Industry: Pharmaceutical industry / Active ingredient and contract manufacturing (CDMO)
Role: Project & sub-project management / Lead Consultant & Solution Architect

Siegfried Holding AG, headquartered in Zofingen, Switzerland, is a leading global contract development and manufacturing organisation (CDMO) in the pharmaceutical industry. The company develops and manufactures active pharmaceutical ingredients (APIs) and finished pharmaceuticals for international pharmaceutical and biotech companies. Siegfried combines chemical and pharmaceutical expertise with the highest quality and compliance standards (GxP, FDA, EMA) and operates production sites in Europe, the USA and Asia.

The corporate strategy focuses on global harmonisation, digital excellence and compliance security – particularly in the areas of production, quality and packaging processes.

project objectives

The aim of the project was to introduce a future-oriented SAP S/4HANA-based label management solution to harmonise labelling and packaging processes across all international locations.

The core of the project was the integration of a global label management system based on NiceLabel / Loftware. The aim was to map both regulatory requirements (FDA, EMA, EU MDR) and internal quality and approval processes completely in a GxP-validated framework.

The goal was to achieve centralised, auditable control of all labelling processes, including label approval, versioning and real-time traceability.

Scope of services & tasks

• Project management & solution architecture: Overall responsibility for defining and implementing the SAP-based add-on LBMS label management architecture in an international environment
• Process analysis & business blueprint: Recording existing labelling workflows and creating standardised target processes based on SAP S/4HANA and NiceLabel / Loftware
• Integration & interface design: Design and implementation of interfaces between SAP and the global LBMS label management system via API and TXT-based DevOps connectors
• GxP-compliant system validation: Creation of validation documentation (IQ/OQ/PQ) in accordance with GAMP5 and FDA 21 CFR Part 11
• Customising & process adaptation: Development of individual extensions for the integration of LBMS label approval, material master data, quality and batch information
• Change management & training: training key users and specialist departments, establishing governance structures for sustainable label process control
• Collaboration with global locations: Conducting international workshops (Switzerland, Germany, US, Spain) to ensure a uniform global process standard