New national standard released: Filling in the blank of standards for the compliant application of cloud computing in GLP laboratories in China.

The General Administration of Market Supervision recently approved the release of the national standard "Implementation Requirements for Good Laboratory Practice Part 8: Application of Cloud Computing in Good Laboratory Practice Testing Institutions." This standard is an important part of the series of standards for good laboratory practice in China, filling the standard gap in the compliance application of cloud computing technology in GLP laboratories in China, marking a new stage in the digital transformation and integration of information technology in the construction of the GLP system in China. The standard systematically specifies the application requirements and management guidelines for GLP testing institutions when introducing cloud computing services. Firstly, it clarifies that testing institutions bear the ultimate responsibility for GLP compliance, and elaborates on the specific management requirements for institution managers, system administrators, record keepers, and quality assurance personnel in a cloud environment. Secondly, it defines in detail the management responsibilities for computing resources between testing institutions and cloud service providers under the three service models of "Infrastructure as a Service," "Platform as a Service," and "Software as a Service," ensuring a clear and traceable chain of responsibility. Thirdly, it establishes an implementation framework covering risk assessment, supplier evaluation, service level agreements, and system validation, providing full-process compliance guidance from selecting cloud services, signing agreements, to system retirement. Fourthly, it standardizes exit strategies and electronic archiving requirements to ensure that data can be fully archived or securely migrated when cloud services are terminated or systems are retired. The implementation of this standard is a supplementary and perfecting to the existing national standard system for GLP in China, ensuring that the technical requirements for GLP and the latest requirements from international economic cooperation and development organizations remain coordinated, providing standardized support for ensuring the safety and compliance of GLP testing institutions when introducing cloud computing technology.