The application of quality risk management to the design, validation and technology transfer of advanced production processes and analytical methods, advanced data analysis methods and computerized systems is important. 将质量风险管理应用于先进生产工艺和分析方法、先进数据分析方法和计算机化系统的设计、验证和技术转移非常重要。--ICH Q9 《风险管理》