2 Replies Latest reply on Apr 10, 2018 6:54 PM by ssauder

    Document repository

    cmthomp6

      Can RtReports or another OSI Soft System function as a document repository that is FDA compliant and can store PDF reports for some long compliant period of time? 

        • Re: Document repository
          rschmitz

          Hi Connor,

           

          RtReports is compliant with U.S. 21 CFR Part 11 (Electronic Records and Electronic Signatures). RtReports in itself is not a document repository but rather a generation tool for electronic and printed reports. The data itself that is written into the reports is stored in it's original fidelity on the Data Archive. Can you be more specific on "some long compliant period of time"? The limit of time for the Data Archive storing this data is more dependent on the amount of disk space available to you more than anything else.

           

          I think to better answer your question, we'll need to know exactly which parts of U.S. law/FDA regulation you're referring to though, because there are any number of regulations required on documentation by the FDA not all of which fall under the purview of RtReports reporting capabilities.

           

          Cheers,

          Rob

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          • Re: Document repository
            ssauder

            Hi Connor,

            In addition to the time series data in the PI Data Archive, RtReports also stores the history of any report comments, verifications and approvals. Basically this allows the same report PDF to be generated again when ever needed. As far as a document repository, this is not really what RtReports is designed to be. However, what I have seen customers do in the past is to print the report PDF's to virtual directories on the same IIS website (or a different website on the same web server). This allows all report PDF's to be easily accessed from a web browser. However, what FDA compliant means in this context is also unclear to me, so I am not sure if this solution would fulfill that requirement.

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