21 CFR Part 11

Chromatography Forum: LC Archives: 21 CFR Part 11
Top of pagePrevious messageNext messageBottom of pageLink to this message  By Jack on Thursday, June 28, 2001 - 05:12 am:

I understand the electronic records part of 21 CFR, but does anybody know if there are any regulations concerning where processing of data must occur with a server based system with multi instruments? Can the processing occur on a local computer to the instrument or must it occur on the "locked down" server? 21 CFR Part 11 indicates that all electronic files must reside on the secure server but what about the processing?


Top of pagePrevious messageNext messageBottom of pageLink to this message  By Anonymous on Thursday, June 28, 2001 - 05:30 am:

I beleive that your processing could happen anywhere. BUT.... the second raw data is processed it becomes a result or a report which are electronic records (assuming a computer did the processing) and have to follow the 21CFR11 rules. So, if you create results on a non-compliant system, and then transferd them to the secure server, I would belive that you would be in violation of the regulations.

Any other opinions out there?


Top of pagePrevious messageNext messageBottom of pageLink to this message  By Anonymous on Thursday, June 28, 2001 - 02:00 pm:

I agree, I think basically all systems used to obtain and process any analytical data must be done on a 21 CFR part 11 compliant system. I don't think you need to process the data on the same computer that your instrument is hooked up to, but which ever computer you select must be compliant. I don't think the computer you select to process the raw data needs to be connected in any way to the computer used to generate the raw data (i.e. you can save the raw data to a durable storage device, then transfer it to a secure stand alone computer and generate your results from there).


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