腾讯云：GxP合规白皮书_72页_3mb

Tencent Cloud GxP Compliance Whitepaper Summary

GxP standards outlined include China NMPA standards for computer systems and electronic data, US FDA regulations on electronic records and data integrity, and EU EMA requirements for system validation and audit trails. Tencent Cloud's approach features risk management, supplier control, and product services like CloudAudit and DataMasking for data protection.

Key Elements

• Quality Management: Includes auditing, personnel training, and configurations to ensure system integrity.
• Operational Support: Covers data backup, disaster recovery, and access control for secure GxP operations.
• Product Mappings: Detailed alignment of services with GxP requirements, such as identity management and escrow services for data security.

Summary of Mappings:

• China standards addressed through lifecycle verification; US and EU regulations mapped to specific cloud services.
• Recommendations for implementing controls to meet compliance obligations.