风险评估在新建暖通空调计算机化系统验证中的应用

Application of Risk Assessment in Validation of Newly Constructed HVAC Computerization System

制药企业计算机化系统验证范围与深度如果合适则可以为用户节省不必要的消耗,节约成本。如何在药厂新建洁净暖通空调计算机化控制系统中应用风险评估方法确定验证范围与验证深度,从而优化验证过程。

The appropriate validation scope and depth for computerized system used in pharmaceutical enterprises can save unnecessary consumptions for the users. In this article, the application of risk assessment methods in newly constructed cleaning HVAC computerization system to determine the scope and depth of the validation and to optimize validation process was expounded.