Electronic validation systems as an aid to quality and regulatory compliance in the medical device and pharmaceutical industries

Purpose This research examines the current status of the implementation of digitalised validation systems within the Irish Medical Device and Pharmaceutical industries, as well as the benefits of these systems and the experiences of those implementing and using them. Design/methodology/approach Qualitative interviews were conducted with validation professionals and functional stakeholders from a cross-section of Irish pharmaceutical and medical device organisations. Findings Digitalised validation benefits include more sustainable processes with the elimination of paper, a streamlined review and approval process, the successful management of data integrity for large volumes of validation data, reduced document approval times and improved regulatory compliance. The challenges encountered by those who have implemented digitalised validation systems or who are end users of these systems were having adequate training, overcoming resistance to change, upskilling and ensuring good change communication. Research limitations/implications While the study was conducted only in Ireland, as the companies that participated are part of globally based multinationals, thus the study has implications for all regulatory geographies. This study has social implications in demonstrating improved work/life balance via reduced validation administration and enables remote working. It also has sustainability implications and enhances the environment through less paper usage and reduced carbon footprints via the elimination of off-site record storage and the need for employees to be on-site full-time. It allows staff to approve documents electronically and remotely. Enhanced data integrity ensures no adverse patient safety effects. Originality/value This research is the first to investigate the implementation of paperless validation systems in highly regulated industries such as pharma and medtech, specifically focussing on the user experiences of stakeholders involved in these systems and in their implementation, design and ultimate operation. The study demonstrates that the benefits accrued by electronic validation are aligned with global regulatory agencies’ strategy to increase digital innovation and improve patient health and safety.