Thanks, it looks like we will try moving to PNG. The file size reduction and it being loss-less is a benefit, but we also need to be able to review the results...
Hi everybody! A couple of people were asking me about a new draft of 21CFRPart11. Does anyone know, if there is a draft and if it's already available? Thanks...
To answer you first query, all activities during the validation excercise need to be documneted to demonstrate what had actually happened during the exercise...
Hi Sandip, I think for point #1, there would be two cases. See if this makes sense: Case #1 The executor has made a mistake during the execution of the OQ and...
Are we not taking it too far with respect to 21 CFR part 11. the case is simple here, since there is no storage involved of any spreadsheet and the printed...
Girish .I agree with your case 1 & 2 In OQ script I'm maintaining the Deviation form were I mention deviation and its resolution ...and there will be such type...
Hi all, Can anybody recommend an auditor (preferably x-fda) that specializes or has good experience in auditing GXP computerized systems? We work with good...
If you mail me direct (siegfried.schmitt@...) I can give you some names Siegfried ... From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com]...
Schmitt, Siegfried (G...
siegfried.schmitt@...
Nov 2, 2006 3:10 pm
16109
Does the spreadsheet calculate anything? Is is anything that is required by GxP? If yes, then you are using the electronic record for GxP purpose.... and then...
Hi, No, the point is not if anything is calculated, the point is what you rely on for your regulated activities. The following is lifted from the "Scope and...
Hello, We are implementing a workflow tracking system and our designated system admin also has duties in some of the workflows. The vendor has suggested giving...
I've used this approach before in a clinical trials system. I was the only Data Manager account in this system, which allowed me to edit data, etc. I ...
Hi, There is indeed a risk. But by using two acccounts one cant race who has done what , when using the particular account/accompanying rights. So it is...
Philippe Mussche
pmussche@...
Nov 6, 2006 4:24 pm
16114
Hi Kurt: That is a good recommendation, providing that the admin account is identified with the user id and not as ADMIN. If that's the case, create an admin...
If the vendor provides Role based security model then you can put these users in two different roles and also into workflow definations. All above description...
Yes ... but part 11 and validation are not synonymous. A spreadsheets need for validation should be assessed first and the assessed for applicability for part...
Andrew Gibson
agibson@...
Nov 8, 2006 5:31 pm
16117
Hi Andrew, Exactly my point - Every system used to make critical calculations or transactions in a regulated industry requires som level of validation - but a...
My apologies if this has already been discussed on the list. I only recently located the link to the Forum and have not had a chance to read the backlog of...
General Rule: If it is quality data/information, if it relies on electronic signatures, and may/will go in front of an auditor, then it needs part 11...
Can anyone recommend consultants that have direct experience validating ERP, specifically Oracle EnterpriseOne? Thanks. MODERATOR NOTE: VENDORS RESPOND...
Forgive my ignorance, but I thought the rule was (as modified by guidance) that if the data is explicitly required by a predicate rule, then part 11 applies. ...
Which FDA reg(s) affect your hospital? This/these will be the predicate rules that drive your behavior. The reason I ask is that I'm not sure the FDA...
This is the argument I have heard from many sources:.. Is my data required by GMP? How do I get that data? If it is GENERATED by the electronic spreadsheet...
I've been hearing that the FDA is beginning to focus more on ERP systems such as SAP. In particular they will be looking at alignment with Predicate Rule....
All, within the company I'm based, there is a mix of R&D and Diagnostics. In the context of validation this means that within the R&D department, there is no...
Steve please contact me at siegfried.schmitt@... Siegfried _____ From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On Behalf Of...
Schmitt, Siegfried (G...
siegfried.schmitt@...
Nov 15, 2006 4:14 pm
16128
Hello Everyone, Have any of you had any experiences with the FDA (or other regulatory agency) taking a look at how SAP (or another ERP System) has been ...
Hello Steve I do recommend a company called Bioteknica (US based with an subsidory in Europe)have been working with them several years. They are very...
Atoosa Bayat
atoosa.bayat@...
Nov 15, 2006 4:19 pm
16130
Hey All, ... There seems to be a discussion along these sort of lines every month or so. Each application is different enough that there is enough variation. ...
Could it be that the hospital is performing clinical trials? Greg Ventura ... From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On Behalf...
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