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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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  • First, let me preface this by saying I am not the only expert at Hexagon, nor a certifications expert either. But I will state what I know and ask a couple of questions, and I've checked and your ticket was reopened and attached to a problem report with our developers. The only reason it was closed was because you were in direct contact with a developer, they did not mean to offend.

    Questions/statements:

    1. I can find no NIST certification for SPC software. Are you sure one exists?
    2. Do you know of any 3rd party testing for SPC software? I've got to believe one exists, but I can't find one myself in a quick check (again, I don't check these kinds of certifications every day).
    3. Does your auditor require/accept a certain company's tests?


    I am only familiar with NIST and PTB testing for PC-DMIS, I've never been asked for DataPage/SPC software certification as a customer or working for Hexagon (and I've been doing this over 20 years). For fun, I checked the Minitab website, and didn't find any meaningful certifications there for Minitab either.
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  • First, let me preface this by saying I am not the only expert at Hexagon, nor a certifications expert either. But I will state what I know and ask a couple of questions, and I've checked and your ticket was reopened and attached to a problem report with our developers. The only reason it was closed was because you were in direct contact with a developer, they did not mean to offend.

    Questions/statements:

    1. I can find no NIST certification for SPC software. Are you sure one exists?
    2. Do you know of any 3rd party testing for SPC software? I've got to believe one exists, but I can't find one myself in a quick check (again, I don't check these kinds of certifications every day).
    3. Does your auditor require/accept a certain company's tests?


    I am only familiar with NIST and PTB testing for PC-DMIS, I've never been asked for DataPage/SPC software certification as a customer or working for Hexagon (and I've been doing this over 20 years). For fun, I checked the Minitab website, and didn't find any meaningful certifications there for Minitab either.
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