A Lean-Guided Approach to MES Integration. A Study at SteelcoBelimed

This thesis explores the implementation of a Manufacturing Execution System (MES) within the OFS workshop of SteelcoBelimed, a leading company in the field of sterilization and infection control solutions. The aim of the project is to improve production process control, traceability and operational efficiency through the digitalization of workflows and real-time data acquisition. The work begins with a comprehensive theoretical framework, presenting the functional role of MES within the ISA-95 architecture, its integration with enterprise systems such as ERP and APS, and its critical importance in highly regulated industries. Special attention is given to the compliance aspects related to FDA 21 CFR Part 11 and EU GMP Annex 11, as well as to the digitalization of electronic batch records (eBR). Following the theoretical foundation, the thesis describes the operational context of the ST-04 plant (where the project was carried out) and provides a detailed analysis of the OFS department, identifying inefficiencies and areas for improvement. The project then applies a structured PDCA (Plan–Do–Check–Act) methodology to guide the design, deployment and validation of the MES solution. Results demonstrate significant improvements in process visibility, documentation accuracy and data integrity, aligning the department with modern Industry 4.0 principles. The final chapter discusses the standardization of the solution and its scalability to other departments and plants within the SteelcoBelimed network.