TIA; I have had a similar situation with XRD instruments. A few questions are in order before we can give you advice. You say that access is limited to the...
No you are not compliant to 21§11.10 (c) and (e). Your controls have no effect upon the compliance problem. You could move the data into a more secure...
Dux, Tom
tdux@...
Nov 5, 2008 7:47 pm
18869
It is my understanding that the heart of Part 11 is two-fold; first, build a system that you can believe in and justify, second, fully document the system with...
We had a similar problem - Preservation of records is the heart of part 11. Your software is not compliant, so you must revert to hard copy. AK ... Regards ...
This topic is tangentially related to validation. What are some of the methods used to control the documentation of validated computer systems? At my...
Putting into the contract that deleting a file will result in immediate dismissal usually works better than any SOP. Not the best compliance concept but an...
Hard copy is no protection. The operator can still delete the file before printing anything. The actual record is electronic not paper. A true copy of the...
Dux, Tom
tdux@...
Nov 5, 2008 8:28 pm
18874
Maybe a third-party product such as VelQuest's SmartShell will help you comply. Harry ________________________________ From: 21cfrpart11@yahoogroups.com...
Acosta_Harry
Acosta_Harry@...
Nov 5, 2008 9:05 pm
18875
Did you try running patch IQs? Carl ... [Non-text portions of this message have been removed]...
Thanks for all the advice. I contacted the vendor this morning and it may be that there is an internal breakdown in communication so it looks like a false...
The intention of validation is to verify that the software is installed (not how it is installed). The IQ verification should be a test such as verify the...
Many of our customers have struggled with this. Our suggestion is to reference documentation associated with your computer system within your IQ rather than...
The responsibility rests with the persons who own the regulatory data, no matter where, what or how, part 11 mandates that predicate data cannot be ...
I respectfully disagree with the comment "the intention of validation is to verify that the software is installed (not how it is installed)". The process of...
I fully agree. FDA should pursue implementation of electronic record and signature systems through guidelines or the application of GPEA (Government Paperwork...
Verification in the IQ will also include configuration verification. I dont care if it was not configured correctly the first time and you had to redo it...
Just to pick nits, there's ALWAYS someone who can delete data. Every dba, every system admin--there's always someone with the privilege to delete data. We...
eamo_1976 Sorry to be the security guy ogre here, but... What's the diff? So the software doesn't allow it, but the end user know the work around to achieve...
The last time I spoke to anyone in the know they told me that a new version of 21 CFR Part 11 was "sort of" ready. It was being reviewed at the highest level...
This is true. However somewhere in the validation testing it would be verified that all attempts to dump or adulter data were unsuccessful. I was part of team...
The role of QA has always been a sticky issue from my experience. Traditionally they have been relegated the role of "Cops/Police" which creates a negative or...
You are absolutely right. This is a common problem with instrumentation. Knowledgeable instrument makers won't tell the purchaser it's compliant. From:...
Dux, Tom
tdux@...
Nov 7, 2008 3:43 pm
18889
jimvalidation makes a good point. In my company we are using GAMP5 in conjunction with ASTM2500 as the enablers/drivers to eliminate none value added...
Amen Greg! I always like to say that someone has to have the "keys to the kingdom". You do the best you can to make the system secure, knowing that in the end...
Right--I think the argument in the past was that if an "IT System Admin" had access to the data, they were a disinterested 3rd party that wouldn't have any...
In the (drug) factory of the future there are two employees; a man and a dog. The man's job is to feed the dog. The dog's job is to make sure the man doesn't...
While it might now wait for a new commissioner (by rumor maybe Janet Woodcock), I think there's a lot more to it than that. Again on rumors; the last I...
Greg and Greg, Sorry to be the ogre again, but the "keys to the kingdom" claim is factually incorrect. It is a well understood practice to design and build...
Somehow I got unsubscribed from this group last year and only just now got around to re-subscribing (haven't been involved in anything that triggers 21CFR11...
Having problems with message search?
Fill out this form to ensure your group is one of the first to be migrated to the new message search system.
