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@...
Jul 16, 2009 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...
One other comment - if you use Traceability as a disciplined approach, then for compliance purposes: All requirements MUST trace to a regulation (internal or...
A requirement for a requirement: interesting. I prefer using the word "Shall"; it conveys formal commitment and more flexibility than "Must". ... From: Kari...
Tulio Luna
gmpauto@...
Jul 16, 2009 5:06 pm
19523
My concern is that if all requirements are written with "must," it creates a high criticality for everything, which is redundant with the fact that it is a...
Kari E Hulgaard
kari_viking@...
Jul 16, 2009 5:07 pm
19524
Hi Kari The regulators have stated that in the URS requirements must be clearly given, and not be ambiguous in any way. Clearly in any URS there will be...
I take unambiguous to mean stay from a requirement such as: The system shall/must (whatever word you want) be user friendly. There is no specific requirement...
Agreed. However, if all of the requirements must be met, can the author of the URS not compose a statement that all requirements must be met, unless...
Kari E Hulgaard
kari_viking@...
Jul 16, 2009 5:27 pm
19527
If it is in a requirements document, it should be important. Isn't one using a risk based approach if the requirements procedure is stating to only include...
I agree with you. It is just a matter of style and some preferring to keep with their way of doing things since that is how it has been done in the past. I...
Adding to what Mike said...If you're figuring out what's important in your system, then that's the preliminary stages of system selection or project scope. At...
Graham, I can't answer for the poster, but for us, we would not make a big deal about 'teh'. In our case, we'd unsign/recalculate documents because there was a...
I'm curious to see what folks think about what triggers the validation of a computer system? I have heard a numebr of times over the years "We'll get this up...
Well - if on the first day, God created light, I am reasonably certain that the day before he wrote a validation plan. So the sequence would be.. Create the...
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