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The final requirement in this section includes "...the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary."
Several questions:
1) Test equipment whose operation is computer controlled (in our instance, a spectrometer for chemical analysis) using software developed and installed by the manufacturer. Are we expected to confirm it's acceptability or require some type of documentation from the manufacturer to prove this?
2) What about MS excel spreadsheets and MS access databases employed for logging data, creating SPC charts? Would the software itself require confirmation and/or would each individual spreadsheet created require confirmation?
Thanks for any guidance you can offer.
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Ed Gall
Several questions:
1) Test equipment whose operation is computer controlled (in our instance, a spectrometer for chemical analysis) using software developed and installed by the manufacturer. Are we expected to confirm it's acceptability or require some type of documentation from the manufacturer to prove this?
2) What about MS excel spreadsheets and MS access databases employed for logging data, creating SPC charts? Would the software itself require confirmation and/or would each individual spreadsheet created require confirmation?
Thanks for any guidance you can offer.
------------------
Ed Gall