Description des bonnes pratiques à respecter et des aspects de validation dans le cadre de la mise en place d'un ERP dans une société pharmaceutique

Abstract

NSI IT Software and Services, a Liège-based company active in the IT service sector, and more particularly its AX unit, has been experiencing significant demand from various pharmaceutical companies for several years. These companies are asking for ERP software to facilitate their daily management. As an integrator of the Microsoft Dynamics 365 for Finance and Operations (D365 F&O) ERP, NSI offers them this solution configured according to the needs of pharmaceutical customers. However, in its standard version, it does not fully meet these particular needs. Indeed, the pharmaceutical industry requires many sector-specific functionalities that are not present in D365 F&O. This is why, on the strength of its experience and a common need to these companies, NSI has decided to develop a pharma package in D365 that closes the gaps with the standard package. In the interests of quality and patient safety, the pharmaceutical industries are extremely controlled and therefore subject to a large number of standards that regulate the way in which companies must set up their activities in order to produce quality medicines, which will then be authorised to be placed on the market. It is therefore necessary for the pharma package developed by NSI to comply with these standards. The aim of this project-thesis is therefore to provide an external point of view on this new pharma package and to assist in its development in compliance with the specific constraints imposed on this sector. Firstly, this thesis presents an analysis of the functionalities present in the package and verifies that they correspond to the pharmaceutical requirements. New functionalities are also proposed in order to complete the package. Secondly, the emphasis is placed on the methodology to be adopted during the development of computerised systems used in the pharmaceutical sector. After presenting the V cycle, the recommended method, an analysis of the methodology currently used by NSI for the development of its pharmaceutical projects was carried out. Finally, this thesis presents some recommendations to be implemented in order to improve the methodology used by NSI in its pharmaceutical projects so that it corresponds to the sector's requirements as much as possible.