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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 2023-08-29 22:44 回答了问题 医疗器械技术评审: 医疗器械分类界定申请资料要求？; kk444555: 医疗器械分类界定申请资料要求 :　　（1）申请材料应真实、完整、清晰、整洁，逐份加盖企业公章，要求签字的须签字。　　（2）申请人填报的表格和编写的申请材料均应为 A4 规格纸张，政府及其他机构出具的文件原件按原尺寸提供。　　（3）凡申请材料应提交复印件的，复印件应清晰，并应在复印件上注明日期，加盖...; 赞同0 反对 0 人感谢 0 评论 1 回复

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