Chemstation sequence tables

[I_Hate_Chemstore]

Is there a way to change the chemstation sequence after the run is complete so that chemstore and chemstation pick up the changes.

I ask because atm we can't seem to alter the table post run. (well we can change it but it isn't picked up)

ie change weights or add them etc

We have chemstore set to save the method and the sequence in the study.

So atm we have to make 100% sure that all data is correct before we start

[Consumer Products Guy]

Sure, you can change weight amounts, multipliers, dilution, method name, etc after the sequence is completed. You set the Sequence Parameters to "Reprocessing only", and make sure to check mark the box just to the left of that (important, or the originally-entered parameters will be used). Then reprocess the Sequence using Sequence Summary Report. The Sequence can be saved if desired as well. We do this every day. That way you can make changes, even to the method, like integration and calibration tables, or to the sequence tables, and save those changes. If you don't do it this way, the settings entered at the time of injection stay, part of the audit and security capability.

[I_Hate_Chemstore]

Thanks for the reply, we haven't had a chance to try this yet unfortunatly, but it was one of the things we had thought about.

one question tho, does this work when the chemstore transfer settings are set to delete raw data?

[Consumer Products Guy]

one question tho, does this work when the chemstore transfer settings are set to delete raw data?

No. If your "Study" is set up that way by the ChemStore administrator, then the data must be restored to the C drive to be re-processed. It must be restored to a subdirectory of the path listed in Sequence Parameters, such as C:\HPChem\1\Data\ or the path will not be correct (that path can be changed using win.ini); usually the administrator has the assigned rights to do ChemStore. The Chemstore file is one file with an mdb extension (I believe), and your raw data needs to be extracted from it back to the C drive for reprocessing.

We do not use the transfer settings to delete raw data, we re-process most times.

[I_Hate_Chemstore]

Thanks, I had a go the other day, and it does work if we restore raw data from chemstore. You can even specify a new path while doing this.

It works, but for some odd reason, sometimes the restore all data section is greyed out. I had to seperate sequences, one i could transfer all data back in one go. The second I had to do each injection seperatly.

If we can solve that issue, then this will work and is easy enough to do.

We have to delete raw data for FDA compliance, or at least thats what our tech guys have said.

We have many other issues still to go tho, so i have no doubt i will be annoying you all with daft posts on these forums

[Consumer Products Guy]

We have to delete raw data for FDA compliance, or at least thats what our tech guys have said.

We only purchased the ChemStore to get into cGMP/FDA compliance, and we do NOT delete the raw data upon transfer to ChemStore. Doing so would require the Administrator to spend a ton of time "restoring" the data for reprocessing. Our SOP clearly states that the Chemstore Database is the official raw data storage location, and any other data is backup. For example, we back up the databases to CD disc when they get to about 650 MB; but the Database on the hard drive is still considered the real data..

[I_Hate_Chemstore]

The administrator doesn't have to restore any data for reprocessing. All users can do that themselves.

We usually try and get the sequence correct first time, then we dont have to reprocess it. Just sometimes we get a number wrong.

For redoing calibration tables and integration events etc, all you do is send back a new batch to chemstation from chemstore with all the injections you want to rework or reprint.

I don't really know if delete raw data is required for FDA or not, this is what our tech support team has told us.

I guess we will find out in a few months when they come and audit us.

[Consumer Products Guy]

OK. I'm R&D, we don't have dedicated instrumentation for our cGMP assays, so we regularly need to adjust slightly our retention times, integration, etc., because we're constantly installing different columns and using different conditions.

FDA has never once ever even asked any at our locations or contract manufacturers during audits if they have electronic data security. The auditors spend most their time looking at documents, records, and SOPs. However, they do have the right to audit anything cGMP-related - so get your ducks all lined up and organized, make sure none of your chemicals are expired, that your solutions and standards are labeled properly, thatyou have C of A documents on file, training records, etc.....