GMP documents

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    • April 12, 2022 at 5:44 pm #4572
      Christine Evans
      Participant

      Hello, I am currently a CTA on the side of the sponsor. After reviewing the most recent TMF reference model, I and my team are still unsure of where to file GMP documents that are NOT classified on the reference model under section 06.

      My thinking is that if the document in question is not noted in that section then it should be housed elsewhere, other than the TMF. Right now we have a large amount of GMP documents in Veeva Quality Docs. So how can i be sure which GMP documents go in the TMF?

      Thanks,
      Christine

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