Dr. Mitja Cerovšek, univ. dipl. inž., Iskra PIO, d. o. o., Šentjernej,
Kristian Peklaj, mag. inž., Novartis, d. o. o., Ljubljana

Abstract​:
The validation of computerized systems in the pharmaceutical industry is increasingly complex due to the rapid advancement of digital technologies. Ensuring compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and data integrity (DI) standards requires structured documentation and adherence to regulatory guidelines, such as GAMP 5. This study explores the leveraging method to optimize validation efforts, reduce redundant testing, and streamline compliance. It also examines the impact of modern technologies, including artificial intelligence (AI), machine learning (ML), blockchain, and cloud computing, on validation processes. The findings highlight both the challenges and opportunities these technologies present in enhancing efficiency, automation, and data security within Pharma 4.0. Ultimately, the research underscores the need for structured, traceable documentation and risk-based approaches to ensure regulatory compliance in an evolving digital landscape.

Keywords:
Computerized system validation, pharmaceutical industry, GAMP 5, data integrity, regulatory compliance, AI, machine learning, blockchain, cloud computing, Pharma 4.0.