CLOUD COMPLIANCE INTELLIGENCE FRAMEWORK FOR GXP VALIDATION IN LIFE SCIENCES

Abstract

The emergence of cloud computing has radically changed the technological foundation of the life sciences industry. But with this digital transformation comes the issues of ensuring regulatory compliance in very tightly regulated settings, particularly in the framework of Good x Practice (GxP). The conventional methods of computer system validation are not able to cope with the dynamic, scalable and distributed characteristics of cloud technologies. This paper suggests and develops the idea of a Cloud Compliance Intelligence Framework (CCIF) based on GxP validation in life sciences. It assesses the structural and functional aspects of the framework, deals with regulatory and data integrity issues, and describes how the intelligent automation and risk-based compliance strategies can streamline the validation processes. It is argued in the paper that properly designed CCIF can be a scalable and auditable system to maintain the existing GxP compliance, even in the changing cloud-based platforms.