Defining user requirement specifications for manufacturing execution system in pharmaceutical industry - A case study for a pharmaceutical company

Abstract

After the pandemic, companies are required to form strategic partnerships and invest in technological advancements to maintain competitiveness. One of the main systems that helps manufacturers advance in their operations is Manufacturing Execution System (MES). Pharmaceutical industry has distinct requirements for computerized systems that involve in the production of medicine, and these requirements include the need to define a complete URS to convey the users’ needs to the system vendors and integrators. Thus, the research questions of the study are: RQ1: What is the method to create a coherent high-level URS for MES? RQ2: What challenges associated with MES implementation should be addressed during URS definition phase?

The research was conducted as single case study with qualitative research method in May- June 2022. Eleven semi-structured interviews with MES stakeholders were carried out according to case study protocol. The main objective was to discover new findings that can contribute to the improvement of current URS definition guidelines as well as identify potential risks associated with industry 4.0 MES implementation. In order to obtain a complete view on URS definition method, the problem was investigated from three perspectives: regulatory, technical and logistical. The study generated twelve propositions on top of current URS definition framework for MES to provide a road map for companies to navigate through MES requirement definition phase.