Digitalisation of quality systems

Abstract

Advancements in technology contribute towards fundamental developments in digital strategies, and core processes at an entrepreneurship level. The objectives of this study are to (i) compare the level of digitalisation of quality systems across European Medicines Regulatory Authorities (EMRA), (ii) identify through a gap analysis the requirements for the implementation of a digitalised management system (QMS), and (iii) determine the benefits, opportunities, and challenges of digitalisation within quality systems. The method undertaken is composed of two phases. Phase 1 includes the development, validation, and dissemination of a survey. The validation process was carried out by a focus group. The survey ‘Quality Management, Big Data, and Digitalisation Analysis’ consists of three parts: Part A – Participant Demographics, Part B – Analysis of the QMS and the organisational approach, and Part C –Analysis of big data and digitalisation at the EMRA. Phase 2 presents the process of analysis of the survey responses, to identify best practices of digitalisation in the context of QMS in the pharmaceutical regulatory field. The dissemination of the results includes preparing a PowerPoint Presentation at a Quality Managers Working Group meeting. Twenty-six European countries successfully enrolled to the validated survey. The level of digitalisation of QMS in EMRA (n=29) is analysed through the attitude towards new technologies which rated as 2 very good, 8 good, 17 fair, 2 poor; and through the integration of digital technology which rated as 8 very good, 11 good, 10 fair. The requirements for the implementation of a QMS were identified to be documents management (4.5), shared database (4.3), and access control (4.3). The highly quoted benefits of digitalisation within the QMS were enhanced data management (4.3), improved productivity (4.3), and increased transparency (4.3). The challenges were determined to be collection and integration of data from widely distributed data sources (4.1) and discovering large volume of data to extract useful information (4.1). The opportunities are considered to be improved decision-making (4.3) and consolidated operations (4.1). It is concluded that there is hesitation in the concept of merging new technologies in a regulatory agency, however as rated by the positive feedback towards integration and attitude towards new technologies, digital initiatives are feasible. The tangible value of digitalisation can be accomplished through organisational commitment and support by human expertise.