21cfrpart11 at Yahoo! Groups

Re: XLS File for Winonlin

pktastic — Sat, 07 Nov 2009 21:40:20 GMT

Hi Keshav, I don't know if you got the file you needed. I can't add attachments but if you have WinNonlin you can find the file you need as clayton.pwo in the

Re: SaaS - LIMS/ analytical software

pktastic — Sat, 07 Nov 2009 21:39:39 GMT

sorry to resurrect an old thread, I'm new to the forum and did a search to look for people's experiences of hosted database for clinical trial data. My

Re: Audit Trail - why changes were made

Cinzia — Wed, 04 Nov 2009 13:55:52 GMT

here all ref to audit trail - see 4.9.3 when they cite "and explained" - that is the reason for change. ICH E6 4.9.3 Any change or correction to a CRF

Re: Infor Enterprise Asset Management v8.x

Tom Mizukami — Mon, 02 Nov 2009 19:02:55 GMT

Thanks Siegfried - that's the path we are on. On Mon, Nov 2, 2009 at 8:02 AM, Schmitt, Siegfried < ... [Non-text portions of this message have been removed]

Re: Infor Enterprise Asset Management v8.x

Schmitt, Siegfried — Mon, 02 Nov 2009 16:24:36 GMT

Hi Tom My take on this is to validate and not to use e-sigs. In any case, you probably only have very few signatures that are required by the predicate rules

Re: Unidentified and Archaic Technology Media

Greg Ventura — Mon, 02 Nov 2009 15:16:17 GMT

Can you actually say it is not GXP data, maybe it is just poorly maintained? I would say that the cost of: - Trying to see if you can read the data. - Trying

Re: Unidentified and Archaic Technology Media

mfsprague — Mon, 02 Nov 2009 14:55:57 GMT

Thanks for the reply. The hypothosis here, is that the archaic media has, for example, suddenly appeared out of the server basment from long ago, and even from

Re: Infor Enterprise Asset Management v8.x

Tom Mizukami — Fri, 30 Oct 2009 17:54:17 GMT

It contains calibration records, parts inventory, maintenance procedures, etc for pharmaceutical manufacturing equipment. On Fri, Oct 30, 2009 at 7:49 AM,

Re: Unidentified and Archaic Technology Media

Martin G. Knop — Fri, 30 Oct 2009 15:35:11 GMT

I agree with Greg here - except that I would replace "little crazy" with "sheer lunacy". It seems the data retention policy and implementation of it are

Re: Infor Enterprise Asset Management v8.x

Schmitt, Siegfried — Fri, 30 Oct 2009 15:13:00 GMT

Hi Tom I wonder why you would have to validate it. Does the system have an impact on product quality? Regards Siegfried ________________________________ From:

Re: Unidentified and Archaic Technology Media

Schmitt, Siegfried — Fri, 30 Oct 2009 15:09:49 GMT

I suggest you get a copy of the ISPE guide on electronic data archiving - should answer all your questions Regards Siegfried PS given the track record of our

Re: Unidentified and Archaic Technology Media

Greg Ventura — Fri, 30 Oct 2009 14:33:54 GMT

I am not a Federal Auditor, but I would wonder why you are keeping media that you cannot read? What is the purpose? Did you ever upgrade the backups to new

Re: 483 Citation for Learning Mgt System

STANLEY110@... — Fri, 30 Oct 2009 14:22:17 GMT

Very well said. Stan Alekman In a message dated 10/30/2009 9:07:31 A.M. Eastern Daylight Time, brad.cooper@... writes: There is way too much

Time sync

val_anon — Fri, 30 Oct 2009 13:10:55 GMT

Hello Everyone, I was just wondering how everyone is handling time 'sync-ing', in particular I am wondering about how much "leeway" (if any) do you allow

Infor Enterprise Asset Management v8.x

tom_mizukami — Fri, 30 Oct 2009 13:07:59 GMT

Hi, I was wondering if anyone has validated this platform. We have deployed it on Oracle and it has a good audit trail. The electronic signature however, is