Have not validated any application that uses Bluetooth for data transfer, but am sure that it is going to be the way in future. It will be interesting to hear...
Dear Aakash, Simple solution for your decomissioning issue, Cut out an OS image of the PC on which the application along with foxpro Db resides and archive the...
Hi Juan, Fully in the spirit of discussion rather than "conversion", let me respond to the question asked and then ask some others: Q: Why would you spent...
Happy New Year to all my colleagues in this forum, may we improve the level of our debate and philosophical approaches and, of course, blessings to all of you...
We (marketing department not me) would like to add some features to our diagnostic device including electronic signature, patient-record tracking, and LIMS...
I work for a small (<20 employee) software development company in Beverly, Massachusetts. We are currently developing an FDA-compliant software solution that...
As far as I know there is no requirement for the a different password for signing versus logging in. Greg Ventura ... From: 21cfrpart11@yahoogroups.com...
Firstly, I would not market it as FDA compliant software. This is a misnomer, you are creating a tool to become FDA compliant. 21CFRPart 11 depends on a...
"I think that we both have our pro's & cons, it is up to the organization to choose the approach. It is the same with testing scripts, there are people that...
wcdude18, 21 CFR 11 does not require a different password for login and signature. However, depending on the design of your system, you may want to use a...
Upon review of my initial response, I did think of one situation that your client may have been referring to. Maybe they were thinking of a system in which...
Hello - My firm did some work for a company like yours, small, and marketing software to companies that were required to comply with part 11. They were...
but it's not a bad idea. adds an extra level of security. ... password ... [mailto:21cfrpart11@yahoogroups.com] ... compliant ... software, ... notes, if ... ...
You don't need to have different passwords for electronic signatures but you need to make an audit trail entery having information about Date and time of...
No No No (my $0.02) People have far too many passwords to remember these days. I agree that passwords should be changed periodically, but to have multiple...
Oh Jeff!!! I do agree with you 100%. I was not referring to 50k Feet high level. I meant to develop a script that proves the purpose but not an overkill of...
Biometric systems are used to controll access to systems. How ever in few systems I had come accross save those data in TEXT file. In those file a person...
For Windows-based devices/systems - SmartShell could be the "remediation" solution. check out www.velquest.com <http://www.velquest.com> Happy New Year! ... ...
Ed Halpin
edh@...
Jan 4, 2007 2:42 pm
16304
A simple solution to this problem may be re ask for password (authorisation) for change of any parameter in the system. Jignesh ... user ... another ... ...
My recommendation is to be sure that whatever you do you be sure you have achieved "non-repudiation." This so that when someone puts his electronic signature...
Perhaps the simplest solution is to use a PKI based token for SSO. This can also be used for signing documents in a 21 CFR part 11 compliant manner. There is...
The more passwords you have the more you appreciate tools like RoboForm We are lucky though to have single sign-on to our systems, just one user ID and...
Schmitt, Siegfried (G...
siegfried.schmitt@...
Jan 5, 2007 6:37 pm
16310
Our company uses network installation program to install programs when needed/requested. These programs can only be used by the person who’s been given...
If there are no electronic records then I am assuming that there is no need for a signature and thus Part 11 does not apply. If Part 11 does not apply then it...
Is RoboForm a program that automatically remembers passwords and populates fields? ________________________________ From: 21cfrpart11@yahoogroups.com...
Another $0.02. I have seen applications that allow the client to specify if they want these two passwords to be the same or not. That way, the software can...
Dear Jigneshbhai, What I comprehend from ur mail is: 1) System has restricted biometric access. 2) Person's identity is stored as code in a .txt file somewhere...