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.
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.
Table I: Data encountered by key personnel in the biopharmaceutical industry.
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
- Knowledge structure.
KNOWLEDGE MANAGEMENT IMPLEMENTATION PROCESS
Phase 1: Identification of data and information
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.
Figure 2: Various business lines in the biopharmaceutical industry.
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.