摘要
在对质量风险管理基本原理与工具的充分理解和分析的基础上,将质量风险管理应用于计算机化系统验证管理,有针对性地提出具体的应用流程。结论:质量风险管理可以应用于计算机化系统整个验证生命周期,并可提升验证的效果和效率。
Based on the understanding and analysis of theories and tools of quality risk management,apply the quality risk management to computerized system validation and propose the specific application flow.Conclusions：Quality risk management can be applied in the whole validation life cycle of computerized system,and the application can raise the effect and efficiency of validation.
关键词
质量风险管理
计算机化系统
验证
Quality Risk Management
Computerized System
Validation
