I think in my desire to be brief you have better stated what I intended. As an example of the myriad of "IF's"..some of the largest spammers at the moment use...
My thanks to everyone who replied. This thread is a 'keeper' and here's my take-away: It is possible for a company to use Adobe's digital sigs in a way that ...
Hi all, What is the current cGMP thinking on second checks for critical parameters, if manually collected, is a second check required? I am hearing that the...
Hi, all: Now our company is planning to buy a glovebox, but the glove integrity test method has not been decided. I hope to test the glove integrity on the...
Hi All, I'm wondering what people's opinions are regarding quality audits of software vendors. Is it enough to know that a vendor is ISO certified? I'm...
Hi ffrederson, firstly, verifiy the ISO certificate is authentic. If it is from US, the registrar should be ANAB, if from UK, UKAS. anab.org can confirm in...
Send them some questions that they cannot answer yes or no about. Ask them to provide samples of documentation that you think are critical. Talk to them on the...
The trick is to read what is not on the certificate, as these will only detail the parts of the company that are compliant, but omit any that aren't. I knew a...
Thanks all. Very good information from everyone. Interesting note, I went to the company that did the ISO certification for the software vendor I'm looking...
Hello all, I'm working on my first FileMaker (FM9 + IWP) project and I'd like to know if anyone has any specific suggestions about how to validate the ...
I am trying to understand exactly what the impact of 21 CFR Part 11 on REMS (Risk Evaluation and Mitigation Strategies) is. I have reviewed several REMS...
I imagine that you would evaluate whether the system you are dealing needs to be compliant. If you need to be compliant then you would evaluate what you need...
One is an apple, the other is an orange? One is a set of regulations for compliance, specifically covering electronic records and signatures. The other is a...
I understand what you are saying, however, in the FDA appilcations letters I have reviewed, none of them mention being 21 CFR Part 11 compliant. However, in...
I understand what you are saying, however, in the FDA appilcations letters I have reviewed, none of them mention being 21 CFR Part 11 compliant. However, in...
Unless you are able to provide more specific examples (e.g. what REMS program, which supporting system?) then from the information you have provided I would...
Graham, can it be that the FDA is referring to the Part 11 compliance of a computerized system used to monitor post-marketing REMS and maybe HIPAA for...
Acosta_Harry
Acosta_Harry@...
Jul 8, 2009 1:05 pm
19511
REMS are mostly written using MS Word, so it's difficult to see where Part 11 comes in Siegfried ________________________________ From:...
That is certainly possible. There are quite a few interested parties involved and the primary relationship would seem to be between physician and patient,...
Hi all, I know this is a little off topic, but I am working on a research project on the med device industry's thoughts as to the impact of the impending...
Through the implementation of a PLM system, our documents have a lifecycle that we use to trigger the protections of the object necessary to ensure Part 11...
This conversation comes up in this group fairly frequently and the group is pretty much broken into two camps. Camp A says 'no changes ever to a signed...
I am curious as to why you would firstly get a mistake like "the" being misspelled, and if that was a bad example, what these administrators are really allowed...
As a general industry practice, is it required to use the word "must" for each requirement, or is it sufficient to state that the following requirements must...
Kari E Hulgaard
kari_viking@...
1:49 pm
19518
I don't think the verb IS required, but do accept it is common to use that verb a lot. I understand the verb is used to denote the criticality of the...
... This is based on my experience - YMMV. I've always used "shall" when specifying requirements, and I've always tried to limit requirements documents to the...
I agree with you Mike. It is very important to understand what "Must" go into a requirements document. When it becomes more of a wish list, people lose focus...
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