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打豆豆在 2023-10-17 21:57 发起了提问 cGMP 数据完整性: 问答 How should blank forms be controlled?

kk444555: There must be document controls in place to assure product quality (see §§ 211.100, 211.160(a), 211.186, 212.20(d), and 212.60(g)). For example, bound...; 关注问题 1  0  0 评论

打豆豆在 2023-10-17 21:56 发起了提问 cGMP 数据完整性: 问答 Why is FDA concerned with the use of shared login accounts for computer systems?

kk444555: When login credentials are shared, a unique individual cannot be identified through the login and the system would not conform to the CGMP requirement...; 关注问题 1  0  0 评论

打豆豆在 2023-10-17 21:56 发起了提问 cGMP 数据完整性: 问答 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...; 关注问题 1  0  0 评论

打豆豆在 2023-10-17 21:54 发起了提问 cGMP 数据完整性: 问答 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...; 关注问题 1  0  0 评论

打豆豆在 2023-10-17 21:54 发起了提问 cGMP 数据完整性: 问答 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 ...; 关注问题 1  0  0 评论

打豆豆在 2023-10-17 21:50 发起了提问 cGMP 数据完整性: 问答 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....; 关注问题 1  0  0 评论

打豆豆在 2023-10-17 21:49 发起了提问 cGMP 数据完整性: 问答 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...; 关注问题 1  0  0 评论

打豆豆在 2023-10-17 21:48 发起了提问 cGMP 数据完整性: 问答 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...; 关注问题 1  0  0 评论

打豆豆在 2023-10-17 21:40 发起了提问 cGMP 数据完整性: 问答 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...; 关注问题 1  0  0 评论

打豆豆在 2023-10-17 21:39 发起了提问 cGMP 数据完整性: 问答 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...; 关注问题 1  0  0 评论

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