Software assessment under consideration of validation aspects: PPS and PMS systems.

Due to safety aspects, business risks and regulations of the FDA [FDA, 1983, Guide to Inspection of Computerized Systems in Drug Processing. USA] and the EU [EU-Leitfaden einer Guten Herstellpraxis for Arzneimittel, 1989, III/2244/87 Rev. 3. Jan. 1989], computer based systems used in the pharmaceutical production have to be validated. In this paper we assessed which modules of production planning and control (PPS) and production management systems (PMS) have to be validated using a risk analysis procedure. It could be shown that the necessity of the validation concerns, above all, the modules of production management systems. Furthermore, a software supplier questionnaire was developed according to the V-model of Royce [National Computing Centre, 1989. STARTS Publications, UK.]. The software supplier questionnaire was applied on four software products, which are mostly used in the pharmaceutical industry. Although these were developed according to a life cycle concept they fulfil the validation requirements, measured with the developed questionnaire, to a different degree. Especially the key element of the risk analysis was differently interpreted.