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GxP Compliance

最后更新时间:2023-01-13 14:28:24

In the healthcare industry, the term GxP encompasses a wide range of compliance-related activities, and it generally refers to a set of regulations, guidelines or industry good practices that regulate the development, manufacturing and sale of medical products such as drugs, medical devices and medical software applications. The"x" in GxP represents a particular field, such as GMP (Good Manufacturing Practice), GAMP (Good Automated Manufacturing Practice), GLP (Good Laboratory Practice), GCP (Good Clinical Practice), etc.

As a global standard, each country or region has its own GxP regulatory agencies and guidelines, such as the "Good Manufacturing Practice for Drugs" by the National Medical Products Administration of China, and the "Title 21 of the Code of Federal Regulations" by the US Food and Drug Administration, and the European Medicines Agency's "EU Good Manufacturing Practice for Medicines", etc. These GxP standards are developed to ensure that medical products maintain the adherence to quality processes at every stage of manufacturing, storage and distribution, and to protect the security of associated data.

The wave of digital transformation in the healthcare industry has driven more and more healthcare institutions to migrate their business systems and data to the cloud. How to ensure the compliance, security and stability of the GxP system on the cloud has also become an important consideration for healthcare institutions on their journey to the cloud. Tencent Cloud aims to explain to customers in the healthcare industry through this GxP compliance white paper:

  • The security responsibilities of Tencent Cloud and customers under the premise of GxP compliance;

  • How Tencent Cloud's quality management system supports the customers‘ systems in compliance with GxP requirements;

  • How Tencent Cloud's management processes and technical measures assist customers in meeting the requirements of GxP computerized systems;

  • For customers' business data hosted on Tencent Cloud, how does Tencent Cloud empower customers to ensure the confidentiality, integrity and availability of their business data;

  • How Tencent Cloud's products and services support customers to improve their GxP compliance capabilities.

If you would like to learn more about Tencent Cloud's GxP compliance white paper, please click here to download the full text of the white paper.

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