Journal of Developing Drugs
Open Access
ISSN: 2329-6631
+44 1478 350008
ISSN: 2329-6631
+44 1478 350008
Lothar Hartmann
Accepted Abstracts: J Dev Drugs
A new topic arises at the horizon: Knowledge Management. Laid down as a regulatory expectation in the ICH Q10 document if will become an integral part of our daily working culture. Together with ?Quality Risk management?, ?Knowledge management? is seen as enablers for a smoothly operating Pharmaceutical Quality System. But why are we talking about implementation of ?Knowledge Management? into our pharmaceutical business? Regulators discover since long times that industry is not able to provide the right knowledge at the right time. Even if the knowledge is already available in house it is not communicated properly throughout the company. Knowledge is kept in (departmental) silos and is reinvented over and over again at different stages of the lifecycle of a product. Concepts for Knowledge Management are available and widely utilized among other industries. Knowledge Management asks us; ? To systematically capture the information of a product over it?s lifecycle in a way that all relevant employees have access to it in order to prevent reinvention ? To systematically capture the expertise of our employees and sustainably provide this knowledge to the community of the company ? To systematically work on process optimization by constantly taking decisions on the basis of the available in-house information We are asked to find solutions to filter the sheer volume of available data that we collect day by day and utilize it for the benefit of the company under the umbrella of Knowledge Management.