In our case the metaphorical options might be more properly: I live in a used rental trailer with holes in the roof and my most expensive possession is a...
The Requirement is that the testing be performed, to demonstrate compliance with the requirements It doesn't much matter what the protocols are called, if all...
Dave, Your last paragraph touches on what, in my opinion, may be the most important document of all validation documents: The Traceability Matrix With a...
And for more great geek humor, try http://xkcd.com and http://indexed.blogspot.com Who says geek can't have fun? If I could get 1/2 the obtuse crap out of my...
Hello, Did you specified any performance related specifications in URS of Data Entry software ?. If yes then your PQ should contain following documents 1) The...
Mike, Agree 100% with everything you say, except for a small point in the first paragraph; it's difficult to create a good traceability matrix unless you have...
Dave, Yes, that's true. The URS is extremely important, and depending on the level of user community you're working with, this can be the most difficult...
A quick question. Do the regulations or guidance state a requirement for having a minimum of two levels of access authorization (i.e. user name and passwords)?...
D, May be someone can help find the word I'm looking for. Co... Bilateral Authentication should happen at the same time. The word I'm looking for starts with a...
Mike In response to your comment, "If you have tested all related functions, what's left in a PQ?", I believe there is a definite place and use for a PQ....
Mike, Yes and No. I've been combining the FRS and the DS into a CS (Config Spec) for Cat. 3 / 4 systems. The configuration primarily consists of the security...
Can you all help set me straight with a couple of questions I'm not real clear on? 1. What are the predicate rules? I believe they are anything that is in the...
I am investigating using Vermont HighTest to automate at least part of our validation testing. We tried using another product but auditors have been uneasy...
Brent, I think you're on track regarding the predicate rules. Here's a segment from an internal document I wrote that surveys the Part 11 literature: Although...
... Wrong question. When do YOU _WANT_ an audit trail? When does it make sense for you and your business to track changes to electronic records? When does it...
I've been enjoying the interest groups on MeetUp.com and I notices some groups target professionals in the BioTech/pharma industry. Would anyone like to have...
like other comments earlier, don't get hung up on the 'names.' i think the confusion lies in what you're intending to do, not fitting tests into boxes without...
David, We went through the same process. Recently, we have identified and implemented a validation automation system; it manages all phases of the validation...
Thanks Doug, although I think I should clarify my position a bit. I come from being a QC manager of a vaccine manufacturer (pretty clear where the regulations...
Hi, Can I ask how you went around signing individual test cases and their attachments? Once the automated script is run and all the forms are produced one need...
Mikhail Mineyev
mikhail.mineyev@...
Apr 11, 2007 1:37 pm
16606
Validation Slave What validation automation system did you use? Regards Deirdre Deirdre Matthews Matthews Consulting IiBC, GMIT Dublin Road, Galway. Ph:...
Hi Validation_slave, Could you give more information about your validation automaton system. Is this package commercial available ? Kind regards, Philippe ...
Philippe Mussche
pmussche@...
Apr 11, 2007 4:05 pm
16608
Hello, It's been over a year now since a federal judge denied FDA's request for an injunction against Utah Medical Products. The decision seemed to contradict...
All, I have been in this group for several years and have posted very few times, only when I felt that I could offer some thought-provoking commentary. I have...
From the American Heritage Dictionary: contemporaneous adj. Originating, existing, or happening during the same period of time: the contemporaneous reigns of...
I would appreciate if someone who is using MetricStream's Document Management Module to share their experiences. Regards Senthil MODERATOR NOTE: COMMERCIAL...
Close Nat and thank you Tom. Contemporaneous Bilateral Authentication Therefore, based on this guidance, we have two levels of access authorization, username...
... IQ/OQ/PQ were never "required" as the basis for validation; they were simply a convenient form that allows companies to conduct validation in a manner that...
Hey all, I'm wondering how others in the industry are documenting their training activities, specifically for SOP training (after revisions and for annual...
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