Knowledge Management Implementation - The authors discuss the technology and guidance required to achieve good knowledge management in a biopharmaceutical company. - BioPharm International

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Knowledge Management Implementation
The authors discuss the technology and guidance required to achieve good knowledge management in a biopharmaceutical company.


BioPharm International
pp. 50-55

Knowledge management

Knowledge management has emerged as an area of interest in organizational practice. According to Malhotra,

"KM embodies organizational processes that seek synergetic combination of data and information processing capacity of information technologies, and the creative and innovative capacity of human beings (4)."

Backman defines KM as

"the formalization of and access to experience, knowledge, and expertise that create new capabilities, enable superior performance, encourage innovation, and enhance customer value (5)."

Thus, KM can be defined as a systematic management of all activities and processes referring to development, storage, sharing, and utilization of knowledge for an organization's competitive edge.

Reasons for knowledge management implementation

The amount of data that a person in pharmaceutical company handles is extremely large and is rapidly growing. Table I shows data encountered by different people in a typical biopharmaceutical company. Looking at the complexity of data faced by people at different levels, adoption of KM in the organization becomes imperative. A successful KM approach helps to better organize data, which further facilitates data analysis and interpretation. Furthermore, the business environment is getting more demanding because of a number of factors, including:

  • Increasing number of competitors
  • Market requirement of drugs
  • Increase in number of antibiotics, vaccines, and biosimilars
  • Advancement of technology
  • New regulatory guidelines.


Table I: Data encountered by key personnel in the biopharmaceutical industry.
This complexity has made it important for an organization to respond quickly and effectively to changing environmental conditions. To maintain a competitive advantage, a company's data must be structured in a traceable way. This can be achieved through the implementation of KM in an organization.

Crucial factors for success

There are several key variables for successful implementation of KM. They are as follows:

  • Employee learning and development
  • Organizational infrastructure
  • Technology infrastructure
  • Knowledge-friendly culture
  • Senior management support and commitment
  • Information-systems infrastructure
  • Teamwork
  • Knowledge structure.

KNOWLEDGE MANAGEMENT IMPLEMENTATION PROCESS

Phase 1: Identification of data and information


Figure 2: Various business lines in the biopharmaceutical industry.
In a typical biophamaceutical company there are various business lines as shown in Figure 2. The first phase of the KM implementation process includes conducting brainstorming sessions at several randomly selected meetings at different levels with different business lines such as R&D research group meetings, individual personal dialogue, or meeting with production officers. Through these meetings, information and data that are not yet recognized and systemized can be identified. For example, meeting with a production officer to discuss various process parameters of a chromatography process may help to monitor and record these process parameters in a systematic way, or meeting with a research group to discuss the characterization process of a particular molecule may aid in the documentation of the characterization process in a systematic way.

Phase 2: Identification of data storage process

This phase involves identification of various processes being followed by various people at different business lines. The process includes going through existing standard operating procedures for different processes, or examining process flow sheets and finding how the data is being stored.

Phase 3: Identification of data storage location

Based on findings from phases 1 and 2 the data locations are identified and listed. Storage locations can include corporate databases where relevant data is stored in the organization. These locations can be computer hard drives, USB drives, CD-ROMs, paper files, or corporate databases.


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