Requirements engineering practice in pharmaceutical and healthcare manufacturing

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.