Be responsible for utility operation, monitoring, PM, and troubleshooting, new utility installation, validation and acceptance, and will be responsible for internal and external audit of utility system.
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The organization shall document validation plans that include methods, acceptance criteria and, as appropriate, statistical techniques with rationale for sample size.
组织应当建立确认计划包括方法、接受标准、如果可以，样本大小的统计技术。(新增)。
FDA a expects the general validation procedures to address who is responsible for performing and approving the validation study, the acceptance criteria, and when revalidation will be required.
FDA要求常规验证程序说明负责执行和批准验证研究的人员，验收标准以及所要求的再验证时间。
Acceptance criteria for accuracy and precision as outlined in section IV. F, "Specific Recommendation for Method Validation, " should be provided for both the intra-day and intra-run experiment.
应同时提供同天和同批试验，在IV.F章节中提到的准确度和精密度的可接受标准。
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