... Interesting thought -- In cases where a "non-compliance" was an interpretation and not a clear fact, would the discussions on this list feed into an...
Walden H. Leverich III
WaldenL@...
Feb 3, 2003 2:34 pm
7525
Majella: The general FDA rules such as Part 210, 211, 212, 820, etc ARE the base-line GxP rules that we refer to collectively as the "predicate rules". It's...
Greg: Yes - this is my opinion. It is informed by my years of performing compliance work for FDA-regulated companies in Washington, DC - dealing directly with...
I agree that there is nothing wrong with the scenario you are outlining; no regulation I know of prevents a user from using the same user id and password for...
... I think most users recognize that their userids and passwords are very important, and may even be willing to sign something that says they won't knowingly...
I agree. Also, I think the definition of an electronic signature and handwritten signature under Part 11 need to be looked at closely. Under Part 11, and...
In my opinion Tom you have hit the nail well and truely on the head. Look back to what the predicate rules require. Is there a rule that states you must sign a...
From a legal or logical point of view you are correct, or not, I don't care. What is important is how the FDA interprets signing. The FDA has defined what a...
... Is that the original paper fax as received or the original CRF page at the investigator site that will be discarded? Due to the risk of the CRF containing...
Hi, a pharma co. wants log-in by some specified person to some specified files (raw material cost comparison, for example) to be kept out of bound of trail....
Ashis Dutta
ashis@...
Feb 3, 2003 2:36 pm
7534
The preamble does not say that a logon is a signing. People who misinterpret the preamble say that a logon is a signing. ... that a ... could use ... into a ...
Question on the signature you mention: is this a legally binding signature. If so, what does the "access record" legally bind you to? And does it really ...
Not every record that is being created needs to be signed. The proposed attitude towards "electronic signature" has implications. Keep in consideration that...
If you consider what the value of the computer systems in the datacenter is, and when you consider doing a proper risk analysis on loosing processing ...
The need for two components on signing was given (in my opinion) to _verify_ the identity of a user. I think the FDA wanted to prevent the use of any single...
But then no one in the room watches and records your every move. By logging onto a workstation you accept that everything you do is going to be recorded in the...
proposal is to receive fax into a fax server from remote sites; not so concerned with that aspect as we can size the server to handle a pretty substantial...
The preamble may not, but the guidance documents do, at least in the case of clinical trials. Please tell me where it's at all ambiguous: Guidance for...
Ryan Bolduan
rbolduan@...
Feb 3, 2003 4:56 pm
7542
I think that the FDA would like the industry to be the leader in this area. If we could come to some consensus and have good business reasons for it, then that...
My ATM card doesn't tell me that use of the card is the equivalent of a signature, yet I can get my money out, even if it is not the first thing that I do. I'm...
The audit trail concerns changes to data, not user tracking. I don't think that a person who is only viewing data needs to have their actions put into the...
This list came from the Lab Compliance web site (GLP) 21 CFR Part 58 (GCP) 21 CFR Part 310 New Drugs 21 CFR Part 312 Investigational New Drug Application 21...
fitchw@...
Feb 3, 2003 4:58 pm
7546
I don't know if you have to get down to the error correction capabilities of the fax, but rather be concerned with the resolution and reproduction. A fax does...
Hi, you emailed me earlier. thanks though, Dan ... _________________________________________________________________ STOP MORE SPAM with the new MSN 8 and get...
Dan Carlucci
dancarlucci@...
Feb 3, 2003 4:58 pm
7548
It need not appear in the audit trail, but there do need to be controls for user access and these should include a list of all individuals with access to the...
Paula Wehmeyer
paula@...
Feb 4, 2003 2:36 pm
7549
All, The FDA has announced that they are recalling the guidance on e-Copies. http://www.fda.gov/OHRMS/DOCKETS/98fr/cd02188.pdf It seems pretty straightforward....
Thomas Quinn
tquinn@...
Feb 4, 2003 2:36 pm
7550
Greg, I bet that when you entered in an agreement with the bank you had to sign a contract. Please read this and you know what the responsibilities for the use...
All, I was wondering if anyone has available a requirements document that they are willing to share that was used to help develop a plan for implementing...
Petrarca, Jennifer M
jmpetr@...
Feb 4, 2003 2:37 pm
7552
Although it appears to be quite clear here, it's application is to computerized systems used in clinical trials. All the rest of us have to go by is the reg...
Group, I work for a software company that is looking to developed and provide validation scripts to help assist our clients with their validation efforts with...
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