International Comparison of Qualification Process for Medical Product Development Tools.
Daichi UchijimaShingo KanoPublished in: Therapeutic innovation & regulatory science (2024)
It was indicated that in the GoG type policy, in which processes are defined, and involvement methods are clarified, tool qualification can progress more smoothly than in a non-GoG type policy. This policy indicates that deliverables may have a consistent composition. Contrastingly, GoG-type policies alone present challenges in connecting upstream tools for R&D support.
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