期刊名称：Management - Journal of Contemporary Management Issues
印刷版ISSN：1331-0194
电子版ISSN：1846-3363
出版年度：2020
卷号：25
期号：2
页码：1-23
DOI：10.30924/mjcmi.25.2.1
出版社：University of Split, Faculty of Economics
摘要：The purpose of this paper is to present a Quality Management System (QMS) for computer systems validation and to identify and demonstrate the validation process on a practical case of a pharmaceutical company. Based on the European and the US legal requirements, we define QMS for computer system validation elements. Validation process example based on the use of a general V-model provides a thorough understanding of the actual validation implementation in practice. Computer system validation in a concrete organization can be implemented, based on general and specific standard operating procedures which form the QMS. Planning, Specifying, Development/Building, Verification and Report validation activities are presented through process diagrams based on a practical Supervisory Control and Data Acquisition (SCADA) manufacturing computer-aided system validation example. Empirical part employed two research strategies: a single case study and action research. Presented computer system validation QMS and process can provide a guideline for all companies where computer systems are important. Although the presented QMS and process for the computer system validation are related to a specific pharmaceutical company case and its legal requirements, the experience from this highly regulated industry can be appropriately used in other less regulated industries. For verification of the proposed model, they need to be further tested within the pharmaceutical and other less regulated industries.
关键词：Quality Management System; computer systems; validation; V-model; pharmaceutical industry
