Drugs Drugs 1600 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Will new data systems eliminate all need for procedural controls? 1.31K viewsDrugsPharmaceutical 0 Votes 1 Ans When software is updated my, how much revalidation is required? 1.01K viewsDrugsPharmaceutical 0 Votes 1 Ans How do you deal with automatic updates of Windows or antivirus programs? 1.10K viewsDrugsPharmaceutical 0 Votes 1 Ans When a new PC is implemented, is it necessary to revalidate the software? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans Once a vendor is audited, is there a recommended time within which that vendor should be re-audited? 968 viewsDrugsPharmaceutical 0 Votes 1 Ans Regarding GMP lab data integrity: once data are required, can they be modified under any circumstances? 998 viewsDrugsPharmaceutical 0 Votes 1 Ans What should the auditing approach be for software such as the CDS that is no longer supported by the vendor but is still being used within the validated state? 1.08K viewsDrugsPharmaceutical 0 Votes 1 Ans Software sometimes has complicated calculations or algorithms in it, for example, for the integration of chromatograph, is it necessary for the software user to validate the results? 1.06K viewsDrugsPharmaceutical 0 Votes 1 Ans What is regression testing? 1.32K viewsDrugsPharmaceutical 0 Votes 1 Ans How can I ensure and prove that SOPs are followed? 1.01K viewsDrugsPharmaceutical 0 Votes 1 Ans Do pharma companies typically do onsite audits at Agilent to review SOPs, et cetera or are these audits typically paper audits? 1.15K viewsDrugsPharmaceutical 0 Votes 1 Ans Will new data systems eliminate all need for procedural controls? 1.30K viewsDrugsPharmaceutical 0 Votes 1 Ans Some say that [purchasing] the IQ-OQ package [as a complete validation solution] is a myth. 1.11K viewsDrugsPharmaceutical 0 Votes 1 Ans How can MasterControl help pharmaceutical companies comply with CGMP requirements? 1.18K viewsDrugsPharmaceutical 0 Votes 1 Ans What is Q9? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans What is “Guidance For Industry Quality Systems Approach to Pharmaceutical CGMP Regulations”? 1.22K viewsDrugsPharmaceutical 0 Votes 1 Ans Who is covered by this guidance? 810 viewsDrugsPharmaceutical 0 Votes 1 Ans What is the Six-System Inspection Model? 1.23K viewsDrugsPharmaceutical 0 Votes 1 Ans What is the Quality Systems Model? 1.17K viewsDrugsPharmaceutical 0 Votes 1 Ans What’s the connection between this FDA guidance and MasterControl software? 1.31K viewsDrugsPharmaceutical « Previous 1 2 … 32 33 34 35 36 … 79 80 Next » Question and answer is powered by anspress.net
