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Dear All,
Kindly comment on the followings:
One of the analyte is validation on waters system and during the subject samples analysis due to instrument failure, the study is divided into two systems i.e. Waters and API.
Half of the subject of the study is analyzed on waters systems and half of the subjects are analyzed on API system. however the change of the instrument is supported by onely one P&A batch.
My understanding is to perofm atlest three P&A, matrix effect and selectivity/ sensitivity on other (API) instrument to justify the conduction of study.
Kindy suggest the correct practice and give if there is any reference on the above mentioned case.
Regards,
Auditor.
Kindly comment on the followings:
One of the analyte is validation on waters system and during the subject samples analysis due to instrument failure, the study is divided into two systems i.e. Waters and API.
Half of the subject of the study is analyzed on waters systems and half of the subjects are analyzed on API system. however the change of the instrument is supported by onely one P&A batch.
My understanding is to perofm atlest three P&A, matrix effect and selectivity/ sensitivity on other (API) instrument to justify the conduction of study.
Kindy suggest the correct practice and give if there is any reference on the above mentioned case.
Regards,
Auditor.
Complete thread:
- Different make of instrumentauditor 2011-06-29 08:21
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Different make of instrument Ohlbe 2011-06-29 10:06
Ing. Helmut Schütz