We get fliers for low mortgage rates sent to our fax machine all the time. I would imagine that a system that allows this would be considered open. I wonder is...
we're working with a LIMS application right now, and the vendor has a tool which allows the client to 'configure' the application thru a gui. by 'configure,'...
Hello Everyone, I am new to computer system validation. Can anyone tell me,when the validation risk assesment is carried out? Is before developing VMP or after...
Hello! In § 11.1 (b) it says: "However, this part does not apply to paper records that are, or have been, transmitted by electronic means." Does this help? ...
I love philosophy. To borrow from a phrase used in golf Compliance is best achieved while in a state of grace. Or more bluntly, you're only as compliant as...
As everyone is doing validation as they are subscribed to this forum. Background: We manufacturing products that are to be implanted in humans, e.g. spine...
I work for a medical device company and we manage our software requirements with a requirements management tool (RequisitePro) and tracks defects with a change...
G'Day, ... Usually one of the several approaches described. ... 1st Assumption) The CNC machine is a commercial off the shelf machine and nothing has been...
Wherever there is more than one record, it is essential to establish which one is relied on when decisions are made, which may impact on the patient. These may...
Raj To assess if your system requires validation, I suggest you carry out the risk assessment before you write the VMP. It will save you time and effort. ...
The vendor has provided you with a tool to accomplish the task. As such, the vendor bears the responsibility for quality of the tool. Much the same way that...
Regardless of whether it is GAMP category 4 or 5, I think the amount of time you spend validating should be proportionate to the amount of time you spend...
thanks bob, i wasn't questioning the tool itself, i'm questiong if what you're creating with the tool is considered 'customized.' because the vendor tool is...
Hi, not sure I really understand your senario but iin the medical device company where i used to work we used to approve some items in a register at defined ...
To question the result is to question the source. If the tool performs configuration, it may create fields, tables or even databases, but will never create...
Hello Raj, There are many factors that may come into play in this case depending on the intended use of the system and regulatory considerations. There is the...
The validation of an HPLC system cannot be fit into a single outline. The hardware consists of a pump, injector, column, detector and data system. The pump,...
Dux, Tom
tdux@...
Dec 5, 2007 2:40 pm
17329
Raj; I think you need to be more specific. "HPLC System" can denote a wide range of choices and configurations. You may have just as well asked, "Can anyone...
Hi Any LIMS solution by default should be a validated system and comes with standard functionality and on top of that you add the flavors that you need to work...
Sarang I have a question what does validation cover that IQ, OQ and PQ does not? Greg Ventura (P.S. Everyone else should feel free to join in on this as well,...
Sarang, I am quite surprised. I expect that a LIMS has functionalities that allow it to be Part 11 compliant. Design validation may (should!) have occurred...
A search of the Forum doesn't reveal any recent discussion on this topic; has FDA had anything definitive to say (if that phrase is not oxymoronic) about the...
Greg, Probably you got me wrong. Let me explain, LIMS generally belongs to the GAMP4 category of configurable software packages. However, parts of LIMS systems...
Just an FYI From Federal Register: December 4, 2007 (Volume 72, Number 232) Food and Drug Administration 21 CFR Parts 210 and 211 [Docket No. 2007N-0280] ...
Hi Mort, Just my 2 cents 1. Prepare procedure on how those tools are used and controlled (i.e., SOP for ReqPro, Quality Center, ClearQuest, the business ...
In case anyone interested, at my site I'm introducing the MOTS abbreviation for Modified Off The Shelf type of system. (COTS Commercial Off The Shelf). The...
uh oh, looks like the original question is taking an alternative path. let me try to reign the discussion back into my original question, which i'm thinking...
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