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Anyone been asked by an auditor if software is certified?

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
Parents
  • Brian,
    I was not offended, just making a point to the tech that I want the ticket open until a final answer is available. The ticket is traceability for me to get an answer. I know of no third party certification either, well, NIST. The TS standard and, I believe other lab certification standards (A2LA, NIST) require software performing measuring, inspection, testing, (all the code words) be reviewed. Statistics in my opinion, would fall under the code word criteria since decisions are made using statistical analysis to improve your final product. In my opinion, maybe an official third party titled organization / company is not needed. Maybe the math and other info can be certified by an educational institution approved by Hexagon? But this is just a guess from me. Hexagon would have to research what all, or at least the major certification bodies accept. I have not had an auditor ask about software since back in the late 90's, but while reviewing our lab scope, this subject was mentioned.
    Another question that was mentioned during our review, how do we check our in use software to assure nothing changed over the coarse of time? We were thinking of a spreadsheet with the formulas from / in the AIAG MSA book, compare the results to the Datapage and see if there are any differences. Like you Brian, I am not an expert, just asking the masses if there is one or two that might have went through this process.

    Odda
Reply
  • Brian,
    I was not offended, just making a point to the tech that I want the ticket open until a final answer is available. The ticket is traceability for me to get an answer. I know of no third party certification either, well, NIST. The TS standard and, I believe other lab certification standards (A2LA, NIST) require software performing measuring, inspection, testing, (all the code words) be reviewed. Statistics in my opinion, would fall under the code word criteria since decisions are made using statistical analysis to improve your final product. In my opinion, maybe an official third party titled organization / company is not needed. Maybe the math and other info can be certified by an educational institution approved by Hexagon? But this is just a guess from me. Hexagon would have to research what all, or at least the major certification bodies accept. I have not had an auditor ask about software since back in the late 90's, but while reviewing our lab scope, this subject was mentioned.
    Another question that was mentioned during our review, how do we check our in use software to assure nothing changed over the coarse of time? We were thinking of a spreadsheet with the formulas from / in the AIAG MSA book, compare the results to the Datapage and see if there are any differences. Like you Brian, I am not an expert, just asking the masses if there is one or two that might have went through this process.

    Odda
Children
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