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Abstract

ICH Q10 was published in 2008, and presented a model for an effective Pharmaceutical Quality System (PQS). However, the industry still has some way to go in embracing and implementing its principles in order to achieve greater product realisation, to establish and maintain a state of control, and to facilitate continual improvement.

ICH Q10 introduced us to two key enablers: Knowledge Management (KM) and Quality Risk Management (QRM).[1] While the pharmaceutical industry has made progress in implementing the principles of QRM since 2008, there has been significantly slower progress in implementing knowledge management practices. However, there may be solutions available to us today that may very well help speed up this implementation. This journal article looks at how emerging technologies may assist pharmaceutical companies to capture, share and transfer tacit knowledge.

The article focuses on the potential that emerging technology has to harness knowledge that is often difficult to capture, namely tacit knowledge. Paper 1 in this series defines Tacit Knowledge and gives examples. Tacit knowledge is typically acquired through experience, and it is intuitively understood. As this type of knowledge and skill is challenging to articulate in pharmaceutical policies and procedures, it can be difficult to transfer this information to other individuals. However, recent advances in technology may well hold the key to unlocking this illusive and invaluable source of knowledge within our industry. This article explores the benefits of using mixed reality technology (AR/VR) to assist pharmaceutical companies capture, share and transfer knowledge with a focus on KM as applied to technology transfer.

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Creative Commons Attribution-Noncommercial 4.0 License
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