Hi all, I have some questions regarding, how gap analysis is done. 1) Is Gap analysis done to find out the " gaps" , when we are migrating from a legacy system...
I think there is a lot of value in potentially having a few more SOP's for a retrospective validation where you basically limit the operation of the system...
Graham Tinsley
Graham_Tinsley@...
Feb 3, 2004 1:34 pm
10745
Yes ..That's correct.. management does n't want to spend money in tools like that.! we have started using our spreadsheets for that purpose. Covering old and...
Yes ..That's correct.. management does n't want to spend money in tools like that.! we have started using our spreadsheets for that purpose. Covering old and...
Hello, I hope this is an appropriate forum for this question. I need to validate ( for FDA purposes) a statistical program written in VB that is used to...
Mark Having re-read guidance notes 79 to 81, if it is only about work flow, Scenario: someone takes a sample and it is out side the permitted manufacturing...
Sims, Fraser
fsims@...
Feb 3, 2004 1:37 pm
10749
section 11.50(a)(1) of Part 11 states that signed e reocrds shall contain information associated with the signing that clearly indicates the printed name of...
Sorry Graham I would caution against having additional SOPs What are you going to do differently? You will still need most of the docs to prove validation, RS,...
Sims, Fraser
fsims@...
Feb 4, 2004 5:16 pm
10751
According to 21CFR Part 11 the agency believes that the meaning behind an electronic signature should be shown. Do you belive that it would be sufficient to...
With instruments having more and more capabilities, especially calculations, how do you verify the calculations or don't you. Is the vendors testing enough?...
Gráinne, This is one area where the regulation is pretty clear. Refer to section 11.50, which deals with signature manifestations. Whenever an e-sig is ...
On this issue, it should be clear to the person who is reviewing the document that the signature pertains to a certain and distinct phase of the pharmaceutical...
Rosendale, Don
don.rosendale@...
Feb 4, 2004 5:37 pm
10755
I would think that having it in the audit trail is fine as long as you can run a report on it. Greg Ventura ... From: grainnebarrett...
Ah ha!!! You fell right into my carefully planned trap. Now if I could just remember what it was...... I was not suggesting no validation, just a subtle change...
Graham Tinsley
Graham_Tinsley@...
Feb 4, 2004 8:04 pm
10757
Kathyrn, You make an inspiring (and to those of us who are already True Believers, at any rate) convincing case for the need and value of Validation. But...
Hey All: Speaking of "E-Signatures", can someone please re-explicate its definition? My understanding is that they are electronic versions of the handwritten...
I think you are trying to make a mountain out of a molehill. The issue at hand is not whether validation can be off sourced. It is plain that there is no clear...
Graham Tinsley
Graham_Tinsley@...
Feb 5, 2004 1:40 am
10760
Graham, this is for you: "OOOOhhh, OOOOhhh, EEkkkk, EEkkk". I really don't think at this time validation has a problem with going overseas. I think Software...
Hello...I was wondering if anybody else has this problem:- We often have to do global updates to our IT infrastructure such as security patches to servers....
vanessa.wright@...
Feb 5, 2004 3:06 pm
10763
Morning Group, I have a question on an inventory list containing all computer systems validation information including risk priority, validation document...
Dignah - answer is "not quite," what you are describing are commonly called "digitized signatures" which are a form of electronic signatures, but not the only...
Guida, Richard [JJCUS]
RGuida@...
Feb 5, 2004 3:07 pm
10765
Hi, I am know of a validation company called Seer Pharma.. http://www.pharmasystems.com.au/company/ They are based in Australia but I know they used to have an...
The problem I see with your scenario is that for most COTS systems the system owners are not normally in a very good position to evaluate the risk of an OS...
Unfortunately, for small companies, this might not be a viable solution. It requires a degree of expertise that is probably not available, as well as ...
K. I did not see a reply to this yet so here are my thoughts: A "gap analysis" is not a specific document. It is just a general term that can be applied to...
John DeFazio
John_DeFazio@...
Feb 6, 2004 2:03 pm
10770
... <Kaszerd@w...> wrote: Does anyone know of a good guidance for COTs systems in the pharmaceutical industry. My particular concern is for lab instruments. ...
I'm in a discussion regarding Audit trail records. I believe that the audit trail should contain who performed a given task or made a change. The argument...
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