Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Is it acceptable to only save the final results from reprocessed laboratory chromatography? 981 viewsDrugsPharmaceutical 0 Votes 1 Ans Can an internal tip regarding a quality issue, such as potential data falsification, be handled informally outside of the documented CGMP quality system? 1.01K viewsDrugsPharmaceutical 0 Votes 1 Ans Should personnel be trained in detecting data integrity issues as part of a routine CGMP training program? 965 viewsDrugsPharmaceutical 0 Votes 1 Ans Is the FDA investigator allowed to look at my electronic records? 1.28K viewsDrugsPharmaceutical 0 Votes 1 Ans How does FDA recommend data integrity problems identified during inspections, in warning letters, or in other regulatory actions be addressed? 908 viewsDrugsPharmaceutical 0 Votes 1 Ans What is the Processes of Complying with Pharmaceutical Compliance? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the Significant Aspects of Pharmaceutical Compliance? 966 viewsDrugsPharmaceutical 0 Votes 1 Ans Many of our production processes are documented by means of a batch record on paper. What should we do as concerns the review of the audit trail? Should we review the good documentation practice in the batch record by means of an audit trail review? 998 viewsDrugsPharmaceutical 0 Votes 1 Ans A small filtration facility (pressure measurement/flow measurement/temperature) with a locally installed SCADA system would then rather deliver static data? 1.12K viewsDrugsPharmaceutical 0 Votes 1 Ans What is an “audit trail”? 1.05K viewsDrugsPharmaceutical 0 Votes 1 Ans How does FDA use the terms “static” and “dynamic” as they relate to record formats? 1.07K viewsDrugsPharmaceutical 0 Votes 1 Ans How does FDA use the term “backup” in § 211.68(b)? 2.00K viewsDrugsPharmaceutical 0 Votes 1 Ans What are the “systems” in “computer or related systems” in § 211.68? 2.07K viewsDrugsPharmaceutical 0 Votes 1 Ans When is it permissible to exclude CGMP data from decision making? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans Does each workflow on our computer system need to be validated? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans How should we access to CGMP computer systems be restricted? 950 viewsDrugsPharmaceutical 0 Votes 1 Ans Why is FDA concerned with the use of shared login accounts for computer 198 systems? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans How should blank forms be controlled? 1.26K viewsDrugsPharmaceutical 0 Votes 1 Ans How often should audit trails be reviewed? 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans Who should review audit trails? 1.29K viewsDrugsPharmaceutical « Previous 1 2 … 29 30 31 32 33 … 79 80 Next » Question and answer is powered by anspress.net
