Hello, 1.. File accuracy and integrity can be better verified by using a checksum verifier, such as MD5. There are many checksum generators available, some...
The only part of FDA audits that are confidential are patient identifiers, trade secrets, such as formulas, and - for a reason that eludes me - lot numbers and...
Thanks Greg. My question is how do we verify that the backup was successful. How do we measure that? We back up 100s of files every day, Do I compare the byte...
Hi everyone, if you're validating a system, and there is no specific intended use for certain features at that time, can you validate the system for its...
There are both electronic and paper records; only the paper records are used to meet regulatory record requirements. George did not really answer my question;...
Hi, I agree with Greg, restoring the data from backup is the only true way of knowing the backup is working. Obviously this can't be done everyday but should...
[1] I have not done a backup in a while, but the issue that I have had with byte counts is that there are different factors that can alter the number of bytes...
This is the final Agenda for GAMP Forum in Morristown, NJ March 17th. It includes Discussion and Status Update on Part 11 Rule Amendment (FDA - George Smith -...
Hi I have worked in the Quality department in several different pharmaceutical manufacturing facilities for over 10 years. In every company I have worked for...
It is a good question. We had the same issue in my previous company, We have seperated into two administrators such as functional and technical. The technical...
Hi there, With some of my projects I find it very helpful to assign both criticality and 'need' for each item in the URS. Requirements are either 'critical'...
Margaret, Assume that the data backup was successful. and say the backed up data was 75GB. I perform a data restore once in a month,I would like to know how...
Follow on responses have addressed this. As stated--you validate the backup is working and then monitor it using the tools that are available in the...
I think he answered your question, twice. I don't think it could be said more clear. You just didnt get the answer you wanted. It seems as if you want PLC to...
Hi All After reading some comments on the backup theme, I thoght I would like to add my two cents worth. I have instigated a back up policy for the automation...
Hi Chris, You are indeed fortunate not to have had IT take over management of your Laboratory Systems in your previous companies. I worked in Quality for 17...
My apologies, thank you for alerting me. The correct phone number for registration: Crystal Cowen (ISPE) 813-960-2105 ext.220 Donna Clark (ISPE) at:...
Hi, Your proposal is actually a very good idea; test in advance those features that the client may not need at the moment, but will probably need in the ...
A very good question. I had the same thing try and happen here, and it was one case where 21CFR11 came in handy! There is a provision that states something ...
Thanks Eddie. My question is do you need to restore 100% of files from the backed up data to confim that the restore was successful? or how much % of files do...
Well, my $0.02 is that =I= could have written this very email! However, the one difference has been that so far each time IT has assumed more control of GxP...
I've been watching this thread and thought I'd toss in my $0.02... Ady, Sounds like what you want is someone to offer up THE answer. I have yet to see...
Check out www.3P-Technologies.com who offers a Digital Asset Protection plan for your server and client data. The data is encrypted and stored encrypted and...
I think the more goes on on this topic, the better I understand Ady's question. He is referring to repeated backups. In that case, he should formally...
My group is relocating to a new office building. There are equipments and automated systems that need to be moved. I know that a plan needs to be put in place...
HI Bel manage is product from Belarc it is the IT management system designed for system menagement, it gives reports like Asset tracking wtih detailed software...
raju parikh
rajuparikhus@...
Mar 3, 2006 5:10 pm
15098
I am auditing a system at present against 21 CFR part 11, could you please advise regarding the following points. 1) Is there a minimum limit regarding the...
Let me piggy-back on this thread in a slightly different direction, and ask, how often do you take the back-up tapes off-site? Currently we make daily...
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