The first such guidance in the pharmaceutical industry, the Guide promotes uniting KM with Quality Risk Management (QRM) to enable better risk-based decisions. It shows how 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. Employing KM methods and tools enables organizations 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 organizations better understand what KM is, the benefits of effective KM, and how to deploy KM
This Guide was written and reviewed by a group of experts in the field, making it a must-have reference to improve your capabilities in managing knowledge and using that knowledge to support an effective PQS resulting in improved PQS outcomes (e.g., better risk-based decision making).
Beyond the quality system, substantial and compelling benefits of effective KM include improved business performance by increasing efficiency, building more robust processes, facilitating continual improvement and creating an engaged knowledge workforce.