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kk444555 在 2023-10-17 22:06 回答了问题 cGMP 数据完整性: Can I use electronic signature instead of handwritten signature?; kk444555: Yes, electronic signatures with the appropriate controls can be used instead of handwritten signatures or initials in any CGMP required record. Althou...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:05 回答了问题 cGMP 数据完整性: Is it acceptable to save paper printed records instead of original electronic records?; kk444555: A paper printout or static record may satisfy retention requirements if it is the original record or a true copy of the original record (see §§ 211.68...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:03 回答了问题 cGMP 数据完整性: Can electronic copies be used as accurate reproductions of paper or electronic records?; kk444555: Yes. Electronic copies can be used as true copies of paper or electronic records, provided the copies preserve the content and meaning of the original...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:01 回答了问题 cGMP 数据完整性: How often should audit trails be reviewed?; kk444555: If the review frequency for the data is specified in CGMP regulations, adhere to that frequency for the audit trail review. For example, § 211.188(b) ...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 22:00 回答了问题 cGMP 数据完整性: Who should review audit trails?; kk444555: Audit trail review is similar to assessing cross-outs on paper when reviewing data. Personnel responsible for record review under CGMP should review t...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 21:59 回答了问题 cGMP 数据完整性: 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...; 赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 在 2023-10-17 21:57 回答了问题 cGMP 数据完整性: 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...; 赞同0 反对 0 人感谢 0 评论 1 回复

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

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