Title :
Requirements engineering practice in pharmaceutical and healthcare manufacturing
Author :
Sudeep Prakash ; Aurum, A. ; Cox, Karl
Author_Institution :
CSE, New South Wales Univ., Sydney, NSW, Australia
fDate :
30 Nov.-3 Dec. 2004
Abstract :
With the growing demand for pharmaceutical and healthcare products worldwide, we examine requirements engineering (RE) process practices in three multinational pharmaceutical and healthcare companies in Australia. We found there were large differences in the processes used between companies in the production of similar products and that none of the projects followed the recommended best practice RE process model for this industry. We found that a number of implicit activities were being conducted as part of the project process. Within this life critical domain this is not to be recommended. Thus we highlight the need to more closely align recommended best practice with actual practice through the employment of a standardised and explicit RE process for developing mission and safety-critical systems in pharmaceutical and healthcare manufacturing.
Keywords :
formal specification; formal verification; health care; pharmaceutical industry; safety-critical software; healthcare manufacturing; pharmaceutical product; requirements engineering; safety-critical system; Australia; Best practices; Drugs; Economic forecasting; Hospitals; Manufacturing processes; Marketing and sales; Medical services; Pharmaceuticals; Software systems;
Conference_Titel :
Software Engineering Conference, 2004. 11th Asia-Pacific
Print_ISBN :
0-7695-2245-9
DOI :
10.1109/APSEC.2004.86