FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans My question relates to the electronic signatures (CFR Part 11): When electronic data were approved by using an electronic signature and a problem with the approved data was found, am I allowed to fix it and reapprove (with electronic signature) the change. 1.51K viewsFDA 0 Votes 1 Ans Should an Excel spreadsheet be validated that is used for trending of stability data? 1.66K viewsFDA 0 Votes 1 Ans Auditing Systems for 21 CFR Part 11-Validation of Software Programs – We have a GcP app on a server. When we need to install some additional utility apps and supporting app on that server such as Adobe Reader, Word and Firefox, do we need to qualify or validate these software programs? 1.47K viewsFDA 0 Votes 1 Ans In process validation, how important is VMP? 1.59K viewsFDA 0 Votes 1 Ans what is root cause analysis 1.80K viewsFDA 0 Votes 1 Ans Auditing Systems for 21 CFR Part 11 – Validation – How do we keep our validations from becoming “War and Peace”? 1.39K viewsFDA 0 Votes 1 Ans What is the format of the product list in CECATS? 1.46K viewsFDA 0 Votes 1 Ans Is there a limit to the number of attachment pages? What happens if my request is over 25 pages? CECATS 1.48K viewsFDA 0 Votes 1 Ans Does it matter which establishment is identified as the Primary Facility? CECATS 1.63K viewsFDA 0 Votes 1 Ans CECATS is asking me for a prepaid return shipping label. What does that mean? 1.43K viewsFDA 0 Votes 1 Ans How long will it take for FDA to process my request for a certificate? CECATS 1.57K viewsFDA 0 Votes 1 Ans How can I check on the status of my application? CECATS 1.59K viewsFDA 0 Votes 1 Ans What do I do in response to a Return for Action notification? CECATS 1.38K viewsFDA 0 Votes 1 Ans Why can’t changes be made to an application that is marked “Incomplete”? CECATS 1.68K viewsFDA 0 Votes 1 Ans Is there a CECATS fee to receive an export certificate? 1.68K viewsFDA 0 Votes 1 Ans Can I get additional certificates from CECATS? 1.28K viewsFDA 0 Votes 1 Ans How do I use a VFD feed? Veterinary Feed Directive 1.48K viewsFDA 0 Votes 1 Ans What is “extralabel use” of a VFD drug and is it allowed? Veterinary Feed Directive 1.49K viewsFDA 0 Votes 1 Ans What are the Client’s Responsibilities on VFD?Veterinary Feed Directive 1.61K viewsFDA 0 Votes 1 Ans What are FDA export certificates? 1.59K viewsFDA « Previous 1 2 3 4 5 6 7 … 75 76 Next » Question and answer is powered by anspress.net
