Industry: Life sciences / medical technology
Role: Project management & solution architect / SAP senior consultant
INTEGRA Biosciences AG, headquartered in Zizers, Switzerland, is a leading international company in the field of laboratory automation and liquid handling systems. The company develops and manufactures high-precision pipetting and dispensing systems that are used worldwide in research, diagnostics, biotechnology and the pharmaceutical industry. INTEGRA pursues a clear digitalisation strategy to seamlessly connect processes from research and development (R&D) to production, quality assurance and distribution.
The focus is on implementing a GxP-compliant SAP S/4HANA system landscape that combines innovation, scalability and regulatory security.
The aim of the project was to introduce SAP S/4HANA as the central ERP and production platform as part of a greenfield implementation, including full integration of production, quality and logistics processes in accordance with GxP standards. At the same time, the foundations for a digital supply chain were to be laid and the process landscape standardised in accordance with the SAP Activate method.
- Presales & Strategic Project Preparation:
- Analysis of the existing system landscape and creation of an implementation concept, including cost estimate and business case
- Project management & solution architecture:
- Overall responsibility for the design and implementation of the S/4HANA system architecture (MM, PP, PP-DS, EWM, QM)
- Team management & customer responsibility:
- Management of interdisciplinary project teams and direct contact person for all SAP-related issues
- S/4HANA Greenfield implementation:
- Umsetzung nach der SAP Activate Methodik (Prepare – Explore – Realize – Deploy)
- Process analysis & business blueprint:
- Definition of standardised core processes in production, quality management and warehouse logistics
- GxP-compliant system validation:
- Development and documentation of validation processes (IQ/OQ/PQ), including creation of SOPs, audit trails and test plans
- Integration PP-DS & EWM:
- Fine-grained production planning with PP-DS and integration of SAP Extended Warehouse Management for warehousing and shipping processes
- SAP Customising & Specifications:
- Development of customised solutions and add-ons for mapping specific life science processes
- Change Management & Training:
- Introduction of a structured change control process and training of key users and specialist departments
- Establishment of a fully GxP-validated system landscape during ongoing operations
- Ensuring integration between PP-DS, QM and EWM in real time
- Compliance with strict regulatory requirements (EU MDR, FDA 21 CFR Part 11)
- Transformation of a historically grown IT landscape into a modular, standardised S/4HANA system
- Harmonisation of development, manufacturing and distribution processes across multiple international locations
- Implementation of a modular SAP S/4HANA greenfield architecture with a focus on digital manufacturing and quality excellence
- Introduction of PP-DS for precise production control based on capacity, material availability and prioritisation
- Integration of EWM (Extended Warehouse Management) for seamless connection between production and logistics
- Establishment of a GxP-compliant validation framework with IQ/OQ/PQ verification
- Use of the SAP Activate methodology for transparent project management and controlled implementation phases
- Development of specific interfaces (API, IDoc, RFC) for connecting external systems and production facilities
- Establishment of a process monitoring structure for real-time monitoring of manufacturing and testing processes
- Digital, end-to-end process chain from product development to manufacturing and delivery
- Validated and auditable SAP system landscape with full compliance
- Increased planning reliability and resource efficiency through integration of PP-DS
- Reduction of manual effort through automated quality and storage processes
- Improved transparency and traceability throughout the entire supply chain
- Skalierbare Basis für internationale Expansion und zukünftige SAP-Rollouts