 22, 2017 Abcoude, 22 June 2017

2 Agenda / Topics Expectations and Reality Build up your serialization system Know-How from serialization projects Make it FIT Processes Organization Technology Interfacing Partners

3 From Online Coding to Serialization Match Expectation and Reality for a Successful Transformation Within the Evaluation Progress URS: what steps must be done to find the right solution that fits our requirements? Know-How: do we have all the knowledge about serialization? IT-Landscape: what kind of system scenario would be the best for my environment? Pricing: is there a price model that fits our budget? Working together Within the Implementation URS: start Fit-Gap Analysis and discuss in detail specific requirements Know-How: use knowlegde from implemented projects IT- Landscape: define the interfaces for interacting systems and involve IT teams from start Pricing: implement the software in time, budget and scope

4 Build up your system in a flexible way Your system solution - What you can get - Software- Licenses Level 3 Software Level 4 Software Moduls for Aggregation, ERP- Integration, etc. What kind of solution you prefer? SW- Maintenance Hotline Release-Upgrades Hotfixes On-Premise Installation installed by your IT using own network use solution over web-browser release upgrades done by your IT Hosting Gateway Support S/N-Interactions with MAH/CMO S/N-Interactions with NVS/EU-Hub Level 1/2/3-Support 7x24 approach Private/Public Cloud Server, Operatingsystem, Databases, System-Maintenance Backup-Management Hosted by Arvato (Private Cloud) installed at Arvato Data Center using both networks use solution over web-browser release upgrades decided by you Hosted by Arvato (Hybrid Cloud) installed at Arvato Data Center using both networks use solution over web-browser release upgrades decided by Arvato

5 and a flexible pricing model What kind of pricing models we provide? A) You want to buy the licenses, install it on your site and pay for the Gateway only on demand one-time charge: SW-licenses monthly charge: SW-maintenance Gateway usage on demand charge: NVS/Bus. Partn. usage S/N transactions Gateway C) You want to buy the licenses and pay a fixed calculated monthly base for Gateway (limited rate or flat rate) one-time charge: SW-licenses monthly charge incl.: SW-maintenance Gateway usage NVS/Bus. Partn. usage S/N transactions Gateway B) You want to buy the licenses, but install it at Arvato and pay for the Gateway only on demand one-time charge: SW-licenses Hosting setup monthly charge: SW-maintenance Gateway usage Hosting usage on demand charge: NVS/Bus. Partn. usage S/N transactions Gateway D) You want to rent the licenses and want a completely full-service package (flatrate) monthly charge incl.: SW-usage Gateway usage NVS/Bus. Partn. usage S/N transactions Gateway only one time S/N-charging in whole lifecycle!

6 Example Schedule Project duration 6 month once ordered Duration [months] Task INTRODUCE SERIALIZATION MANAGEMENT Create URS Decide for supplier Place order Configure & Implement system Connect partner CMO 1 CMO 2 CMO 3 Logistic Connect to NVS EU-Hub Germany Additional Hardware (PCs, Scanner) SOP, Training GO-LIVE X

7 Typical situation these days Small / Mid size pharma companies Some serialization knowledge None to some line equipment is in place (up to line management) None to some manual serialization data exchange 0 to 20 Business partners (MAHs, CMOs, Logistics) Serialization at shop floor is Engineering know how Serialization data handling is something else and in between

8 Serialization layers within the ISA 95 model Serialization Management Decrease of Knowledge Line Management

9 Level Overview L1 - Devices Printing, vision inspection, rejection, handling material L2 - Packaging LM maps with L1 to manage HW and Data. Supports devixce integration with site systems L4 - Enterprise Management of all serialization and regulatory data and business processes, verification of accompaniying data of each SN L3 Site-level SW allocates SN to lines, verification of integrity of information submittes to Enterprise system, changes of aggregation hierarchy, processing of shippment L5 - Network Management of all serialization and regulatory data with partners, NVS, authorities

10 Serialization Landscape NVS Your Bus. Partners (CMO/MAH/3PL) Level 5 Communication GATEWAY EU, CN, USA, S. Korea ( S/N exchange for each Rx-batch/prod. order XY Pharma Company HQ Netherlands Level 4 ERP- Syste ERP- System Serialnumber Management Spain France Italy Level 3 Site Manager Site Manager Site Manager Site Manager Level 1 & 2 Line 1 Line n Line 1 Line n Line 1 Line n Line 1 Line n 22/06/17 10

11 A Real Life Example I Pharma company: ~200 products - 50 % to be serialized 2000 batches /year - 50 % to be serialized MAH for 30 % of portfolio CMOs 4 MAHs (as customers) 3 Logistic Partners 2

12 A Real Life Example II Manual approach Effort per batch: 0,5 days Effort 500 days/year Costs: ,- /year Parameter 1000 batches/year Cost of 600 / day System based Effort per batch: 1 hour Effort < 4,5 days/year Costs: 2.700,- /year Growth in demand for Serial Numbers in future? Organization and generation of Serial Numbers

13 Make it FIT Processes Technology Organization

14 Make it FIT - Processes Processes = main point to consider as technology is available Impact to various existing processes : purchase, planning, data management, product release, shipping, IT&data security, Introduces additional (nontechnical) stakeholders If you talk serialization management you should talk processes

15 Process Example IN-HOUSE PRODUCTION Serialized, no Aggregation National System Receipt, Check, Respond CSDB Core CSDB Gateway Create order and generate S/N (Planning) Assign order to packaging line and approve (Supervisor Production) Send order and S/N to line Auftragsrückmeldung mit S/N von LM verarbeiten Review order Change status of S/N (Supervisor Production) Report data incl. S/N to NVS Report order to NVS (Planning or QP) Release order in CSDB (Production approval) Line with Serialization- Equipment Create order Complete order and start production (Production) Produce order and finalize it (Production) Further Systems Red Box = Automated Process Order approval QP-release of order and batch

16 Make it FIT - Organization New combination of technical system with business behaviour Involvement of various departments e.g Purchasing, Planning, Production, Packaging, IT, QA/Release, Logistics Ownership of responsibility and data is spread Nobody is waiting for this extra work Coordination with partners (MAHs, CMOs) also on a technical/it level

17 Make it FIT - Technology Approach: Bottom-Up Decide on your technical landscape keep it simple Decide on your level 1 and 2 approach single source vs. multiple vendors Standardize as much as possible suppliers are busy these days Yield and Shield your data you connect local systems to the outside world

18 Options for Technical Coverage Keep it simple and avoid interfaces Gateway (Level 5) Repository (Level 4) Serialization Management System Serialization Management System Serialization Management System Site (Level 3) 1 System 1 System Line (Level 1 & 2) 1 or N Vendors Vendor 1 Vendor 2

19 Execute to fit DO s and DONT s Understand the dependencies and processes Know restrictricting timelines and deadlines Know your requirements (obvious and hidden) Consider a phased approach Fix the landscape while keeping systems open/flexible Know the availability of project team (internal & external) Internal Depart ments, budgets, External National + business partners Phase 1 prove by pilot Phase 2 roll out and finalize

20 Interfacing partners YOUR CMO IS IN A TYPICAL SITUATION means, CMO deals with: Regulations Availability of Engineering Availability of Know-How Several MAHs with different requirements Define your business rules and share them in advance with your business partner!

21 Why is Arvato the right fit for YOU? Your Perspective to 2019! Level 3-5 Integration: Completely integrated solution within your processes/workflows Flexible & dynamic solution: You define how to work with the solution Top 1 in Europa: Arvato is market leader in Europe for serialization systems (> 60% of EU-countries) Serialization experts in Europe: big partner network (i.e. OCS, Systec & Services, ERP suppliers) Arvato solution for all your Business Partner: connect your CMO/MAH/3PL to the Gateway Use local representatives: Know How from Germany but local representatives in NL, BE Project Lifecycle: appr % face-to-face meetings necessary, than per remote Data Center Expertises: Arvato is one of the leading data provider in Germany and NL Transparent Costs: flexible pricing models results in best fit for the customers business case

22 Thank you for your attention! Contact: First name Last name Arvato Systems IT.arvato.com

23 Your Contact Details Arvato Systems Oliver Meihorst Senior Account Manager Pharma Fuggerstraße Bielefeld Germany Phone: Mobile: IT.arvato.com Systec & Services Dr. Martin Printz Project Manager CSDB Emmy-Noether-Str Karlsruhe Germany Phone: Mobile: systec-services.com