NEWS DETAILS

Questions about the audit trail 2

日期:2020-09-25 16:07
浏览次数:63
摘要:11. Question: Can the person in charge of the laboratory have administrator authority, for example, to implement audit trail review? Answer: Yes, as long as she/he does not personally perform analysis operations. 12. Question: Can a user have 2 system accounts? One as a user and the other as a manager or auditor? Answer: Yes. It is possible in small organizational units. Through the SOP method to ensure that the administrator account will not be used for op...
11. Question: Can the person in charge of the laboratory have administrator authority, for example, to implement audit trail review?

 

Answer: Yes, as long as she/he does not personally perform analysis operations.

 

12. Question: Can a user have 2 system accounts? One as a user and the other as a manager or auditor?

 

Answer: Yes. It is possible in small organizational units. Through the SOP method to ensure that the administrator account will not be used for operations.

 

13. Question: Do you know which CDS system meets all the requirements of the audit trail function?

 

Answer: As of now, there is almost no system on the market that can perform audits without any effort.

 

14. Question: Files based on data storage: Can be deleted outside of the software. How can we "enhance" security?

 

Answer: For a system that can store data on the hard disk of a local user, two local user configurations can be set. So, for example, you can let the system store data in a place where the user role cannot enter.

 

15. Question: What is metadata?

 

Answer: The data of the data, such as the timestamp.

 

16. Question: What is a production execution system?

 

Answer: Process control system.

 

17. Question: What should the system do? If there is no audit trail, there is no way to perform "user login"?

 

Answer: These systems must be replaced in the short term, or based on the degree of risk, a long-term plan to replace them.

 

18. Question: Equipment usually has a standard audit trail function. It records a lot of data (switches), but only a small part is critical or related to the audit. What are the good ways to deal with the audit?

 

A: A: A better way is to set the parameters of the report so that it only displays the key data and filters out all unnecessary elements (such as login and logout). But this should be reprogrammed, which is very expensive.

 

19. Question: If the production area, such as API production facilities, mixers and filling lines have variable parameters, is there any way to deal with their data/system classification, as well as the degree and time interval of the audit?

 

Answer: The systems and facilities are classified according to ISA95. Then you will find that the bottom layer (field level, PLC, SCADA) does not allow user interaction. Therefore, no audit trail is not required. The foundation is the risk analysis of the system and data.

 

20. Question: Whose job is to perform audit trail review in the laboratory?

 

Answer: It can be a colleague. The FDA requires the "Quality Department" (=QA) to do this in its draft guidance. All other draft guidelines allow peer review.

 

21. Question: Does all electronic data have to be stored and archived when the process of the sterile area and batch records are sufficient?

 

Answer: You should define what is the original data. Except for batch records, these must be stored.

 

22. Question: Do you think the parameter/recipe changes in the production facility are dynamic data? Do I have to consider them in every batch?

 

Answer: These data are managed by change control and are not part of the data to be audited.

 

23. Question: Many of our production processes are recorded on paper batch records. What are we going to do about audit trail review? Do we need to use audit trail review methods to review the good record practices in batch records?

 

Answer: If you are only using paper records, then the audit trail review is irrelevant to you, but the two-person principle applies to all key steps. The FDA guidance mentions the following content "Key process steps must be reviewed by the **."

 

24 Question: Dynamic data VS static data. A small filter facility (pressure measurement/flow measurement/temperature) has an on-site SCADA system. Is this static data?

 

Answer: Yes. If the user cannot modify the data, it is static data.

 

25. Question: Batch records are considered as the carrier for recording the original data of the process. What if the trend data is printed out and attached to the batch record?

 

Answer: I don't think it is necessary to review trend data every time.

 

26. Question: In a laboratory, is it necessary to perform an audit trail review (ATR) after every measurement/analysis performed on the instrument? Who will be the ATP---the laboratory technician (operator) or the person in charge of the laboratory?

 

Answer: Every system needs an SOP to describe the details. The review after the analysis is complete is very important.