![]() I am no longer in the supervisor position, and the firm may not be willing to spend $. I may send some old emails to you however, I am not sure if you can help. This HP/Agilent MSD Chemstation Software G1701AA for HP 5890 GC and HP 5971 MSD (or HP 5972 MSD) comes with a license. It is an evolution of the Hewlett-Packard ChemStation System. FDA wants to have the "metadata." And don't delete your data files you need to back up data and you need SOP covering that. Agilent ChemStation is a software package to control Agilentliquid chromatography, gas chromatography, and ultraviolet-visible spectroscopy systems such as the 1050, 11 Series HPLC system and the 84 single-beam diode array detector spectrophotometers. In the view of FDA, if you can print various copies of the same chromatogram from Chemstation (or Class-VP, etc), the electronic record (the chromatogram) must comply with Part 11 requirements, even if you delete the electronic data after printing. We have been requested to provide hard copies of audit trails as well. I have represented the lab to repond to FDA auditors when they asked to show the audit trails from the Dionex and Shimadzu LCs. It can not generate audit trails with Chemstation version A, unlike many versions of Chromeleon (Dionex) or Class-VP (Shimadzu). I am really sure that the ChemStation version A is not compliant and I have used it to run the Agilent LCs.
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