Software Validation - GageTrak Calibration Software - Please Help

[cbearden]

Software Validation.....What is this?...
Here at work we purchased a copy of GageTrak Calibration software.
We purchased it 3 months ago and haven't started using it. When
you try to open the software, it is password protected and only the
IT folks can get in. When I ask the IT folks and the QA Manager
what the problem is, they say "You can't use it until we get it validated"
What kinda crap is that????.......I mean I understand proving out
a software package that has a DIRECT impact on quality but even then,
how do you validate a software package?....
It seems to me that you select a software you want and buy it...then when it
comes in, if its what you want USE IT.....

Can anyone give me some clarification on this?

Thanks,
ZeissUSer

[The Moose]

To validate our SPC & MSA software we took examples from the AIAG SPC manual and MSA manual put them into the software and then checked against the results from the book and hey presto software validated, for calibration software I would guess it would depend on wether it's simply a database of when things were calibrated in which case there is not a lot to validate other than the software flagging up at the right time, however if your software actually gives a methodology for carrying out say a digital caliper calibration and then carries out calculations, the software output would need to be compared to a proven standard

[Jim Wynne]

Some of the work has already been done. Have a look here:

GageTrak Validation Guide

[cbearden]

Thank you very much for that link......very helpful.....thanks

Zeissuser

[Hershal]

Gagetrak is a COTS package and should be considered validated already, in particular for the application it is designed for. At least, that is the approach for well established software as typically applied in ANSI/ISO/IEC 17025.

If you are working under some other standard that may not be true however.

Hershal

[Al Rosen]

FDA requires the end user to validate COTS software. Look at General Principles of Software validation.

[Jim Wynne]

Originally Posted by Hershal

Gagetrak is a COTS package and should be considered validated already, in particular for the application it is designed for. At least, that is the approach for well established software as typically applied in ANSI/ISO/IEC 17025.

If you are working under some other standard that may not be true however.

Hershal

For the benefit of people like me who didn't know what "COTS" stands for, it's Commercial Off-The-Shelf software.