I am new to SASUnit and would like to use it for a GxP validated environment. Is there are documentation that can be provided for the testing that has been done for the different SAS versions/Operating systems that are listed on the System Requirements page?
My apologies in advanced if I missed them in the repository.
Thanks
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as far as I understoop it, the use a SASUnit is rated as a tool. Your are just testing your programs with it. SASUnit is not part of your execution environment.
So it should be sufficient to provide an Installation Qualification (IQ) and an operaational qualification (OQ). Executing the SASunit example project and comparing the results to the documentation on Source Forge is sufficient for an OQ.
If You see it differently I will ask our Gxp experts and computer validation specialists.
Hope this helps.
Regards
Klaus Landwich
If you would like to refer to this comment somewhere else in this project, copy and paste the following link:
Anonymous
Anonymous
-
2020-08-28
This makes sense, thank you for the the explanation.
If you would like to refer to this comment somewhere else in this project, copy and paste the following link:
Hi,
I am new to SASUnit and would like to use it for a GxP validated environment. Is there are documentation that can be provided for the testing that has been done for the different SAS versions/Operating systems that are listed on the System Requirements page?
My apologies in advanced if I missed them in the repository.
Thanks
Hi there,
as far as I understoop it, the use a SASUnit is rated as a tool. Your are just testing your programs with it. SASUnit is not part of your execution environment.
So it should be sufficient to provide an Installation Qualification (IQ) and an operaational qualification (OQ). Executing the SASunit example project and comparing the results to the documentation on Source Forge is sufficient for an OQ.
If You see it differently I will ask our Gxp experts and computer validation specialists.
Hope this helps.
Regards
Klaus Landwich
This makes sense, thank you for the the explanation.