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kk444555 在 2023-10-17 21:56 回答了问题 cGMP 数据完整性: How should access to CGMP computer systems be restricted?; kk444555: You must exercise appropriate controls to assure that changes to computerized MPCRs or other CGMP records or input of laboratory data into computerize...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 21:55 回答了问题 cGMP 数据完整性: Does each CGMP workflow on a computer system need to be validated?; kk444555: Yes, a CGMP workflow, such as creation of an electronic master production and control record (MPCR), is an intended use of a computer system to be che...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 21:54 回答了问题 cGMP 数据完整性: Determining CGMP data as invalid is not considered as a judgment of batch conformity?; kk444555: Data created as part of a CGMP record must be evaluated by the quality unit as part of release criteria (see §§ 211.22 and 212.70) and maintained for ...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 21:50 回答了问题 cGMP 数据完整性: What are the “systems” in “computer or related systems” in § 211.68?; kk444555: The American National Standards Institute (ANSI) defines systems as people, machines, and methods organized to accomplish a set of specific functions....; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 21:49 回答了问题 cGMP 数据完整性: How does FDA use the term “backup” in § 211.68(b)?; kk444555: FDA uses the term backup in § 211.68(b) to refer to a true copy of the original record that is maintained securely throughout the record retention per...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 21:49 回答了问题 cGMP 数据完整性: How does FDA use the terms “static” and “dynamic” as they relate to record formats?; kk444555: For the purposes of this guidance, static is used to indicate a fixed-data record such as a paper record or an electronic image, and dynamic means tha...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 21:41 回答了问题 cGMP 数据完整性: What is an “audit trail”?; kk444555: For purposes of this guidance, audit trail means a secure, computer-generated, time-stamped electronic record that allows for reconstruction of the co...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 21:40 回答了问题 cGMP 数据完整性: What is “metadata”?; kk444555: Metadata is the contextual information required to understand data. A data value is by itself meaningless without additional information about the dat...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 21:39 回答了问题 cGMP 数据完整性: What is “data integrity”?; kk444555: For the purposes of this guidance, data integrity refers to the completeness, consistency, and accuracy of data. Complete, consistent, and accurate da...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-09-14 16:54 发表了文章: 文章拓扑图与架构图

1、拓补图拓补图：拓扑结构图是指由网络节点设备和通信介质构成的网络结构图。在选择拓扑结构时，主要考虑的因素有：安装的相对难易程度、重新配置的难易程度、维护的相对难易程度、通信介质发生故障时，受到影响...; 赞同0  697 浏览  0 评论 kk444555 2023-09-14 16:54

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