en.Wedoany.com Reported - Recently, the State Administration for Market Regulation approved and released the national standard "Requirements for the Implementation of Good Laboratory Practice - Part 8: Application of Cloud Computing in Good Laboratory Practice Test Facilities." This standard is an important component of China's Good Laboratory Practice series standards, filling the gap in the application of cloud computing technology in the compliant use of GLP laboratories in China, marking a new stage of digital transformation and information technology integration in the construction of the GLP system.
GLP laboratories undertake safety evaluation and non-clinical research tasks for pharmaceuticals, chemicals, pesticides, and food-related products. The authenticity, integrity, traceability, and long-term preservation capability of test data are directly related to regulatory acceptance. In the past, laboratory information systems were more often deployed in local computer rooms or closed network environments, where data management boundaries were relatively clear. With the accelerated application of cloud computing, remote collaboration, electronic archives, laboratory information management systems, and data backup services, test facilities, while enjoying the benefits of elastic resources and system operation convenience, also face new issues such as responsibility division, supplier management, system validation, data migration, and service exit. The release of the new national standard provides a clearer compliance basis for cloud services entering the GLP environment.
The standard clarifies that GLP test facilities bear the non-transferable ultimate responsibility for GLP compliance. That is, even if some computing resources, storage services, or software capabilities are supported by cloud service providers, the test facility remains responsible for the research process, raw data, electronic records, archive preservation, and quality assurance activities. The standard also details the management requirements for facility management, system administrators, archive managers, and quality assurance personnel in the cloud environment, preventing the blurring of responsibility chains due to system outsourcing or platform migration to the cloud.
In terms of technical and management frameworks, the standard covers three cloud service models: Infrastructure as a Service, Platform as a Service, and Software as a Service. It defines the attribution of resource management responsibilities between test facilities and cloud service providers, and establishes implementation requirements for risk assessment, supplier evaluation, service level agreements, and system validation. For GLP laboratories, compliant application of cloud computing is not simply purchasing cloud servers or cloud software, but rather integrating service selection, contract agreements, permission control, data backup, audit trails, change management, system validation, exit strategies, and electronic archiving into a full lifecycle management process. The standard also sets requirements for the complete archiving and secure migration of data upon service termination or system retirement, preventing the loss, unreadability, or untraceability of critical test data due to platform switching or service cessation.
This standard will influence the future development paths of cloud service providers, laboratory information system vendors, testing and certification bodies, and GLP test facilities. Cloud platforms need to provide security, auditing, backup, access control, and service continuity capabilities that better meet regulatory requirements. LIMS, electronic laboratory notebooks, archive management, and quality management systems need to align with data integrity requirements in the cloud environment. Test facilities need to reassess their existing information systems and external service contracts. As the digitalization of pharmaceutical R&D, chemical safety evaluation, and third-party testing services increases, the migration of GLP laboratories to the cloud will transition from individual exploration to standardized application with regulatory constraints, providing more stable support for the digitalization of Chinese laboratories and the trusted flow of regulatory data.
This article is compiled by Wedoany. All AI citations must indicate the source as "Wedoany". If there is any infringement or other issues, please notify us promptly, and we will modify or delete it accordingly. Email: news@wedoany.com
