Industry: Life sciences / medical technology
Role: Project management & solution architect / SAP senior consultant
Sequana Medical NV, based in Ghent, Belgium, is a leading medtech company specialising in innovative solutions for the treatment of chronic fluid accumulation in patients with liver disease, heart failure and cancer. With the development of the Alfapump® system, an implantable pump for automatic fluid drainage, Sequana combines medical technology, data integration and digital monitoring.
The company operates in the highly regulated GxP environment and is subject to stringent requirements for quality, traceability and system validation in accordance with FDA 21 CFR Part 11 and EU MDR.
The aim of the project was to introduce SAP S/4HANA as the central enterprise platform for production, quality, logistics and compliance. The focus was on establishing a validated, GxP-compliant system landscape that digitally maps both internal processes and the integration of R&D, production and the supply chain. The project was carried out as an S/4HANA greenfield implementation in accordance with the SAP Activate methodology.
- Presales & Strategic Planning:
- Support with project definition, cost estimation and business case creation for the introduction of SAP S/4HANA
- Project management & solution architecture:
- Responsibility for the design and implementation of the SAP system architecture with a focus on MM, PP-PI, WM, QM, FI/CO, SD
- Process consulting & BBP creation:
- Conducting business blueprint workshops to define GxP-compliant core processes
- S/4HANA Greenfield implementation:
- Implementierung nach SAP Activate (Phasen: Discover – Prepare – Explore – Realize – Deploy)
- GxP process validation & documentation:
- Creation of validation concepts, SOPs, IQ/OQ/PQ documentation to ensure regulatory compliance
- SAP Customizing & Integration:
- Development of material and manufacturing processes with links to quality management and warehouse logistics (WM)
- System validation & audit trail management:
- Support with system checks, traceability analyses and audit preparations
- Change Management & Training:
- Training of key users and specialist departments with regard to GxP-compliant working in SAP
- Strict GxP and MDR regulations in medical technology with high requirements for documentation and traceability
- Necessity of a validated SAP system in a regulated environment
- Integration of R&D, production, quality and warehouse logistics in a harmonised process landscape
- Parallel operation of legacy systems during greenfield implementation
- Ensuring auditability and data integrity for FDA and EU inspections
- Implementation of an SAP S/4HANA core architecture for production, logistics, quality and materials management
- Definition and implementation of a GxP-compliant validation framework in close coordination with QA & Compliance
- Introduction of a process-based structure for batch and serial number management
- Use of SAP QM for automated recording, checking and documentation of quality characteristics
- Establishment of an integrated material flow chain from production to delivery
- Introduction of a change control system for regulatory tracking and system approval
- Creation of a global process model for future rollouts and scaling
- GxP-validated SAP S/4HANA landscape with complete traceability of all production and quality data
- Increased process reliability and data integrity through clear role and approval structures
- Standardisation of the system landscape as a basis for growth and regulatory audits
- Digital transparency across R&D, production and logistics
- Reduction of manual documentation through integrated electronic testing and approval processes
- Future-proof foundation for international expansion and integration of additional locations