Profiling of Software Requirements for the Pharmaceutical Enterprise Manufacturing Execution System

This chapter is devoted to analysis of existing Pharmaceutical Enterprise (PE) Manufacturing Execution System (MES) requirements. A special technique grounded on so-called Semantic Facet-Hierarchical Structures (SFHS) is suggested for the requirements profiling, development of general and particular PE MES requirements profiles taking into account software requirements of ISO/IEC 25010 “Systems and software—Systems and software Quality Requirements and Evaluation (SQuaRE)—System and software quality models” and GAMP “Good Automated Manufacturing Practice” standards. The chapter has the following structure: the Sect. 1 introduces into problem, the Sect. 2 describes features of PE and MES and corresponding standards, the Sect. 3 is dedicated to the SFHS-based technique analysis, the Sect. 4 presents case study and last one concludes and discusses future works.