Deploying Containerized Microservices in on-Premise Kubernetes Environments: Challenges and Best Practices

Abstract

Change control processes are critical in regulatory affairs to ensure compliance with evolving regulations and maintain product quality and safety. This comprehensive study examines the current challenges in change control processes within the pharmaceutical and medical device industries, and proposes best practices for streamlining these processes. Through an analysis of industry data, expert interviews, and multiple case studies, we identify key strategies for improving efficiency, reducing approval times, and enhancing overall compliance. The research highlights the importance of risk-based approaches, digital transformation, and cross-functional collaboration in optimizing change control processes. Our findings provide valuable insights for regulatory affairs professionals and organizations seeking to enhance their change management capabilities in an increasingly complex regulatory landscape.