The issue of 100% testing for software is that most software these days is so complex that it is simply impossible to do 100% testing. Therefore the regulators...
Sorry to be a bother here. My (new) question is this: Given: A computerized data acquisition system that generates electronic records but does not have the...
It seems to me that you have several misconceptions. A computer system can be fully compliant without having electronic signatures and / or audit trails. Also...
Hello, I'd be interested in your thoughts & ideas on a long winded question. We think the answer to this question is yes but we want to explore all ...
Saludos, My replay are in red and based on the US FDA Scope and Application Guidance (2002??). Cheers, Orlando López CSV Senior Advisor & Validation...
for file comparing you can also use http://www.grigsoft.com/ (compare it). It say that it support mac text files but since I don't used mac I never tried it. ...
Norm, A) How do you define "100% fit test" on a patient? B) How do you extrapolate from one patient that the process will work for every patient? C) How...
What Class of medical device is this? How many fit tests fail? Graham _____ From: 21cfrpart11@yahoogroups.com [mailto:21cfrpart11@yahoogroups.com] On Behalf Of...
A. A trained, certified orthotist checks the fit on every patient. from Wikipedia: An orthotist is a person who measures, designs, fabricates, fits, or...
This is good example of where the risk analysis is helpful. Prepare a good risk assessment, and then justify what you decide is necessary in the way of...
If the electronic system is used to generate a paper record which is then signed and that paper record is used for all GMP purposes then the use of the...
short answer – YES Validation of the manufacturing process, including any electronic systems is a requirement of 21 CFR 820.70(i) Also if the fit is wrong...
'IF Electronic signatures are required, then that electronic signature must comply with the requirements of 11.100, 11.200, 11.300: as a first step you should...
I have to disagree on your first paragraph Dave. The system must still comply with 21CFR Part11 in that it does create electronic records. E-sigs is only a...
Actually I think you're wrong...the final guidance on Part 11 (see Guidance for Industry, part 11 electronic records; electronic signatures - scope and...
Then, according to your analysis you can have e-sig on papers. Great! Orlando Lopez Sent via BlackBerry by AT&T ... From: "akasharya74" <akasharya@...> ...
... E-sigs ... I agree with that one. There are many aspects of Part 11 that are only related to electronic records and not, necessarily, on signatures. The...
... Does it matter that: 1) the paper record is a printout of electronically-recorded data that has been manually composed or compiled by the user, 2) the...
Here's something that's not clear to me. If an electronic data recording system is used to generate electronic records, then theoretically a user could...
Hello all, I´m currently trying to establish all funcionalities that a LIMS proyect need to have. The idea is developed in-company. After that, I am going to...
I know we have been branching out in our discussions into areas related to 21 CFR Part 11, but I don't think that helping you write a LIMS URS is part of that....
Hola Carlos, I have experience with LIMS for many years (over 20). In my experience, LIMS created in house costs a lot more money than a vendor solution and...
Some questions back to you which might help put this in perspective - and I won't mention regulations.. Did you make a decision involving the Device using the...
Do we get paid for providing you a list of these functionalities? Perhaps even copyright or royalties on your LIMS system? I know I am excited to see this...
I just pointed to the guidance, but I totally agree it doesn't really make sense why someone wouldn't rely on the electronic record just to avoid Part 11 (like...
It's funny you ask this. Even before Part 11, inspectors constantly requested to bring up the electronic data file for a printed chromatogram from a CDS....
Hi, Can somebody help me out in finding an economical, user friendly, CDM software? My purpose is not big but to do small Clinical trials (like phase I...
Martin, Based on the information given in the original question; it appears that the electronic system is being used to generate a paper record which is then...
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