The increasing global threats caused by a prohibited trade of counterfeit pharmaceutical goods encourage countries around the world to gradually apply a set of global standards and provisions that could play a vital role in counterbalancing and thus eliminating the problem. The purpose of this Master's thesis is to provide a conceptual systematic presentation of the actual global serialization and traceability requirements in pharmacy and therefore show how to introduce a sustainable and efficient IT system meeting all the demands from the perspective of a manufacturing pharmaceutical company using a practical example. To support the complex decision-making of the best fit solution for our implementation from a set of possible traceability solution systems, the computer program designed for multi-attribute decision making DEXI was used. The SAP Aii/OER traceability solution was selected as the most suitable one and therefore all the aspects of the architectural design comprise SAP as a central component and an interface of the architectural installation. To ensure a holistic approach to the analysis and visualization of the pharmaceutical company business process, the Archimate tool was applied as an enterprise architecture modelling language. The Archimate presentation encompassed the enterprise, application and technical levels. The results of the preparation conducted showed the practical implementation of the SAP Aii/ OER system through the use of ASAP methodology considered as a standard approach in the field of the AS systems. To substantiate the thesis, practical examples of the implementation were included demonstrating the SAP Aii/OE platform. The thesis results in a new and well-functioning integrated SAP Aii/OER system within the SAP ECC environment.
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