Exporting HPLC data (compliance)

[marina1111]

Hello, I have a compliance question.
We are exporting our HPLC data (Waters with Empower) to excel as a table, and than put it manually (copy/paste) in a validated excel file. Is it GMP? Does the export process should be validated? Something else in this process should be validated? How it can be done?
Thank you very much.

[aceto_81]

I think the copy/paste can't be validated.
I guess you can't do your calculations with custom fields, as this can be made "GMP proof".

One thing you could do is write a VBA script which reads the export file and paste this in the excel file.
That way you skip the manual copy/paste.
Not sure if this is GMP though...

Ace

[krickos]

as "aceto" i am a bit surprised that you do not use custom fields, but to answer your question:
Validated excel files are OK.
The question is, do the reviewer verify,sign and date that the correct data has been transfered to the excel file (ie the copy and paste)?

[marina1111]

Thank you very much for the answers.
The reviewer does sign on the page where the excel print-out attached. The SOP instructs him to check the data entry.
We do plan to move in future to the custom fields.
Problems with it - we are running extended release dissolutions and plotting dissolutions profiles; excel files are visible to other users, results obtained with custom fields are not; we have various types of calculations - so we will have to build multiple custom fields and reports, and to instruct people which fields to fill, in excel it is more straightforward).

[aceto_81]

You are right about the visibility of excel sheets vs custom fields.
On the other hand: you can save your Empower report as a pdf (Electronic signatures or not).

Good luck with the custom fields for dissolution, if you want to correct for loss of volume, it's not that easy to implement in Empower.

You're absolutely right that this is easier in Excel

Ace