Knowledge Management (KM): Is the Industry Ready for it?


The most recent publication of ISPE Good Practice Guide on Knowledge Management (KM) brought once more to the attention the need to have the best practices established when it comes to KM Framework implementation. 

In this blog post, we’ll go through some concepts on Knowledge Management.  So, if this is a topic of interest to you, stay with us! 


Let’s Start With a Little Context! 


It’s not new that, in the last years, the Pharmaceutical Industry has invested a considerable amount of effort in implementing QRM principles. 

As a result of those efforts, many companies have now mature systems and are putting into practice science risk-based approaches. We use science risk-based approaches systematically throughout drug substance and drug product lifecycles.  

However, when we talk about Knowledge Management the situation is a bit different and this compromises the application of ICH Q10 guideline, where QRM and KM are described as enablers. 

Yes, we know that ICH Q10 was implemented a few years after ICH Q9. But there are still some gaps to make its application a reality. 


Why are Things not Flowing so Well With Knowledge Management? 


Despite delivering many advantages to the business, Knowledge Management has some complexity that works as a major roadblock for its implementation. 

In our point of view, the barrier on the successful adoption of digital solutions like Knowledge Management is not technology but, instead, people.  And it is easy to understand the reason for that:

People need to recognize the value of the knowledge about their products and processes, looking at them as valuable assets. 

So, that’s where we arrived at a fundamental steppingstone for a digital-enabled KM: the need for the establishment of an organizational culture that values knowledge.  


What Kind of Technologies can Help you Implementing a Knowledge Culture? 


The main objective of a digital KM solution starts with collecting and accumulating, storing and archiving it, until sharing and analyzing the information and knowledge. These steps will lead the companies to a final goal: having a clear process and product vision across its lifecycle.  

There are some technologies that can help you implementing a knowledge culture in your organization, such as: 

  • Advanced analytics.
  • Artificial Intelligence. 
  • GxP regulated cloud computing. 
  • Virtual and Augmented Reality. 
  • Industrial Internet of Things (IIoT). 
  • Blockchain. 

These technologies will be useful to leverage the power of knowledge inside your organization. 


So, why is it Important to Create a Knowledge Culture in Your Organisation?


Keep in mind: the first step for a knowledge management implementation is creating a knowledge culture!  The creation of a knowledge culture in the heart of organizations will provide a competitive edge and will create a source of value.   

Only when knowledge culture is created, there will be conditions to implement the necessary processes and technologies for an effective and capable system to meet the specific business objectives of any organization. 


The opinions, information and conclusions contained within this blog should not be construed as conclusive fact, ValGenesis offering advice, nor as an indication of future results.