Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Hello, is is useful to review the “windows eventviewer” for GxP devices? 1.42K 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? 1.31K 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. 1.44K viewsDrugsPharmaceutical 0 Votes 1 Ans May the Head of Laboratory have admin rights for example to carry out the audit trail review? 1.56K 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? 1.42K viewsDrugsPharmaceutical 0 Votes 1 Ans Do you know a system that fulfils all requirements for the audit trail function of a CDS? 964 viewsDrugsPharmaceutical 0 Votes 1 Ans File based data retention: Deletion is possible outside the software. How is it possible to “build in” safety? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans What are metadata? 1.20K 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? 1.47K 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? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans Whose job is it to carry out the audit trial review in the laboratory? 1.73K 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? 1.35K 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? 1.01K viewsDrugsPharmaceutical 0 Votes 1 Ans Are the analytical data arising in the course of the validation of analytical procedures critical data? 1.36K viewsDrugsPharmaceutical 0 Votes 1 Ans The calibration of equipment influences the correctness of data. Does this mean that the calibration is critical? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans What about a reactor control from production that has neither user management nor a password or an audit trail etc.? Is it allowed to continue using this control? 1.39K viewsDrugsPharmaceutical 0 Votes 1 Ans What about a reactor control from production that has neither user management nor a password or an audit trail etc.? (The control concerned is the control of a reactor which is used for the manufacture of intermediates and APIs but not of final products). Is it allowed to continue using this control or does it have to be withdrawn from use? 1.21K viewsDrugsPharmaceutical 0 Votes 1 Ans Is the audit trail review prior to the release of each batch a regulatory requirement or is it only recommended so far? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans Hybrid systems: No audit trail retrofitting possible. What can be done? 1.10K viewsDrugsPharmaceutical 0 Votes 1 Ans Role concept: Is a user allowed to carry out a reintegration? (GC-system) 1.28K viewsDrugsPharmaceutical « Previous 1 2 … 30 31 32 33 34 … 79 80 Next » Question and answer is powered by anspress.net
