What should I include in my Chemstation revalidation?

Chromatography Forum: LC Archives: What should I include in my Chemstation revalidation?
Top of pagePrevious messageNext messageBottom of pageLink to this message  By Anonymous on Thursday, July 1, 1999 - 08:18 pm:

I have recently taken over the pleasant chore of running three HP 1100 series LC's. One is a bianary, and two are isocratic. I now have to revalidate the software system because I just received the 6.03 version of Chemstation. I have never written a validation before. I really need some suggestions on what to include in my validation report and some test cases to run. Does anyone have any suggestions? Thanks in advance for the advice.


Top of pagePrevious messageNext messageBottom of pageLink to this message  By Sue on Friday, July 2, 1999 - 02:14 am:

You did`nt state whether you want a full validation or operational qualification.You could include a checklist of all the steps from correct initialization of the instrument modules, to confirmation that the security features work to confirmation that the instrument functions control pump flow,lambda changes etc.
ChemStation contains an internal verification test
which can form the bulk of your validation:
In Data Analysis, click on View/Verification/RunTest.
select the verification file (hpchem\1\verify).
Check Integration,Quantification, and Print Analytical Report in the Run Test box.Check Print Test Results to : Printer and Print Task Protocol and OK.
Do this for each *.val test listed and this should cover everything you need.


Top of pagePrevious messageNext messageBottom of pageLink to this message  By Luke on Monday, July 5, 1999 - 08:59 am:

Hello

I believe that HP offer an ChemStation Operational Qualification product.
You pay them and one of their engineers will come and run a documented qualification procedure for you.

Luke


Top of pagePrevious messageNext messageBottom of pageLink to this message  By SRS on Tuesday, July 6, 1999 - 02:46 am:

You can also buy the OQ from them and do it yourself. They will send you all the documentation and info needed to perform it yourself. It might take yo longer to do yourself, but it saves on the cost of the labor/travel.


Posting is currently disabled in this topic. Contact your discussion moderator for more information.