Automating Computer Software Validation in Regulated Industries with Robotic Process Automation

Computerized System Validation (CSV) aims to ensure that software systems in regulated environments, such as the pharmaceutical industry, adhere to strict regulatory requirements. It plays a crucial role in guaranteeing the safety of products or services by verifying that computerized systems operate according to the specified guidelines. However, CSV is a complex and resource-intensive process that poses challenges for small and medium-sized enterprises in particular, making it challenging to be implemented effectively. In this paper, we investigate the potential of Robotic Process Automation (RPA) as a solution to partially automate CSV and address these challenges. We present an ongoing project where we apply RPA to CSV and discuss its effectiveness in reducing the time and effort associated with manual CSV activities. We also describe the challenges that we encountered during the implementation of RPA in the context of CSV. Our research highlights the possibility of extending the application of RPA beyond simple data entry and verification tasks, allowing for the automation of entire complex processes.