ISPE releases guide to pharmaceutical knowledge management

Published: 21-May-2021

The guide promotes uniting KM with quality risk management (QRM) to enable better risk-based decisions

The International Society for Pharmaceutical Engineering (ISPE) has announced the release of its latest guide, Knowledge Management in the Pharmaceutical Industry. The guide focuses on how knowledge management (KM) can enable a more effective pharmaceutical quality system (PQS).

The guide promotes uniting KM with quality risk management (QRM) to enable better risk-based decisions. It argues KM can enhance nearly every element of the PQS across the product lifecycle.

“Knowledge management focuses on how organizations create, manage, and use knowledge throughout the lifecycle of a product. It, along with QRM, is one of the two enablers of an effective pharmaceutical quality system as defined by ICH Q10,” said Paige Kane, Guide Team Co-Lead, Director Knowledge Management, Merck & Co. “Employing KM methods and tools enables organisations to better manage their knowledge as a key asset, in turn improving the effectiveness of the pharmaceutical quality system, providing operational benefits and more.”

"There are currently few resources, and no industry guidance available which address the role of knowledge management specifically for the pharmaceutical industry. This guide works to demystify KM and provides practical guidance, templates, case studies, and references to related ISPE industry guidance to help organisations better understand what KM is, the benefits of effective KM, and how to deploy KM,” said Melanie Byrne, Guide Team Co-Lead, Knowledge Management Lead, Pfizer.

The guide was written and reviewed by experts in the field and is designed to function as a reference to improve your capabilities in managing knowledge and using that knowledge to support an effective PQS for better outcomes.

Beyond the quality system, ISPE argues, the benefits of effective KM include improved business performance by increasing efficiency, building more robust processes, facilitating continual improvement and creating an engaged knowledge workforce.

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