The State Administration for Market Regulation has recently given its nod to and published a pivotal national standard: Implementation Requirements for Good Laboratory Practice - Part 8: Cloud Computing Application in Good Laboratory Practice Test Facilities. This standard is a vital addition to China’s Good Laboratory Practice (GLP) framework, addressing the long-standing need for standardized guidelines on the compliant utilization of cloud computing within GLP laboratories. Its introduction signifies a significant leap forward in the amalgamation of digital transformation and IT advancements within China’s GLP infrastructure.

The standard meticulously outlines the application prerequisites and management protocols for GLP test facilities venturing into cloud computing services. It elucidates the ultimate accountability of test facilities for ensuring GLP compliance, refines the criteria for personnel management, and delineates the computational resource management duties of both test facilities and cloud service providers across three distinct service models. Furthermore, it constructs a comprehensive implementation framework encompassing risk assessment, supplier evaluation, service level agreements, and system validation. Additionally, the standard standardizes exit strategies and electronic archiving protocols.

With the issuance of this standard, China’s existing GLP national standard system is further fortified, bringing it in line with the contemporary benchmarks set by the Organization for Economic Cooperation and Development (OECD). It offers GLP test facilities a robust foundation to safely and compliantly embrace cloud computing technology.