By smfields on Wednesday, April 25, 2001 - 03:15 pm:
Our compliance group maintains the FDA is going to want to see that all interim integration results are stored and retrievable. That is to say, as the analyst would normally tweek or optimize the integration params, they have to store every batch cycle. With 100s of files that get time/date stamped to differentiate (Turbochrom), this is an impending nightmare. Does anyone agree with that initial assessment? Alternative strategies?
By chris knutsen on Thursday, April 26, 2001 - 01:35 am:
That is my understanding also. You probably need a method to archive all of those files. This may include zip files, etc. I do know that there is a software company called Nugenesis that has worked with PE turbochrom to develop archiving software. I think that they are at nugenesis.com
good luck
chris
By Anonymous on Friday, April 27, 2001 - 06:44 pm:
You might want to try a diferent data system. We are using Elite EZChrom (was a previous TC user)and it stores all of the interim results and methods within the data file, so unlike TC you only endup with 1 file, which contains everything.
By Anonymous on Thursday, May 10, 2001 - 12:45 pm:
This, in my opinion, is proof positive that the FDA is stuffed to the gills with morons who have no clue. What possible value could there be in such interim results? Sheesh....
By Anonymous on Saturday, May 12, 2001 - 07:34 pm:
As far as the FDA is concerned, everybody is cheating. So they want a complete record of your attempts to cheat... Just be happy that the IRS has not yet mandated similar traceability for your tax preparation software...
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