The fast track to sap s:4 hana
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The document outlines Fujifilm Diosynth Biotechnologies' initiatives, focusing on their implementation of the SAP S/4HANA platform at the Hillerød manufacturing site, aimed at enhancing their contract development and manufacturing operations. It discusses the strategic necessity for transitioning from the Biogen Oracle platform, highlights key project management strategies, and emphasizes the importance of a structured and agile approach to ensure success amidst disruptions such as the COVID-19 pandemic. Additionally, it details the planned capacity expansion and ongoing projects, including partnerships to produce medicines for COVID-19.
The fast track to sap s:4 hana
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- 2. 4 Welcome and brief introduction The FUJIFILM Diosynth case S/4 approach and methodology Wrap-up and questions AGENDA
- 4. FUJIFILM Corporate Overview Established Chairman & CEO Shigetaka Komori # of Employees # of Subsidiaries Revenue Operating Income 279 as of March 2019 72,332 President & COO Kenji Sukeno as of March 2019 Jan 20, 1934 ￥２,480 billion ($23b approx.) ￥240 billion (approx. $2.3b) FY2019 (Estimation) FY2019 (Estimation)
- 5. FUJIFILM Diosynth Biotechnologies - World Leading CDMO +325 Projects In process development and/ or manufacturing 3 Technologies Microbial Mammalian Viral / gene therapy 4 Locations 14 Licenses For commercial manufacturing
- 6. Introduction to FUJIFILM Diosynth Biotechnologies (FDB) is a leading contract development and manufacturing organisation (CDMO) providing process development and manufacturing of biologics. At the Hillerød factory, there are currently 800 FTEs and plans to expand the capacity with investments of USD 928 million, which will increase the number of FTEs by 400. During the coronavirus crisis, the Bill & Melinda Gates Foundation has booked capacity at FDB in Hillerød to help with production of medicine to fight COVID-19. In April 2020, the factory in Hillerød went live with a Greenfield SAP S/4 Hana implementation. FUJIFILM DIOSYNTH BIOTECHNOLOGIES
- 7. Manufacturing Site Hillerød -70⁰ Celsius Warehouse 800 m2 Assembly, Label and Pack Facility 4500 m2 Large Scale Biologics Manufacturing Facility 21,000 m2 Utilities & Link 2,500 m2 Quality Laboratories 4,600 m2 Administration 4,200 m2 Canteen & Auditorium 1,500 m2 Warehouse 4,700 m2
- 8. Project background 12 WHY THE SITE IS IMPLEMENTING SAP • The Hillerød site is the first of the four sites to implement SAP S/4HANA – the other sites run SAP ECC. • With SAP S/4HANA, the site implements a long-term improved platform (the foundation bricks), supporting the future CDMO business model. Building the foundation bricks for the future • As part of the transition to FDB, the site in Hillerød needs to exit the Biogen Oracle platform and transition to the SAP platform. • In April 2020, the plug to Oracle was pulled. SAP S/4HANA needed to go live prior to this date to avoid penalty clauses. • Business operations need to continue As-Is. Launching SAP to replace Oracle • The Hillerød site is now the fourth biopharmaceutical manufacturing site of FDB. • SAP is the ERP platform used across all FDB sites. Merging into the FDB family
- 9. 13 Sub- projects Plan Source Make (DS+FG) Sell/deliver Core process Jaggaer Batch No. SyncadeAnalytics Warehouse QA/QC Finance Master data Reporting Indirect procurement Supporting processes Project scope SAP S/4HANA COVERS THE END-TO-END PROCESS
- 10. 14 SAP ECC SAP S/4 HANA Apr May Jun Jul Aug Sep Oct Nov Dec Jan Feb Mar Apr Scoping process and gap identification Project mobilisation New S/4HANA direction set Fit/gap and URS workshops Project kickoff ECC blueprint presentation Project restart S/4HANA Agile prototyping and design URS approval Dry-run test IQ test Go-live End-user training OQ test PQ (UAT) test Key design decisions Project timeline THE JOURNEY OF THE SAP PROJECT
- 11. 15 TIME SCHEDULE – VISUAL PLANNING
- 12. Examples of the project room Footer 16
- 13. 17 HOW TO COPE WITH DISRUPTION AND KEEPING A HIGH PACE? IMPACT OF CORONA
- 15. 19 Six major elements were key in the success of this project Change management and training Automated testing Stick to standard Agile project approach THE SIX PILLARS OF THE PROJECT Transformation of master data GxP validation
- 16. 20 1. The scoping: Process model and system overview 2. Process-oriented user requirement specifications 3. Solution design accelerators/gap analysis 4. System documentation, migration and validation 5. Test, training and hypercare 6. Project and change management Agile project management approach: efficient project execution in sprints with fast learning loops. Change management: key focus on process alignment. A successful SAP S/4HANA project approach in life science built around six core elements Sample deliverables Sample deliverablesSample deliverables Sample deliverables Sample deliverables
- 17. 21 ORGANISE TRULY PROCESS ORIENTED Secure business ownership
- 18. Project scope THE END-TO-END PROCESS OVERVIEW Footer Enabling processes Manage warehouse Support QA/QC Master data Product lifecycle maintenance Finance/accounting Reporting Non-functional requirements Indirect procurement Core end-to-end processes Collection and dunning Manage billing and A/R DeliverManage sales orders Manage customer and contract master data, incl. customer credit Pick and pack Sell/deliver: order to cash Invoice receipt and paymentQuality control and release Goods receipt and stock placement Requisitions and procurementSourcing and contracting Source: Procure materials and services Make DS and FG Quality control Warehouse storage Produce productMaterial prepBatch preparation Batch disposition Kanban Plan: Supply chain planning Operational planningMaster planningSales and operations planning Scheduling Source DP and cell bank
- 19. 23Confidential SAP project organisation Warehouse Johnny Olsen (BPO) • Kim Ringby Quality Dea Petersen • Brian Jensen (BPO) • Mads Werenberg (CMO) • Harald Olsen (CLIN) • Luecia Branquinho (Supplier Quality) Master Data Jennifer Santos • Lykke Andersen • Nicolai Lyster • Dorthe Jeppesen (BPO) Finance Jørgen Nielsen (BPO) • Pia Klausen • Jesper Christiansen • Mette Hage • Therese Fabricius • Kieran Punch • John Nymark Jensen Source (direct) Johnny Yu • Eleni Pagoni QC • Lars Pedersen • Bo Overgaard Warehouse • Jed Lurie • Brett Mccubbin Finance • John Nymark Jensen BPO • Gabriella Söderling Plan Thomas Steenholt • Line Harrishøj • Mette Bang BPO • Niklas Garborg Make FG Christian Henriksen • Christina Madsen • Andrew Murray • Pia Pedersen Quality • Dea Petersen • Andreas Nielsen • Bo Overgaaard Compliance • Lars Lundtorp Prep/Review • Eva Jensen • Majbrit Eskildsen Warehouse • Allan Senderovitz Process Science • Martin Vorborg BPO • Lenette Simonsen Make DS Claus Valentiner I&D • Camilla Hansen Man. Doc • Helene Christensen Solution Prep • Jens Brejl Purification • Jesper Meyer Cell culture • Maria A. Zigova Man. Support • Sanne Falsing • Sofie Taylor QC Samples • Henriette Hørbov QA • Keld Siiger • Luna Formsgaard Warehouse • Farshad Sharifzadeh • Brett Mccubbin BPO • Annika Petersen Sell/ Deliver Jed Lurie • Naja Stewart • Marek Kulik • Søren Manniche Warehouse • Brett Mccubbin Finance • Pia Klausen BPO • Susan Døj (BPO) Indirect procurement • Søren Juul • Andreas Barsoe • Therese Fabricius • John Nymark Jensen • Morten Brøndum Pedersen FDB Implement Implema Sub-projects Other external Business Architect Anders Nørtved Process Consultants Anne, Lars, Driton Business Track Leads/Coordinators Business Cutover Manager Palle Gregersen SteerCo Chairman: Christian Houborg FDBD Project Manager Dorthe Jeppesen Jaggaer Project Manager Thomas Søefeldt Batch No. Project Manager Colin Peckett Syncade Project Manager Jakob Helsoe Master Data SME’s S4 Technical Consultants Release Manager Paulius Pakalniskis Technical Cutover Manager Paulius Pakalniskis Analytics Consultant Analytics Project Manager Colin Peckett Integration and Development Consultants QA Validation Mark Lund Business Advisor Preben H. Nielsen IT Project Manager Colin Peckett Training Manager Adam Koziarz Validation Manager Arild Juhl Larsen PMO Support Line Bering Kristensen IT Solution Architect Paulius Pakalniskis Data Migration Manager Arjan Kroonen S4 Project Manager Tonny Kvant Solution Architect Johan Hedlund Project Controlling Kieran Punch Change and Technical Advisory Board Test/Defect Manager Marinus G. Nejrup Data Manager Change Control Heidi Christensen Infrastructure SME + Change Manager Troels Verholt Business SMEs Cutover Coordinator Anders Aalborg Jacobsen Training and Documentation Nina Anker Nissen Data validation and MDM Julie Blom Hansen
- 20. 24 STICK TO STANDARD Implementation partner that knows SAP standard
- 21. 25 8-STEP PROCESS to establish a solid operating model design and high-level scope Operating model Identify key design questions System landscape and integrations Process landscape and application portfolio 1 2 3 4 Key design decision and high-level scope approval Identify relevant SAP best practise Identify and describe GAP to SAP best practice GAP evaluation and rough estimation 8 7 6 5
- 22. 26 SAP is a GAMP 5 and 21 CFR Part 11 compliant system. Thus utilisation of standard is as a starting point low risk. Customisations are high risk and expensive to build and maintain (high LCC). Below-listed method can limit the number of customisations: Process model URS – process flows and detailed descriptions URS – GxP and critical require- ments SAP best practise explorer Design level 1-3 process landscape Identify relevant SAP best practice Design To-Be business processes inspired by SAP best practice Write URS only focusing on GxP and business-critical requirements Evaluate URS delta to best practice and identify GAPs Revisit URS and remove non-critical requirements which lead to GAPs URS CREATION BASED ON SAP BEST PRACTICE
- 23. 27 RISK-BASED APPROACH Validation, test and migration
- 24. Creation and approval of test strategy Risk assessment of requirements and solutions Creation of test cases and detailed test plan Test execution and defect reporting Test execution and defect reporting 1 2 3 4 5 HIGH-LEVEL TEST APPROACH A risk-based approach for testing as an accelerator All end-to-end processes Business process steps for critical core processes Explicit requirements for critical processes SEVERITY * PROBABILITY * DETECTABILITY = RISK PRIORITY NUMBER (RPN)
- 25. No change control Change control User acceptance test Functional test Installation qualification Dry run Informal test of system and verification of test scripts Verification of system installation, configuration and customisation Testing of system functionality, inputting of normal and abnormal test cases according to functional specification Verification of end-to-end processes, work instructions, testing of process flows and descriptions in URS Time Creation and approval of test strategy Risk assessment of requirements and solutions Creation of test cases and detailed test plan Test execution and defect reporting Test execution and defect reporting 1 2 3 4 5 HIGH-LEVEL TEST APPROACH A risk-based approach for testing as an accelerator
- 26. 30 Key elements in an S/4HANA project that must succeed Change management and training Automated testing Stick to standard Agile project approach THE SIX PILLARS OF THE PROJECT Transformation of master data GxP validation