Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans It is difficult to carry out the separation between the persons of administrator and user in the CDS. Is it possible that the admin and the user being the same person? 1.14K viewsDrugsPharmaceutical 0 Votes 1 Ans Process validation data are category 3 data – therefore no audit trail review is required. But isn’t it required to carry out a review for the generation of validation measuring data? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Why is there a need for this initiative? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans How did the FDA go about this reappraisal? 885 viewsDrugsPharmaceutical 0 Votes 1 Ans What does “risk-based” approach mean? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans Does a “risk-based” approach to CGMPs mean that certain manufacturing processes will not be regulated if only minimal risks are involved? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it an essential element to execute a disaster recovery process on a manufacturing kit during qualification, and do you see any risk with respect to software removal? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans What about systems with no audit trail or an incomplete audit trail? What’s the work-around for such systems? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans Are there examples of audit trail review that are less cumbersome than what Agilent is building into its software? 1.25K viewsDrugsPharmaceutical 0 Votes 1 Ans Can you talk about addressing the challenges of peak integrations in auto mode instead of manual? 1.13K viewsDrugsPharmaceutical 0 Votes 1 Ans Is it ever acceptable to delete data in the eyes of the FDA? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans At some point, there must be an administrator for every system who will have access to modify or delete records, how do you recommend dealing with this potential data integrity problem? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans Is a vendor postal audit enough to satisfy GMP requirements? 1.29K viewsDrugsPharmaceutical 0 Votes 1 Ans When samples are processed, is an audit trail comment enough or is an approval process also necessary? 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans Is x-ray inspection harmful to food or pharmaceutical products? 1.35K viewsDrugsPharmaceutical 0 Votes 1 Ans Is x-ray inspection harmful for those who operate the equipment? 1.06K viewsDrugsPharmaceutical 0 Votes 1 Ans Who regulates and monitors the use of x-ray systems within facilities that use the technology to inspect food and other consumables? 1.47K viewsDrugsPharmaceutical 0 Votes 1 Ans What are some built-in safeguards in today’s x-ray systems used for the inspection of consumable products, including foods? 956 viewsDrugsPharmaceutical 0 Votes 1 Ans What is the “Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century: A Risk-Based Approach”? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans How are companies using innovation and technology to connect with consumers? 1.19K viewsDrugsPharmaceutical « Previous 1 2 … 31 32 33 34 35 … 79 80 Next » Question and answer is powered by anspress.net
