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Abstract

As part of research to better define and improve the integration between quality risk management (QRM) and knowledge management (KM) as dual enablers of an effective pharmaceutical quality system, a survey was conducted in February 2021 to explore this relationship. The survey explored the current state relationship in theory and in practice, solicited feedback on a proposed framework, the Risk-Knowledge Infinity Cycle, to improve the connection between QRM and KM, associated benefits and potential actions to make progress in this regard. The results suggest QRM and KM are highly interdependent in theory but much less so in practice. Further, there is broad interest to improve this QRM-KM connection, leading to an array of potential benefits. The framework proposed to improve the connection is viewed positively and will be further advanced.

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Creative Commons Attribution-Noncommercial 4.0 License
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