仪器验证中的设计确认与示例.docVIP

仪器验证中的设计确认与示例 Design qualification (DQ) defines the functional and operational specifications of the instrument and details the conscious decisions in the selection of the supplier . DQ should ensure that instruments have all the necessary functions and performance criteria that will enable them to be successfully implemented for the intended application and to meet business requirements. Errors in DQ can have a tremendous technical and business impact, and therefore a sufficient amount of time and resources should be invested in the DQ phase. For example, setting wrong operational specifications can substantially increase the workload for OQ testing, and selecting a vendor with insufficient support capability can decrease instrument up-time with a negative business impact. “设计确认（DQ）定义了仪器的功能和运行方面的特征值，并详细说明了供应商选择的有意识的判定。”DQ应确保仪器具备所有必须的功能和性能指标，以实现设定的应用要求并满足商业需要。DQ出现错误，会导致技术上和商业上极大的冲击，所以在DQ阶段，须投入充足的时间和资源。例如，运行指标设置的错误会造成OQ阶段工作量的巨增，选择支持能力不足的供应方会导致仪器使用寿命缩短而造成商业冲击。 While IQ, OQ and PQ are being performed in most regulated laboratories, DQ is a relatively new concept to many laboratories. It is rarely performed in those cases where the equipment is planned to be used not for a specific but for multiple applications. 目前，安装确认、运行确认和性能确认已经被大部分控制实验室所应用，而设计确认对于多数实验室却是一个相对较新的概念。当仪器计划应用非单一场合而是多用途时，设计确认应用的少之又少。 Table below lists recommended steps that should be considered for inclusion in a design qualification. 下面各步骤建议包含在设计确认中。 Description of the analysis problem 分析测试问题的描述 Selection of the analysis technique 分析方法的选择 Description of the intended use of the equipment 仪器目标用途的描述 Description of the intended environment 目标使用环境的描述 Preliminary selection of the functional and performance specifications (technical, environmental, safety) 功能和性能指标的预选择（技术的、环境的、安全性） Preliminary selection of the supplier 供应商的预选择 Instrument tests (if the technique is new) 仪器测试（在使用新方法的条件下） Final selection of the equipment 设备的最终选择 Final selection of the supplier 供应商的最终选择 Development and documentation of fin