Determinants and impacts of computer system validation on firm-level performance

Abstract

Purpose. Amendments to regulatory directives in the medical device industry are forcing manufacturers to constantly review and adapt their business processes. In this context, the current focus is on computer system validation (CSV). The aim of this research is to identify determinants and impacts of CSV on firm performance and to determine the associated challenges, especially for
small and medium-sized enterprises (SMEs).

Design/methodology/approach. A structured literature review was carried out which analyses published studies, evaluates contributions, and summarises knowledge. For this purpose, a previously developed research model served as the basis for data collection.

Findings. A total of 233 research papers were examined and divided into different categories and classified according to different criteria. Most of the research papers are grounded on a resourcebased approach and predominantly investigate the impact of IT resources or capabilities on firm performance. Moreover, the review reveals that no research could be identified that justified
changes in firm performance due to the implementation of CSV.

Research limitations/implications. The results of this paper can only be generalized to the specific population of scientific publications within the selected literature databases. Implications for future research are suggested.

Originality/value. The findings are derived from an exhaustive literature review of quantitative and qualitative studies. Thus, this research serves as a theoretical foundation for the investigation of change in firm performance as a result of IT resources and the mediator role of CSV and provides a path for future research for this field of study.