Data Systems and 21 CFR Part 11

[Sallybeetle]

We are looking to purchase a new data acquisition package (software, computers, etc). From all of the posts on this board, I see that many have struggled with the same issues with which we are currently wrestling.

My question has to do with Data Acquisition Systems and 21 CFR Part 11. Currently, we are using the HPLC / GC data system to collect, reprocess, and print chromatograms / peak areas only. We do not have online system suitability (SS) or calculation (b.t.w., manually drawing resolution and tailing factors sucks. Sorry if this isn't appropriate for this website). The company stance is that the hard copy is the original data.

With the new software, I want to do online calc's and SS to provide better consistency and time savings. However, some in my community believe that this would invoke 21 CFR Part 11; and, I agree with this stance. However, they think that making SOPs and a policy statement for data acquisition to be 21 CFR Part 11 compliant will force a policy statement on the entire company, i.e. no legacy systems allowed in the entire company because of one system in the lab.

Sorry for the 'wordiness;' but, is this correct?

[Alfred88]

Dear Sallybeetle:

For data acquisition software, I strongly recommend to consider Chromeleon package by Dionex. This package has 2 parts: server to control many instruments, and client to interact with server. This software can do system suit calculation, resolution, tailing etc. (online) as you want. Its built-in spreadsheet is similar to Excel. What I like most in this package? The control panel can be customized as you wish: buttons, charts, temp control, etc. can all be added or removed, or moved around. It is very easy to customize compared to VB6 or even Labview. And don’t ever think about C++ with DriverLink-it’s a pain to debug. (I had played with these as a graduate student).
You can get Chromeleon up and running in a few hours. Also, this package is compatible with several hardware brands. One caution note: salespeople may not know how to use the software or troubleshooting it, even though they may give you a demo on their notebook pc. And don’t count on the trainer (after the software is purchased) to set up the software for you. You need to develop internal capability.

As for 21 CFR Part 11 compliant, each software vendor will provide a certificate of compliance for you. If you don’t use electronic records and electronic signatures, the new requirements are not applicable to you. However, you need to have control on: access security (password logon), audit trail capability (who did what), and backup. And you still can use legacy systems (because the new requirements are not for them).

Disclaimer: I don’t work for Dionex, and will not get any benefit from them.

Alfred.

[Alex Buske]

Just a slight correction:

A Software (i.e. a CDS) cannot be 21cfr part11 compliant. the way you use it must be compliant. So a vendor certificate won't help very much, it just assures the the software has build in some features that help to use it in a compliant way.

Alex

[Chris]

I would have to agree with Alfred that Chromeleon is extreemly poweful and what has impressed me most is the system suitability function. Working in a contract lab we get all sorts of wierd and wonderful client specified criteria and Chromeleon has coped with them all.

Only grumble is that you have a minimum and maximum criteria you have to put it in as two lines (i.e. one for upper and one for lower). The results from the system suitability checks can easily be included in a summary report. Also if you are into control charts these can also be added to your report.

By switching from a mix of manual data transfer to LIMS and manual system suitability checks to Chromeleon we easily save 0.5 to 1 hour per person per day. Put the time imto setting the system up properly and it will pay off rapidly.

[DR]

I think that 21CFR part 11 compliance is an expensive option with Chromeleon (and some other packages). I have not personally used it (yet), but someone in my lab did manage to overwrite a data set by rerunning a sample set - I'm thinking we either did not purchase the 21CFR option, or it was hobbled on installation...

As far as doing tailing factors etc. - there are other ways to get there.

Check the February, 1992 LC-GC. Glen Ouchi has a column in which he covers some alternatives to rulers. Given that you have a (presumably) more modern data system, you can take the same approaches but more easily. If your current data system displays the time and mV of wherever you put your mouse on a chromatogram display screen, you're more than half way to getting USP tailing calculated...

(http://www.lcgcmag.com/ only goes back to 10/2000 )

[unmgvar]

Like Alex Buske said a software is sold with the possibility to be setup to be compliant to GLP and CFR 21 part 11. it is the customer's final responsability to make it compliant, and validate the installation.
and according to the narrow interpretation of the clause, you must be compliant if you do not intend to have paper format at all of your records or decide that the electroninc format of is the final reported format and the one that is archived.
if you do not do this then you would need only to be cGLP compliant.

DR if you do have the GLP version of Chromeleon i can help you set it up to your GLP needs if you want to do so.