Brent I think you are quite right to be concerned. If you change a record, then the signer can repudiate it which is sure going against the point of the...
Sims, Fraser
fsims@...
Aug 1, 2007 1:34 pm
17030
The key point for me is always that the electronic version must not be worse than the paper one. Once the equivalent paper document is signed, will you be able...
Hello, the most important is to be able to trace all changes. My recommendation would be to use a change management and to have an indentifier in our eCRF...
FORGET the reg. FORGET what the vendor is telling you (and by the way, vendors can't sell P11 compliant systems; they can only sell systems that faciliate ...
This is one of those "all roads lead to Rome" things -- the question is not so much HOW you are able to identify your CRF change history, bu IF you are able to...
Hi all! we are considering implementing the electronic signature functinality to review and approve SAS codes. However the solutions we saw do not meet...
In my opinion, your vendor is disregarding reasonable and obvious conclusions of 21CRF11.50 and 21CRF11.70. The text of these sections and the agency...
The question is not are signatures required by Part 11, but what regulation requires a signature for SAS code. I assume that you mean a SAS program for...
I don't see any conflict, but maybe I am mis-reading your post. In your workflow, signatures are only valid for a given record at a given point in time. There...
Only records required under predicate rules are subject to 21 CFR Part 11. Not all regulated processes generate required records, and this includes signatures....
Hi! those signatures are used to "review" and "approve" SAS programs. I think there is no regulation for this, however the Part 11 Scope and Application says -...
To have it said, there are solutions for SAS that completely meet Part 11 expectations in terms of e-signatures. The may not be an option due to cost,...
I have adopted the following guidelines: For electronic signatures to be subject to Part 11 they must meet one or more of the following criteria: *A signature...
Minus the consideration of whether e-sigs are required or not ClearCase makes an elegant technical solution for SAS in pharmaceutical companies because of its...
Paul There can't be such a checklist, although some people put together a series of questions in order to check for GxP activities. The basic question is...
part 1: use of authority checks to ensure that only authorized individuals can use the system This sentence element requires the system/manager to ensure that...
Although I agree with Siegfried the questions may have to go beyond impact on product: e.g. are activities such as handling traceability for recall purpose, ...
hi all, i'm pondering how to approach this type of situation (sorry for being wordy, but this actually happened): i'm sure everyone tests this type of...
Your testing is done. You have an SDLC, you followed it, you completed it. Issues found in production are just that and need no formal linkage to your prior...
Where I work, I wouldn't be permitted to go back and fail something after the val summary report was signed and we were in a production environment... Knowing...
Your latter solution would be the correct on in my opinion. Check the requirements or scope defined in your CAPA process. If justification for opening a CAPA...
The requirement that items, usually in a warehouse, go out through the out door in the same order in which they came in through the in door First In First Out-...
First in / First out (FIFO) is used in inventory control to ensure old inventory is used up before new inventory (someone isn't just placing new received stock...
The system still meets your requirements. It goes beyond your requirements. it does not create a less secure situation so it is very low risk. I would just...
In computer programming, FIFO (first-in, first-out) is an approach to handling program work requests from queues or stacks so that the oldest request is...
Reading the history of the standard it looks like FDA initiated the request for this standard. FDA being USA's organisation, is this standard followed only in...
The purpose of locking the user account after 3 failed login attempts is to prevent an unauthorised person from making a large number of successive login...
What happens if user "A" logs in 2 times incorrectly, then user "B" logs in 1 time incorrectly (and user "B" is now locked out), then user "A" logs in...
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