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

Viewing 4 reply threads
  • Author
    • #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.

    • #3797
      Bert Peeters

      Hi All,

      Just wondering if others have another opinion about this. Personally I would file study specific CAPA forms in the TMF.

      Many thanks,

    • #3802
      Mariz Hanna

      Hi Katie,
      This should not be in TM. It should be filed in quality management system.

    • #3837
      Amanda Noel

      Hi All –

      I’m also interested in this chain as I have heard both suggestions. File CAPAs if they help tell the story of the TMF or show Sponsor Oversight. I have also heard not to file them and place in QA files like QMS. What about site level CAPAs?


Viewing 4 reply threads
  • You must be logged in to reply to this topic.