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Anyone been asked by an auditor if software is certified?

oddam
Going through out TS audit, revamping our lab scope, all the good stuff. Has anyone ever been asked about their software per the TS standard? I was asked in the mid 90's under a different audit format, but nothing since. I found PCDMIS is NIST certified, but not Datapage? Hexagon promotes Datapage compliant to FDA Part 11. I submitted a ticket, Hexagon is reviewing the issue. I was just wondering if anyone has been through the software portion of the audit? I was also told that the certification must be at least annual, even if the software proved out in the past by Hexagon. I can understand the proving out in case of possible issues over time. How have you proved the software is proper, if you have?

Odda
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  • NIST, to our knowledge (checking everything we know so far) does not certify SPC software, only measurement software. I'm hoping to be corrected soon on that, we like getting certifications (I do), it's another form of testing.

    DataPage does not "measure", "inspect", or "test". It simply summarizes data produced by measurement/testing software. Now I agree there are calculations that could be certified in there that are not trivial, but they are also not that hard to correlate either.

    Educational institutes have no accreditation of their own (that I am aware of...) that would qualify them for this testing except maybe for marketing purposes, so that's not a valid route.


    For your last question, an artifact, a checking gauge, a virtual measurement program are all variations on things I have seen used to verify software "not changing".

    I will report more when we hear back from our contacts in this arena.
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  • NIST, to our knowledge (checking everything we know so far) does not certify SPC software, only measurement software. I'm hoping to be corrected soon on that, we like getting certifications (I do), it's another form of testing.

    DataPage does not "measure", "inspect", or "test". It simply summarizes data produced by measurement/testing software. Now I agree there are calculations that could be certified in there that are not trivial, but they are also not that hard to correlate either.

    Educational institutes have no accreditation of their own (that I am aware of...) that would qualify them for this testing except maybe for marketing purposes, so that's not a valid route.


    For your last question, an artifact, a checking gauge, a virtual measurement program are all variations on things I have seen used to verify software "not changing".

    I will report more when we hear back from our contacts in this arena.
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