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

Rusjan, Borut (author)

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.

• Language: English
• Keywords: management, business process, information systems
• Work type: Article
• Typology: 1.01 - Original Scientific Article
• Organization: EF - School of Economics and Business
• Publication version: Version of Record
• Year: 2020
• Number of pages: Str. 1-23
• Numbering: Vol. 25, iss. 2
• PID: 20.500.12556/RUL-124379
• UDC: 005.3
• ISSN on article: 1331-0194
• DOI: 10.30924/mjcmi.25.2.1
• COBISS.SI-ID: 44507139
• Publication date in RUL: 19.01.2021

Record is a part of a journal

• Title: Management. journal of contemporary management issues
• Shortened title: Management
• Publisher: Sveučilište u Splitu, Ekonomski fakultet
• ISSN: 1331-0194
• COBISS.SI-ID: 3757084

Licences

• License: CC BY-ND 4.0, Creative Commons Attribution-NoDerivatives 4.0 International
• Link: http://creativecommons.org/licenses/by-nd/4.0/
• Description: Under the NoDerivatives Creative Commons license one can take a work released under this license and re-distribute it, but it cannot be shared with others in adapted form, and credit must be provided to the author.
• Licensing start date: 19.01.2021

Secondary language

• Language: Croatian
• Title: Validacija računalnog sustava: primjer upravljanja dizajna sustava upravljanja kvalitetom i procesne implementacije

Abstract

Cilj ovog rada je prezentacija sustava upravljanja kvalitetom (Quality Management System - QMS) za validaciju računalnih sustava te prikaz validacijskog procesa na praktičnom slučaju farmaceutske tvrtke. Na temelju europskih i američkih pravnih zahtjeva, definiramo QMS za validaciju elemenata računalnog sustava. Primjer procesa validacije, zasnovan na korištenju općeg V-modela, pruža detaljno razumijevanje praktične implementacije validacije u praksi. Validacija računalnog sustava u konkretnoj organizaciji može se temeljiti na općim i specifičnim standardnim operativnim procedurama, koje formiraju QMS. Validacijske aktivnosti planiranja, specificiranja, razvoja/izgradnje, verificiranja i izvještavanja se prezentiraju korištenjem procesnih dijagrama, zasnovanih na praktičnom primjeru validacije računalnog sustava za upravljanje proizvodnjom Supervisory Control and Data Acquisition (SCADA). Empirijski dio rada koristi dvije istraživačke strategije: studiju slučaja i akcijsko istraživanje. Predstavljeni procesa validacije, kao i primjer računalnog sustava za upravljanje kvalitetom mogu pružiti smjernice za sva poduzeća, kojima su računalni sustavi značajni. Iako se prezentirani QMS i proces validacije računalnog sustava zasnivaju na primjeru konkretnog farmaceutskog poduzeća i njegovih pravnih zahtjeva, iskustva iz visoko regulirane industrije se mogu na odgovarajući način koristiti i u manje reguliranim industrijama. Za verifikaciju predloženog modela, potrebno ih je dalje testirati, kako u farmaceutskim, tako i u drugim, manje reguliranim industrijama.

• Keywords: sustav za upravljanje kvalitetom, računalni sustavi, validacija, V-model, farmaceutska industrija