Title :
Profiling of MES software requirements for the pharmaceutical enterprise
Author :
Fedoseeva, A. ; Kharchenko, V.
Author_Institution :
Nat. Univ. of Pharmacy, Kharkiv, Ukraine
Abstract :
Approach to safety assessment for manufacturing execution systems (MESs) of pharmaceutical enterprise based on the Safety Case methodology is proposed. Normative profile for MES software based on requirements of international standards, guidelines and technical reports of the pharmaceutical enterprise (PE) and general requirements to critical software is developed. The facet-hierarchical structure of requirements to the PE MES software is suggested.
Keywords :
formal specification; pharmaceutical industry; program diagnostics; safety-critical software; PE-MES software requirement profiling; critical software; facet-hierarchical structure; general requirements; international guidelines; international standards; manufacturing execution systems; normative profile; pharmaceutical enterprise; safety assessment; safety case methodology; technical reports; Drugs; Industries; Safety; Software; Standards;
Conference_Titel :
Design & Test Symposium (EWDTS), 2014 East-West
Conference_Location :
Kiev
DOI :
10.1109/EWDTS.2014.7027090
