1.0 Definitions定义1.1 Direct Impact System: A system that is expected to have a direct impact to the “product,” on theenvironmental conditions within critical rooms or chambers, and/or the impact on the integrity of the GxP documentation. These systems are designed and commissioned in line with GoodEngineering Practice (GEP). In addition, Direct Impact Systems are subject to QualificationPractices.直接影响系统：预计对“产品”有直接影响的系统，影响到重要房间或功能间的环境条件，及对GxP 文件的完整性有影响的系统。
这些系统的设计和调试符合GEP。
另外，对直接影响系统需要进行确认活动。
1.2 No Impact System: A system that will not have any impact, either directly or indirectly, tothe “product”, the environmental conditions within critical rooms or chambers, and/or the integrity of the GxP documentation. These systems are designed and only commissioned following GEP.无影响的系统：对“产品”、重要房间或功能间的环境条件或GxP文件的整体性既无直接又无间接影响的系统。
这些系统仅需按照GEP要求设计并调试。
1.3 System Impact Assessment (SIA): A system level assessment to identify which systemshave direct impact on product quality or process performance. Those that have direct impact are subject to commissioning and qualification, while those that do not or have non-direct impact are subject to commissioning only.系统影响性评估(SIA):对哪些系统在产品质量或工艺性能上有直接影响的系统评估。
有直接影响的系统需要调试和确认，间接影响和无影响的系统只需要进行调试。
1.4 Indirect Impact System: A system that is not expected to have a direct impact to the “product,”the environmental conditions within critical rooms or chambers, and/or the integrity of the GxP documentation, but typically supports a Direct Impact System. These systems are designed and commissioned following GEP; however qualification is not required.间接影响系统：预计对“产品”不会产生直接影响的系统，对关键房间或操作间的环境条件、或GxP 文件的整体性均无直接影响，但通常是直接影响系统的辅助系统。
这些系统仅需按照GEP要求设计并调试，不要求做确认。
2.0 Initiation of SIAProcess SIA程序的开始2.1 The System Impact Assessment shall identify GMP critical systems. GMP criticalsystems shall require qualification. 系统重要性评估应识别GMP关键系统，且GMP关键系统应要求做确认。
2.2 When a new or existing system has been identified in validation change control or is part ofa project, the System Owner will:当一个新系统或已有的系统已经在验证变更控制中确认，或是某项目的一部分时，系统使用部门需要做：2.3 Determine if there is a SIA existing for the effected system.确定受影响的系统是否已有了系统影响性评估。
2.4 Organize a meeting with required department personnel for conducting the SIA.组织需要部门的人员参加会议以进行 SIA 。
2.5 Prepares the SIA document. Documents results on the SIA form. 准备 SIA 文件，并在 SIA 表格上记录评估结果。
3.0 System Impact Assessment (SIA)系统影响性评估Criteria in the form of questions, along with an understanding of the product, process and nature of the system, shall be used to address the system’s direct impact on product quality in an effort to distinguish a GMP critical system from a GMP non-critical system. 在区分 GMP 关键系统和非关键系统的时候，应用问题形式的标准，以及对产品、工艺和系统本身的了解来取决系统对产品质量的直接影响。
3.1 Direct Impact Assessment直接影响性评估system must be assessed as Direct Impact.如果第二部分中任何一个问题的答案是“是”，系统被评估为直接影响系统。
3.1.3 Enter N/A for the questions in Section 3.在第三部分的问题中填 N/A 。
3.1.4 Document any additional rationale or explanation pertaining to the classification in Section4.关于分类的任何额外依据和解释都记载在第四部分中。
3.1.5 If “No” was identified for all of the questions in Section 2 of the SIA form, thenproceed to the questions in Section 3. 如果 SIA 表格第二部分中所有问题的答案都是“否”，就往下进行第三部分的问题。
3.2 Indirect / No Impact Assessment间接/无影响性评估3.2.1 Answer the 3 questions in Section 3 of the SIA form.回答 SIA 表格第三部分的 3个问题。
3.2.2 If “Yes” was identified for any of the three (3) questions in Section 3, the systemmust be assessed as Indirect Impact.如果第三部分的 3个问题中任何一个回答是“是”，系统被评估为间接影响系统。
3.1.1 Answer the 7 questions in Section 2 of the SIA form.回答 SIA 表格第二部分的 7个问题。
3.1.2 If “Yes” was identified for any of the questions in Section 2 of the SIA form, the3.2.3 If “No” was identified for all of the three (3) questions in Section 3, the system mustbe assessed No Impact. 如果第三部分的3个问题中所有回答都是“否”，系统被评估为无影响系统。
3.2.4 Document any additional rationale or explanation pertaining to the classification inSection 4.关于分类的任何额外依据和解释都记载在第四部分中。
3.3 The documentation shall indicate which GMP impact criteria (if any) a system meets, and its final classification of “direct” or “indirect” shall be noted. The Impact Assessment shall be approved by Validation, Owner and Quality and stored as a controlled document and filed per system number. 文件应标明某系统符合哪些GMP影响标准（如果有的话），并记录系统是“直接”或”间接”影响系统的最终分类。
影响性评估应由验证、质量和使用部门批准，并填上每个系统的编号，作为受控文件保存。
3.4 If the system owner and approval team wishes to assert an assessment other than the conclusion arrived at by the SIA evaluation process, rationale for making such a conclusion must be fully explained and documented on section 4 of the SIA form.如果系统使用部门和审批小组希望维持一个不同于根据SIA评估程序得出的结论的评估，必须在SIA表格的第四部分中充分说明下这样一个结论的原因。