Has anyone ever seen the following problem...

Chemstation A.09.01
Agilent HP1100's

A run has been completed and the chromatograms printed out but when the analyst goes back later to reprocess the data the majority of the data subdirectories contain only the run log for the injection.

The run log states "Data not available; Data analysis not done".

There does not appear to be any pattern as to which injections are affected. The problem has occured with two different analysts on two different machines.

Any help/clues gratefully recieved.

Do you just have ChemStation or ChemStore too? If so, the data is most likely in the database and the local copy has been deleted.

Do you have the Security Pack? If so, is the person doing this work logging on as an Administrator of the PC (NOT of ChemStation)? If they are, they will be able to access the directories where the data is held and so could delete it (intentionally or otherwise).

Is this happening on all your ChemStation PCs? If not, it could be you've picked up a virus or something that is deleting the files.

If you have ChemStore and the Study was created WITHOUT removing the check mark from the box which details automatic deletion from the "regular" data directory, make that change and re-save the study. I've also seen where automatic file naming is used (such as 002-0201, which means vial 2, second line of sequence table, first injection on that sequence table line) that someone deletes from the sample table a line (such as an early blank run), then reprocesses, which then causes vial identification mismatches in the reprocessing due to the lines being different in sample data acquisition and in reprocessing. Data directories will normally contain approximately 6 to 8 files, not just the run log file. Also make sure that the data directory specified in the Sequence Parameters when reprocessing is correct.

Thanks for the replies.

As it appens we aren't running Chemstore on these particular machines so it can't be local data directory versus database problem.

Because we've had the same problem on two different machines with two different analysts it makes me think that it can't be an accidental file deletion type of error. The two instances have occurred a couple of months apart which makes me think that its unlikely to be a virus or else we should have had more occurances. The line deletion theory sounds a good possibility so I'm off to probe the analysts.

While we're on the subject of ChemStore though. You guys sound like expert users so perhaps you can clear up something that bugs me about ChemStore. If you don't clear the check box to order automatic deletion then you end up with two copies of the same file - one in the database and one local. How can that be a good thing and how can it comply with CFR 21 Pt 11?

Colin,

You are righ; but there may be some special cases where you need the local data at least for a while (I am thinking about blank substaction for instance).
In this case, you will have to delete the local data by another way (administrator, batch file ...) to keep compliant.

Colin - I also believe that you are correct about the feds want only one copy of the data for 21CFR11; however, that makes stuff really unwieldy for reprocessing, especially if the operators are locked out of being able to read, print, etc. archived data as detailed in 21CFR11, a great catch-22, and would require the administrator to retrieve the archived data (would be required for EACH reprocessing attempt). We have a document in our file for 21CFR11 stating that the Chemstore database directory on the hard drive is the only official archive, let the feds throw me in jail if they can't come up with more reasonable definitions and policies. Colin -just be careful: if you use Explorer, Properties, Security options to prevent regular operators from deleting files, things aren't so straightforward - we've done this on three units, and one works fine (operators can't delete ChemStore files) but on two others we find that if we set up the security the same, then operators can't get into ChemStation, so we had to remove protection. You might find the same if you add security to Hpchem\1\data directory, maybe "ghost" your computer or copy the entire data directory to CD first so you could easily restore if it didn't go right.

Colin, when we were in a hurry and wanted to reevaluate some results, we restarted the sequence in the online session, but did not tick the "reprocessing only". So the system tried to restart a data acquisition (yes, I know, there is the pop up box "Do you want to continue", but as I said, we were in a hurry) and with the pump off, detector on, all files were deleted.

It was a good reason to intensify training!

Just as another thought. To find out who and when these files are being deleted, you could turn auditing on in Windows itself for the HPChem data directory. In NT (don't know about Win2K) right click on the directory, select Security and then Auditing - you will need to be logged on as an administrator for this. Select all files and subdirectories. Click Add to select the users who you want to audit ("Everyone" is your best option) and select what you want to audit, in this case "Delete" for success and failure.

When the issue arises again, you can check the audit trail (in the event log, I believe).