I end 21CFR11 based on a risk analysis of what you are doing to the database. If you are performing a standard Oracle function used for regular database...
If you/we are still using a simple username and password approach for authentication then it is bound to fail. As noted keystroke loggers, cameras, PostIt...
Hi Folks Perhaps I have a slightly pessimistic view of server reliability, but one must consider the possibility of introducing a common mode failure point...
Smith_Charles
smith_charles@...
May 1, 2008 3:08 pm
18082
Well Ranjan from the land of Peter Snell....the authentication in Part 11 is based on "a simple username and password approach." In addition, you stated that...
I don't quite understand this comment: "- consider carefully the change control/configuration management aspects carefully. Sometimes one has to restart...
Could we do a new poll? I am wondering how descriptive people get with signatures. For example, one option might just be the roles that the person is...
I think I did not make myself clear. First of all, "Why would a clever admin want to cover his tracks in a document management system?" I leave the "why" to...
Fitz, John
john.fitz@...
May 2, 2008 9:39 pm
18086
Interesting idea - I'll respond. From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On Behalf Of Greg Ventura Sent: Friday, May 02, 2008...
Yes Orlando, the regulation was written in 1997 based on authentication approaches promulgated by the industry years before. Nothing of which has any...
Hi all, A recent WL (Jan 2008) asking Audit Trails.... http://www.fda..gov/cder/warn/2008/320-07-04.pdf "Please note that computerized systems should have...
Enter your vote today! A new poll has been created for the 21cfrpart11 group: A poll has been requested by a member interested in the usage of electronic...
21cfrpart11@yahoogrou...
May 6, 2008 8:01 pm
18090
Hi all, Trying to figure out a way to test for part 11 compliance in a old lab system. It's a coagulation instrument thats controlled by a IBM 486DX computer....
cyfuzhi, Does the equipment actually store the e-records? If it does not, and you print and sign the reports, it may not need to be 21 CFR Part 11 compliant. ...
... you print and sign the reports, it may not need to be 21 CFR Part 11 compliant. ... in a 486 PC system? ... lab ... The system saves the data onto the...
The system saves the data onto the computer and users print out the reports afterwards. The users do not hand sign the printed reports. My understanding of...
For your 486DX system (hey, better than a 486SX right?!) I cannot imagine it being anything other than a Swiss Cheese system and full of holes. Before you...
If the system is using a 486, then I have to ask; how old is the system? If it is pre 1997 then it may not need to comply with Part 11. Suggest reading the...
There is no simple way. There are plenty of testing documents on the market. If you want to do it yourself, then go through Part 11, line by line and list...
Hi Folks! does anybody know if there is an existing auditquestionlist regarding the topics of 21 cfr 820? I would need such a list to include it into a planned...
That is broadly it, as soon as regulatory required data is held in a format that allows editing - your in Part 11 territory. Make certain that it is ...
Answer these questions first: 1) Is the data reqiured by the agency or do you rely on those data to perform regulated activities(e.g. IND package,documents...
Not exactly. Please refer to the Part 11 Guidance issued in 2003. Tom ________________________________ From: 21cfrpart11@yahoogroups.com on behalf of cyfuzhi ...
I too would appreciate such a checklist, but I would want it to be specific. Most of the dialogue here is so "grey" that it is sometimes difficult to pin down...
I am curious as to why you would want a check list? Most bad audits (that I have attended in a variety of roles) used a check list approach and were performed...
Good point. There are many right ways to accomplish Part 11 compliance. Data and/or signature integrity is the requirement. A check list in the wrong hands...
jay.j.chenier@...
May 7, 2008 5:12 pm
18105
For a company (like ourselves) that is just starting to pursue 21 Part 11 compliance a checklist would be a great place to start. We seem to be intimidated...
I understand what you are looking for. Basically you need to come up with your company's interpretation of the regulation. Once you get that laid out...
I'd agree with this. A checklist is a great place to start when you don't know where to begin. It should be tailored to the individual org, though. Another...
Dave Shackleford
dave.shackleford@...
May 7, 2008 5:35 pm
18108
This is a naive question...I don't deal with medical devices and I know part 820 is applicable to medical devices and such. But doesn't the information in...
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