CAPAs: To File or Not to File

Home Forums Where do I file…. ? CAPAs: To File or Not to File

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    • #3737
      Katie Kelly

      Does anyone recommend filing final CAPAs (vendor, CRO, or Sponsor owned) in the TMF?

      For vendor or CRO owned CAPAs that aren’t filed in the TMF, where do you keep them?

      Thank you!

    • #3752
      Jennifer Gaskin

      No, this should not be in the TMF. It should be filed within your quality management system and/or CAPA tracking system. External CAPAs need to be filed also so that you show oversight. Again, should be in the QMS.

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