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Integration compliance
Discussions about chromatography data systems, LIMS, controllers, computer issues and related topics.
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Does anyone know where I can find compliance information relating to hplc integration?
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You need to flesh out your question a bit more I'm afraid. DQ/IQ/OQ/PQ or in use or something else?
Where can I buy the kit they use in CSI?
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I am not aware of any specifics. I do know that consistent, automated integration that results in all or nearly all of each peak's area being included are things to strive for.
Any shoulders should be skimmed in a consistent, defensible manner and any manual integrations (avoid if possible) should be marked as such, kept to a minimum and look a lot like the other integrations within a run.
Any shoulders should be skimmed in a consistent, defensible manner and any manual integrations (avoid if possible) should be marked as such, kept to a minimum and look a lot like the other integrations within a run.
Thanks,
DR

DR

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For release I've always integrated everything in the whole run/sequence/sample set with same processing method.
For validations I always did same sample types together when necessary (all 50% linearity together, Sys suit and standards together, etc). Keep in mind that in Galaxie all the integration calculations are based on your largest integrated peak. Do it wouldn't be accurate to use the same processing method for a huge peak as well as that same peak much smaller in a different sample type...unless the method is validated down to that size.
LOD and LOQ I have done manual before as it's subjective anyways and doing it with a ruler and by hand would be even less precise, but is acceptable.
For validations I always did same sample types together when necessary (all 50% linearity together, Sys suit and standards together, etc). Keep in mind that in Galaxie all the integration calculations are based on your largest integrated peak. Do it wouldn't be accurate to use the same processing method for a huge peak as well as that same peak much smaller in a different sample type...unless the method is validated down to that size.
LOD and LOQ I have done manual before as it's subjective anyways and doing it with a ruler and by hand would be even less precise, but is acceptable.
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