21cfrpart11 at Yahoo! Groups

Re: part 11 applicable for a pipettor system?

Dux, Tom — Thu, 12 Nov 2009 19:26:20 GMT

Per, “would you treat the system differently in the case of only sample prep?” No. The regulations do not discriminate between sample preparation and

Re: part 11 applicable for a pipettor system?

Finner, Doug — Thu, 12 Nov 2009 15:16:04 GMT

I'd look at this as a configurable system. You'd need to do process validation to show that the thing works the way you want (ie calibrate/verify

Re: part 11 applicable for a pipettor system?

paulhurleyuk — Thu, 12 Nov 2009 14:08:14 GMT

... pipettor systems used to prepare samples (this is a computerized system where you automate the dilution of samples, and it's secured with unique user

Re: part 11 applicable for a pipettor system?

Akash Arya — Thu, 12 Nov 2009 14:05:55 GMT

for a chromatography system, that's the system directly associated with a record that'll be required by a predicate rule, so associated records would be

Re: part 11 applicable for a pipettor system?

Dux, Tom — Wed, 11 Nov 2009 21:59:44 GMT

I am not familiar with that discussion, that may be true from a computer programmer's viewpoint of the firmware in the pipettor. However, in this case, it is

Re: part 11 applicable for a pipettor system?

Schmitt, Siegfried — Wed, 11 Nov 2009 21:24:54 GMT

If I remember correctly, we had a discussion in the past, whether a program constitutes a record or not. In my view it isn't as it is not an output / result

Re: part 11 applicable for a pipettor system?

Dux, Tom — Wed, 11 Nov 2009 17:08:17 GMT

I audited a laboratory where they used an automated dilution system for the preparation of solutions used in instrument calibration. They validated their

part 11 applicable for a pipettor system?

akasharya74 — Wed, 11 Nov 2009 14:45:58 GMT

A question about the applicability of part 11 for an automated pipettor systems used to prepare samples (this is a computerized system where you automate the

Re: Designed for Compliance

ricklporter50 — Mon, 09 Nov 2009 14:07:39 GMT

John, This makes sense. Revelation Sofware Concepts (RSC) are an SAP Chnage control software vendor and Rev-Trac, the core technology was recently selected by

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