Hi, I am looking for some advice - When does a report that supports a FDA filing need to be Part 11 compliant? I would assume if the electronic report were...
Hi you sound as if you are using quantitative LC-MS (Analyst, Masslynx or Excalibur) linked to Watson LIMS for bioanalysis and/or pharmacokinetics. On this...
Bob McDowall
r_d_mcdowall@...
Apr 3, 2006 1:35 pm
15260
--> Paul, my replies below Paul Hurley <http://www.paulhurley.co.uk/> http://www.paulhurley.co.uk <http://www.paulhurley.co.uk> ... with the name. ... ID and...
Greg, In our case, all users are in one big bucket - IT handles everybody no matter what site they're at, or their function. We cannot have duplicate names...
Greg, I agree that trust is critical but I also think there are valuable reasons to have a validation witness. The first one that comes to mind is mistakes,...
Hi Jim, I do not think that reports must be Part 11 compliant. The e-signature embedded to the e-report and the e-records required by the predicate rule that...
Usually, doing something because "everyone else does it this way" or "it's the accepted industry standard way of doing it" is trite and superficial but not in...
I would have to disagree with "two people can keep each others mind active and sharp." The times I have spent watching someone else do work, just to make sure...
Hello Group, I need input from the group in structuring the IT SOPs which are being used worldwide at our different site locations. In the current scenario we...
Guess that's what makes this world great--different ways to handle the same requirements. I wouldn't do it your way, you wouldn't handle it mine. That's fine...
hi everyone, if you had a situation where a system was validated and released (lab is now generating data on the system)... if later you determine there were...
Dear all, I have read several correspondences and found that some consider PLC program as e-record and some donot.I wish to know the exact stand of FDA on this...
Like with many things, you have to go case-by-case, but you always have to do a risk analysis. What is the risk of letting them continue working while you do...
I think this is one of those questions that will always stimulate debate as each of the methods has both its postives and negatives. Disabled: Pro - If you...
Hi, I would think you should make sure your following any operating procedures you have that govern this type of situation. Second, update your validation...
I'm planning to promote a company policy for e-sigs that provides for a double standard with password privacy. Sales staff often require password assistance...
I do not believe that code in itself can be an electronic record. After all it does not contain information pertaining to product quality. Unless a record is...
Schmitt, Siegfried (G...
siegfried.schmitt@...
Apr 4, 2006 8:49 pm
15276
Soham et al, When it comes to PLC's there are definitely mixed feelings, and perhaps it has to do with what you consider a record. My viewpoint is record is...
My recommendation would be to keep the SOPs very high level to include a procedure which details what needs to be accomplished with required deliverables and...
Kari Habeck
kari_viking@...
Apr 5, 2006 1:37 pm
15278
You are confusing part 11 with software design and validation. They are different and often go hand in hand in projects. CFR 820 is the medical device...
Andrew Gibson
agibson@...
Apr 5, 2006 1:37 pm
15279
Hi all, 1) Any software, including PLC Ladder Logic, should not be considered a GxP electronic records with regard to Part 11. The software engineering ...
We are trying to eliminate SOP binders in most departments (finally). If the signed SOP's are scanned into Adobe files and watermarked as "Working Copies" for...
In an analytical lab here are three scenerios: 1. An analytical instrument is stand alone with paper print out results. [since this instrument is paper based...
Greg, And that's a VERY important point. Too often there seems to be a rush to define 'THE ANSWER' when we're talking about regulatory items. There are...
We only maintain one printed binder of SOPs and that is for auditors from our clients. All of our SOPs are maintained on our intranet. They are signed...
... Since SOPs are specifically required by the predicate rules, Part 11 would apply to the scanned SOPs. They would essentially be an electronic record with...
Vicky, There are many document management software (dms) applications available in the market place, so their comment of electronic SOP's being in violation of...
Dawn Staniewicz
dawns@...
Apr 5, 2006 4:33 pm
15287
1. I'm assuming you have no way to manipulate the printout. For example an old IR or a balance. 2. Why store the data and have paper printout? Depends. If...
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