Assessment of the Implementation of a Cloud-Based Software Solution for Drug Registration at a Pharmaceutical Company

Abstract

This comprehensive research delved into the impact of implementing a cloud- based Regulatory Information Management software solution on the efficiency of drug registration processes within a pharmaceutical company. The study was guided by the hypothesis that the adoption of such a cloud-based solution significantly enhances efficiency by reducing time costs, boosting productivity, and fostering collaboration among cross-functional departments. Employing a mixed-methods parallel design approach, the research gathered quantitative data by means a survey administered to employees of a pharmaceutical company who are involved in drug registration processes utilizing the implemented software solution, and qualitative data through interviews with key stakeholders in managerial positions directly engaged in drug registration processes at the company. There were 52 respondents to the survey and 10 interviews were conducted providing an adequate representation of the population involved in drug registration processes at the company. Data analysis, comprising descriptive statistics, thematic analysis, and cross- case comparisons, uncovered patterns, challenges, and benefits. The analysis reveals that the implementation of cloud-based software for drug registration processes would lead to operational efficiencies and positively influences the various functions involved in producing a drug registration dossier and enhances the drug registration processes despite the variations in satisfaction levels and challenges in user adaptation.

The findings contribute valuable insights into the effectiveness of cloud-based software solutions in improving drug registration efficiency, offering evidence- based recommendations for pharmaceutical companies aiming to optimize their processes through cloud-based technologies. Key recommendations include the need for continuous training and support programs and customization to meet evolving business requirements