hexagon logo

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
  • Here is an update on my question concerning Datapage. I just think anyone who might need this info in the future will at least have some idea about it.

    My name is Joseph Batts, Product Owner for Web Reporting applications, including DataPage+ and WebReporter. I received notification of a ticket you submitted asking about NIST 3rd party certification for DataPage+. The calculations used in DataPage+ were certified 25 years ago using recognized industry SPC standards then, which have not changed. However, no additional certification has been performed and documented since. That being said, your request is one of several for the same or similar certification. In May 2014, I started a project to gain this 3rd party certification for DataPage+ and WebReporter, and it is in the works. When the applications are certified, and publishable documentation is available, it will be made available on the PC-DMIS website for DataPage+ ( http://www.pcdmis.com/products/datapage-plus-spc).

    If you have additional questions, please feel free to call me. I will be happy to help in any way I can.

    Best regards,

    Joseph Batts
    Product Owner – Web Reporting
    (MMS, DataPage+, WebReporter, DataGage+)
    Wilcox Associates, Inc.

    I then received this email from Hexagon.

    From: Hexagon Metrology - Technical Support [mailto:Support@HexagonMetrology.us]
    Sent: Wednesday, July 16, 2014 4:30 PM

    Your ticket has been closed.
    Please follow up on this issue with Joseph Batts directly as he emailed you earlier today.

    My response to the closed ticket.

    Why should this ticket be closed? My (Iroquois) support is through Hexagon, not Joseph Batts. I can only ask the software that was purchased through Hexagon be accredited to a recognized national standard. If Hexagon contracted with Joseph Batts for statistical software, would it not make sense that Hexagon expect the software to be certified to a recognized national standard when changes (upgrades or fixes) are made or a certain time period is reached, just like PCDMIS is? Please tell me how I would answer an auditor if they asked about the software? Show the email that the software was certified 25 years ago? This ticket should remain open until Mr. Batts finishes his statement “In May 2014, I started a project to gain this 3rd party certification for DataPage+ and WebReporter, and it is in the works. When the applications are certified, and publishable documentation is available, it will be made available on the PC-DMIS website for DataPage+”. I would respectfully ask that this ticket remain open so I can be notified when the 3rd party cert is available. If there are any concerns with this ticket being open, please send it to a higher authority to answer it with me.
Reply
  • Here is an update on my question concerning Datapage. I just think anyone who might need this info in the future will at least have some idea about it.

    My name is Joseph Batts, Product Owner for Web Reporting applications, including DataPage+ and WebReporter. I received notification of a ticket you submitted asking about NIST 3rd party certification for DataPage+. The calculations used in DataPage+ were certified 25 years ago using recognized industry SPC standards then, which have not changed. However, no additional certification has been performed and documented since. That being said, your request is one of several for the same or similar certification. In May 2014, I started a project to gain this 3rd party certification for DataPage+ and WebReporter, and it is in the works. When the applications are certified, and publishable documentation is available, it will be made available on the PC-DMIS website for DataPage+ ( http://www.pcdmis.com/products/datapage-plus-spc).

    If you have additional questions, please feel free to call me. I will be happy to help in any way I can.

    Best regards,

    Joseph Batts
    Product Owner – Web Reporting
    (MMS, DataPage+, WebReporter, DataGage+)
    Wilcox Associates, Inc.

    I then received this email from Hexagon.

    From: Hexagon Metrology - Technical Support [mailto:Support@HexagonMetrology.us]
    Sent: Wednesday, July 16, 2014 4:30 PM

    Your ticket has been closed.
    Please follow up on this issue with Joseph Batts directly as he emailed you earlier today.

    My response to the closed ticket.

    Why should this ticket be closed? My (Iroquois) support is through Hexagon, not Joseph Batts. I can only ask the software that was purchased through Hexagon be accredited to a recognized national standard. If Hexagon contracted with Joseph Batts for statistical software, would it not make sense that Hexagon expect the software to be certified to a recognized national standard when changes (upgrades or fixes) are made or a certain time period is reached, just like PCDMIS is? Please tell me how I would answer an auditor if they asked about the software? Show the email that the software was certified 25 years ago? This ticket should remain open until Mr. Batts finishes his statement “In May 2014, I started a project to gain this 3rd party certification for DataPage+ and WebReporter, and it is in the works. When the applications are certified, and publishable documentation is available, it will be made available on the PC-DMIS website for DataPage+”. I would respectfully ask that this ticket remain open so I can be notified when the 3rd party cert is available. If there are any concerns with this ticket being open, please send it to a higher authority to answer it with me.
Children
No Data