Abstract
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.
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Kharchenko, V., Gordieiev, O., Fedoseeva, A. (2016). Profiling of Software Requirements for the Pharmaceutical Enterprise Manufacturing Execution System. In: Bris, R., Majernik, J., Pancerz, K., Zaitseva, E. (eds) Applications of Computational Intelligence in Biomedical Technology. Studies in Computational Intelligence, vol 606. Springer, Cham. https://doi.org/10.1007/978-3-319-19147-8_4
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DOI: https://doi.org/10.1007/978-3-319-19147-8_4
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