Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans When is it permissible to exclude CGMP data from decision making? 1.68K viewsDrugsPharmaceutical 0 Votes 1 Ans Does each workflow on our computer system need to be validated? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans How should we access to CGMP computer systems be restricted? 1.16K viewsDrugsPharmaceutical 0 Votes 1 Ans Why is FDA concerned with the use of shared login accounts for computer 198 systems? 1.61K viewsDrugsPharmaceutical 0 Votes 1 Ans How should blank forms be controlled? 1.46K viewsDrugsPharmaceutical 0 Votes 1 Ans How often should audit trails be reviewed? 1.34K viewsDrugsPharmaceutical 0 Votes 1 Ans Who should review audit trails? 1.63K viewsDrugsPharmaceutical 0 Votes 1 Ans Hello, is is useful to review the “windows eventviewer” for GxP devices? 1.43K viewsDrugsPharmaceutical 0 Votes 1 Ans Must the report for a riew of the audit trail be generated by the system itself? Or is it possible to use another system which is better suited for carrying out analyses? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans I think, I did not express myself very clearly when asking the question: Is it only reviewed whether the process is still functioning in the course of the periodic reviews – hence, if the audit trail data is still recorded? Meaning: Functionality is documented by IT with a few samples. 1.45K viewsDrugsPharmaceutical 0 Votes 1 Ans May the Head of Laboratory have admin rights for example to carry out the audit trail review? 1.57K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it possible for a user to have two system accounts? One as a user and one as administrator or reviewer? 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you know a system that fulfils all requirements for the audit trail function of a CDS? 979 viewsDrugsPharmaceutical 0 Votes 1 Ans File based data retention: Deletion is possible outside the software. How is it possible to “build in” safety? 1.20K viewsDrugsPharmaceutical 0 Votes 1 Ans What are metadata? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans Equipment often has a standard audit trail function. A lot of data is recorded (on/off), but only a small part of it is critical or relevant for a review. What is the best way to proceed when carrying out a review? 1.51K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the way to proceed in the case of facilities in the production area such as AP production, mixers, filling lines with variable parameters as concerns classification of data/systems, extent and intervals of review? 1.33K viewsDrugsPharmaceutical 0 Votes 1 Ans Whose job is it to carry out the audit trial review in the laboratory? 1.77K viewsDrugsPharmaceutical 0 Votes 1 Ans Must all electronic data be stored and archived in the case of a process in the sterile area or is the batch record sufficient? 1.36K viewsDrugsPharmaceutical 0 Votes 1 Ans Would you consider changes of the parameters / formulations at production facilities as dynamic data? Do I have to consider them at every batch? 1.02K viewsDrugsPharmaceutical « Previous 1 2 … 120 121 122 123 124 … 283 284 Next » Question and answer is powered by anspress.net
