Electronic validation systems to improve regulatory compliance within the medical device and pharmaceutical manufacturing industries-A survey

The purpose of this research was to examine the current status of the implementation of digitalized 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. A quantitative survey was conducted with Validation professionals and functional stakeholders from a cross-section of Irish Pharmaceutical and Medical Device organizations. Digitalized validation systems have benefits, and these are well-recognised by those in the industry. There is support for transitioning to these systems. These benefits include having a more sustainable process 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 digitalized validation systems or who are end users of these systems were having adequate training and overcoming resistance to change, upskilling and ensuring well-managed change communication. The studies’ learnings can be leveraged across industries, having theoretical implications in adding to the sparse e-validation literature and contributions to the limited literature on e-validation, particularly in highly regulated manufacturing sectors. The integration of industry perspective strengthens its empirical value and relevance with Industry 4.0, Quality 4.0, and regulatory compliance frameworks.