Hello group ! The IT guy is involved in the SAS software validation, just because he has the admin login rights and did no other contribution. The SAS...
We use electronic signatures for all of our validation documents. The burdens for testing were no different than the normal testing for any other system using...
Hello all. I have a question in regards to documentation of the IQ. Where would be the best place to list the requirements for a software's installation? I...
Hello. I am in the process of creating a template for software validation risk assessment. I am planning to create one risk assessment template, which will...
Himanshu You define who the owner is. This is not defined by the way the system is used. Here the IT person merely understands the technical issues, whereas...
I think this can be answered simply enough. Can the administrator really administer software that they do not understand? I think the administrator needs to...
One thing to keep in mind is how you intend to use the URS. Does that strictly cover the User Requirements designed to help select the system, or does it cover...
Thank you Matt, it does help. The specification document I have written for this software does contain all of the software functions, as the company already...
Thank you, I am familiar with this and many other documentation on risk assessment, but unfortunately I don't think it really answers my questions. Most texts...
I believe in keeping it simple, basically you need to assess whether the system needs qualified. this is pretty easy - is it GXP..... Another aspect to look...
There is a risk that in using a weighting or number based system you will end up with boundary cases which create exceptions. Some people then move to an ever...
Himanshu, Be very careful about performing all of the software testing while logged in as an administrator. Frequently, permissions-based errors are not...
Hi all, i have some doubts about the FS and DS, i donīt understand very well if a Functional Specification defines what the system should do or will do. On...
Sounds like you are doing fairly well already. Remember that risk assessment is pretty much an empirical tool and that no two people will have exactly the same...
I wish I had a black and white answer for this one since it's something I constantly struggle with but as Graham says it's '..a journey...'. I tend to keep the...
UML, in my opinion, is a beautiful fit for the DS. We are bringing activity diagrams, class diagrams, sequence diagrams and state diagrams into our DS...
Don't forget about internal policies and procedures as well. Of course, this is already covered because GxP requires you to follow your own SOP's so I guess it...
I vote for wither the DDS or a separate technical document. The installation requirements are not known until you have designed and built the system that meets...
Hi Stephane, mi recommendation is the next: The Risk Assessment must be realizated respect at the grade of impact with the quality product afectation, for...
Hello Thanks all ! I believe, the admin right of the IT guy, being limited to addition / deletion of software, may be predefined in the validation protocol. ...
Mitchel Well, that is a brave statement. If the printer doesn't print my certificate of analysis or batch record correctly, the batch could be erroneously...
You may be assigning this a "high risk" but what's the probability? That's another aspect of risk analysis. Otherwise we could sit around forever coming up...
I think were other posts on the forum related to this, try some key word searches. I hear your pain though, I've worked at a lot of places that run thru the...
Hi everyone, The FDA's latest guidance on the scope of Part 11 was saying that if you rely on a paper record of the e-record, that Part 11 wouldn't apply... ...
Greg You misunderstood me, I was only referring to the fact that printers were ruled out as having a direct impact. I've seen plenty of times that something...
I think that using paper printouts of electronic records is mostly lazy and the thought process behind this kind of activity is partly responsible for ...
OK--but if something doesn't print (or someone walks away with a printout--a common occurrence too and unvalidateable) are you still able to release the ...
Totally agreed on the merits of electronic vs paper. The question was hinting more at the policy shift in a way. When Part 11 came out, the original raw data...
Ask the ex owners of Able Labs about the cost of relying on the paper printout and ignoring the metadata and audit trails which remained in the electronic...
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