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https://doi.org/10.30924/mjcmi.25.2.1

Computer system validation: Example of quality management system design and process implementation

Borut Rusjan ; University of Ljubljana, School of Economics and Business, Ljubljana, Slovenia

Puni tekst: engleski, pdf (688 KB) str. 1-23 preuzimanja: 1.518* citiraj
APA 6th Edition
Rusjan, B. (2020). Computer system validation: Example of quality management system design and process implementation. Management, 25 (2), 1-23. https://doi.org/10.30924/mjcmi.25.2.1
MLA 8th Edition
Rusjan, Borut. "Computer system validation: Example of quality management system design and process implementation." Management, vol. 25, br. 2, 2020, str. 1-23. https://doi.org/10.30924/mjcmi.25.2.1. Citirano 24.10.2021.
Chicago 17th Edition
Rusjan, Borut. "Computer system validation: Example of quality management system design and process implementation." Management 25, br. 2 (2020): 1-23. https://doi.org/10.30924/mjcmi.25.2.1
Harvard
Rusjan, B. (2020). 'Computer system validation: Example of quality management system design and process implementation', Management, 25(2), str. 1-23. https://doi.org/10.30924/mjcmi.25.2.1
Vancouver
Rusjan B. Computer system validation: Example of quality management system design and process implementation. Management [Internet]. 2020 [pristupljeno 24.10.2021.];25(2):1-23. https://doi.org/10.30924/mjcmi.25.2.1
IEEE
B. Rusjan, "Computer system validation: Example of quality management system design and process implementation", Management, vol.25, br. 2, str. 1-23, 2020. [Online]. https://doi.org/10.30924/mjcmi.25.2.1

Sažetak
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.

Ključne riječi
Quality Management System; computer systems; validation; V-model; pharmaceutical industry

Hrčak ID: 247329

URI
https://hrcak.srce.hr/247329

Posjeta: 1.812 *