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The overall approach is based upon the “Life Cycle”or”V Model” for commissioning and qualification.The intent is to focus on the user requirements and up-front preliminary engineering so that the corresponding critical attributes of the equipment and system are defined.These attributes will be the basis for the testing procedures and respective acceptance criteria used in the commissioning and qualification activities.As part of this early engineering planning phase equipmnt and system provider activities,reviewed with the intent of”leveraging”the system providers, knowledge of the equipment/system,their quality practices in the design and build of the system, their support of FAT activities ,their installation and start-up expertise,their support of commissioning and SAT activities,and their qualification support.A number of the these activities will be monitored,reviewed,witnessed,and documented with the intent of reducing redundant testing during qualification. In addition,this will provide for a higher level of assurance that the equipment andsystems have been developed,built,installed and operate in accordance with pre-defined requirements. |
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谁有人卫版 《毒理学基础》第七版书籍
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