kk444555 回复了问题 2023-10-17 22:06

cGMP 数据完整性

问答 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 回复了问题 2023-10-17 22:05

cGMP 数据完整性

问答 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 回复了问题 2023-10-17 22:03

cGMP 数据完整性

问答 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 回复了问题 2023-10-17 22:01

cGMP 数据完整性

问答 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 回复了问题 2023-10-17 22:00

cGMP 数据完整性

问答 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 回复了问题 2023-10-17 21:59

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...

赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 回复了问题 2023-10-17 21:57

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...

赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 回复了问题 2023-10-17 21:56

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...

赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 回复了问题 2023-10-17 21:55

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...

赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 回复了问题 2023-10-17 21:54

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 ...

赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 回复了问题 2023-10-17 21:50

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....

赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 回复了问题 2023-10-17 21:49

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...

赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 回复了问题 2023-10-17 21:49

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...

赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 回复了问题 2023-10-17 21:41

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...

赞同0 反对 0 人感谢 0 评论 1 回复

kk444555 回复了问题 2023-10-17 21:40

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...

赞同0 反对 0 人感谢 0 评论 1 回复