Agilent approach of using ACE for Qualification

blr1981 over 5 years ago

When Agilent does qualification of any Agilent HPLC/GC/GCMS using Agilent software, Agilent use ACE technology for generating results. From the data integrity point of view in pharmaceutical industry, this is not right as the result has no linkage with raw data. Also we can never identify whether all acquired data has been processed or not?. Can we get some clarification on this approach of Agilent.

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jhagel over 5 years ago +2

Hi Lakshmi, Here is the reply from our compliance group.... Traceability and Audit Trails Data are generated by the same native chromatography data system (CDS) used in the daily operation of the instrument…

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0 abdur over 5 years ago

Hi blr1981,

This attached brochure might be useful to you.
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0 blr1981 over 5 years ago in reply to abdur

Hi,

My question was on the unattended data lying the source chromatographic application. They are not processed or signed off in the chromatographic application. This is a serious data integrity issue

Thanks and Regards
Lakshmi Rathan
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0 blr1981 over 5 years ago in reply to blr1981

To bring more clarity in my discussion,

1) A set of 6 injection was acquired in openlab cds for repeatability/precision test as a part of qualification.
2) The data is now transferred into ACE for further processing
3) The results are generated in ACE and reported from ACE
What happens to the raw data generated in Openlab? who will process the data? In most of the pharmaceutical companies, the unprocessed data needs justification.
So want to know
why Agilent is not processing in openlab and keep the results available in openlab?
ACE should be choice of customer and shall be decided during the procurement process

Thanks and Regards
Lakshmi Rathan
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0 blr1981 over 5 years ago in reply to blr1981

To bring more clarity in my discussion,

1) A set of 6 injection was acquired in openlab cds for repeatability/precision test as a part of qualification.
2) The data is now transferred into ACE for further processing
3) The results are generated in ACE and reported from ACE
What happens to the raw data generated in Openlab? who will process the data? In most of the pharmaceutical companies, the unprocessed data needs justification.
So want to know
why Agilent is not processing in openlab and keep the results available in openlab?
ACE should be choice of customer and shall be decided during the procurement process

Thanks and Regards
Lakshmi Rathan
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