Empower 3, calculation, "altered column"

[sssarina]

hi everybody,
i'm new on this forum so please forgive me if i'm wrong.
I am a QC analyst, working in a pharmaceutical gmp laboratory where i use empower 3 software everyday to manage hplc analysis.
When i start with an hplc analys, for example an assay, i have to insert on empower software in the appropriate project ,every sample and standard information needed like N. of vial, injection volume, dilutions, weights, name and number of column ecc. ecc. and if i do a mistake and i have to correct it after the analysis run,in the ,processing and result creation phase, therefore a check in the "altered column" will appear, and always i have to justify it on paper.
The issue is this:
When i have to start another test, specifically a dissolution profile not always the real value for the assay (mg/g) is available, for example because the assay test is running, so even if i have sample weights of the dissolution test i cannot put the real values of "mg of active principle" before start the hplc analysis in empower.
The problem is that in this way i am forced to insert these values after the run, so the chek in the "altered column" will appear.
does anybody know a way to avoid this problem?
in other word ther is a way by which the software take the real value for the assay when that test is completed and use it for the calculation of mg Active Principle in the dissolution test?
and is it possible even if assay and dissolution testa re in different empower project?

Despite my poor english i hope i have explained the "problem" ,
in any case thanks everybody!

Sara

[Blazer]

Hi and welcome to the forum.

If I understand correctly, you're looking for a way to avoid having the altered sample box get checked when you make a change. If you have to manually enter the value after the fact, then the GMP/21 CFR Part 11 nature of the software will always make this box get checked. There isn't a way around it.

The justification that you have to make on paper should be simple enough to satisfy your QA department, however. In fact, if it's a regularly occurring thing, you should be able to draft a memo to file in QA and just always reference the memo (particularly good if your QA department can assign a number to the memo, then you just reference the number). This can be a reasonable workaround so that you don't have to write a long explanation each time.

[sssarina]

So, in your opinion, there is no way to tell to the software to take a value from one test in one project (assay) ad use it for calculations in a test in another project(dissolution), right?
i'm asking because sounds me strange that such software can't do something like this, like you said it is a regularly occurring thing (many times every day) and the reason for the "altered" is obvious..
Thanks =)

[Blazer]

I've got some experience with custom calculations in Empower. I'm not aware of a way to automatically pull a result from Project A and drop it into a calculation in Project B. Hopefully someone more experienced with this aspect of Empower can chime in this thread and help you out.

[shaun78]

Hello Sara,

I do not believe it is possible to accomplish what you are after if the result needs to come in from another project.

This may be possible if the assay result is generated within the same project, but this approach could become very complicated.

Shaun