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. 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. 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. The GC/MSD Productivity ChemStation integrates GC/MS data acquisition, data processing, and reporting into one application. 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.
0 kommentar(er)
