Re: 21 CFR part 11 compliancy

From: Till Maurer <till.maurer_at_gmx.de>
Date: Fri, 9 Nov 2001 09:19:00 +0100 (MET)

> Hello out there,
> We are in the process of tackling the problem of how to achieve 21 CFR
> part
> 11 compliancy for our NMR Lab. My impression of standard NMR software
> (Bruker/Varian) is that they have at present big holes in this respect (no
> disrespect intended). I am therefore very interested in contacting any of
> you who have tackled or are tackling this problem to share ideas and
> experience or even just to gauge how many see this as a requirement for
> their systems.
> David Grace
> Oslo
>
Dear David,

I have just returned from the Bruker Users Meeting in Germany and
there the aspects you mentioned were adressed in form of an audit
trail and electronic signatures. The XWINNMR release3.1 should
comply at least to some to the 21 CFR Part 11 regulations.

If you are an XWINNMR user, it may be worth looking to the Bruker
home page or contacting Mike Engelhardt at

nmr-software-support_at_bruker.de

Cheers

Till Maurer

-- 
*****************************************************
Boehringer Ingelheim Pharma KG
Department of Chemical Research
88397 Biberach, Germany
phone: +049-7351-54-5883
fax: +049-7351-83-5883
e-mail: till.maurer_at_bc.boehringer-ingelheim.com
*****************************************************
GMX - Die Kommunikationsplattform im Internet.
http://www.gmx.net

Hello out there,
We are in the process of tackling the problem of how to achieve 21 CFR part 11 compliancy for our NMR Lab. My impression of standard NMR software (Bruker/Varian) is that they have at present big holes in this respect (no disrespect intended). I am therefore very interested in contacting any of you who have tackled or are tackling this problem to share ideas and experience or even just to gauge how many see this as a requirement for their systems.

David Grace
Oslo

Received on Fri Nov 09 2001 - 09:50:33 MST