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Intelligent Report in external audits

oscarmcl

Hello,


In my company we are replacing the Excel spreadsheets with the Agilent intelligent report but we have a question regarding the external audits.
How can we prove that the calculation made by the intelligent report is correct? So far what we have done is compare the result of the intelligent report with that of the spreadsheet. Does the software have any option to show the formulas that are used in the report?

Does anyone know what they usually ask for in this type of audit?

Thank you!
Òscar

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  • 0

    Hello,

    You can use the document template to show the embedded calculations, variables and parameters in a template but it does create a large document even for a simple template. The typical method of validation is to compare several results sets using your current calculation methodology versus the report template. Once this is done and the template results match your current method within the limits specified you can lock the template from further editing. The documentation of this procedure would be up to your companies SOPs.

    Marty

  • 0 in reply to martin.adams

    Hello

    This is also how we do our "validation" of our report templates.
    We write a report that contains all info of the template, calculations, variables, all that stuff.
    Then we compare a previously analysed (and reviewed/approved) result set with the report to see if all the data matches, this is also put into the report.
    Lastly, the template is moved to a location where all lab technicians can access it. However nobody can make changes to report templates in this location.

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  • 0 in reply to martin.adams

    Hello

    This is also how we do our "validation" of our report templates.
    We write a report that contains all info of the template, calculations, variables, all that stuff.
    Then we compare a previously analysed (and reviewed/approved) result set with the report to see if all the data matches, this is also put into the report.
    Lastly, the template is moved to a location where all lab technicians can access it. However nobody can make changes to report templates in this location.

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