Journal of Engineering, Computers & Applied Sciences (JEC&AS) Volume 2, No.11, November 2013

ISSN No: 2319-5606

Electronic Lab Notebooks-Collaborative Tool for Managing Knowledge in Pharmaceutical Research and Development M. Joseph Kiran Kumar, General Manager (IT), Eisai Pharmatechnology and Manufacturing Pvt. Ltd, Visakhapatnam, AP. India

Abstract Laboratory notebooks represent an important part of pharmaceutical research and development (R&D) workflow as they are the witnesses for the quality of the work carried out in the laboratories. Laboratory notebooks have always played a vital role in ensuring that repeatable steps could be easily identified and identifying those steps, which did not result in the desired outcome. Laboratory note books have been traditionally paper based; the work was handwritten and stored in secured cabinets.

1. Introduction Traditional Laboratory Notebooks Laboratory notebooks represent an important part of pharmaceutical research and development (R&D) workflow as they are the witnesses for the quality of the work carried out in the laboratories. Laboratory notebooks have always played a vital role in ensuring that repeatable steps could be easily identified and identifying those steps, which did not result in the desired outcome. Laboratory note books have been traditionally paper based; the work was handwritten and stored in secured cabinets. From the organization’s perspective a lab notebook is used as a repository of the activities carried out in pharmaceutical research laboratories. It also serves the purpose of being used as a legal document for patent prosecution and intellectual property litigation, which are critical tasks in pharmaceutical research organizations. However, there were few limitations of Paper based Laboratory notebooks - notable among them are as follows: a)

the whole exercise considering the space these notebooks occupy. d) With paper based electronic laboratory notebooks it is a real challenge not only to setup a reference between the notebooks but also to re analyze data in the notebooks. e) These paper based lab notebooks would cause hindrance for the research workgroups to carry out research in a collaborative manner especially when the groups are scattered geographically f) It is observed that around 20-40% of the researcher’s productive time is wasted in non productive activities such as looking up for information, undertaking administrative activities, making entries in the notebooks etc (Source: Atrium research)

Electronic Laboratory Notebooks Features and benefits that Information and computer technology (ICT) offered have encouraged researchers to embrace technology thereby paving the way for the usage of ICT in R&D. Application of ICT in R&D contributed to the revolutionary change in the way researchers manage their research work.

Manual laboratory notebooks are poor communicators and reveal information only when someone looks for the information intently. They don’t present much scope to record tacit information such as ideas and experiences b) Most of the time, one cannot know what has been accomplished in earlier research studies unless one scans through the volumes of paper records. Therefore many research man hours spent might not actually result in the desired outcome. c) Maintaining such high volumes of paper based laboratory notebooks means setting aside lot of space, besides accepting the risks that are associated with the paper based information assets such as wear and tear, addressing problems associated with access control and bearing the expenses to manage

Electronic Laboratory notebook Enterprise streamlines the daily record-keeping of research scientists. With the advancement in technology, today’s Electronic lab notebooks allow scientists to capture and store many types of data, including MS Office data (Word, Excel, and PowerPoint), chemical structure data, and images.

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Electronic laboratory notebooks, with clear advantages to the researcher in terms of multimedia inputs, automation of entries, location independence, group access, etc., have successfully made their way into the pharmaceutical research laboratories as they promise an alternative to manual laboratory notebooks. Additionally, there have been advancements in scientific research—towards distributed project teams, discoveryand informatics-based research and large-scale

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Journal of Engineering, Computers & Applied Sciences (JEC&AS) Volume 2, No.11, November 2013

ISSN No: 2319-5606

coordination of efforts which reiterates the evolving collaborative framework in research.

Knowledge is a human process which cannot be easily replicated.

Thanks to the persistent enhancements expected from the customers, they have made Laboratory notebook manufacturing companies come up with the notebooks which are quite flexible. These notebooks come with configuration interface through which organization specific processes are captured in a methodical manner and also help the organization to set up diverse workflows of the researchers across various functional areas.

Tacit knowledge represents internalized knowledge that an individual may not be consciously aware of, such as how he or she accomplishes particular tasks. At the opposite end of the spectrum, explicit knowledge represents knowledge that the individual holds consciously in mental focus and in a form that can easily be communicated to others.[10] (Alavi & Leidner 2001). Similarly, Hayes and Walsham (2003) describe content and relational perspectives of knowledge and knowledge management as two fundamentally different epistemological perspectives. The content perspective suggests that knowledge is easily stored because it may be codified, while the relational perspective recognizes the contextual and relational aspects of knowledge, which can make knowledge difficult to share outside of the specific location where the knowledge is developed.

Paradigm shift New Trends in scientific research—such as distributed project teams, discovery- and informatics-based research, tight uncompromising timelines, large-scale coordination of efforts, Collaboration of teams beyond the boundaries and Grid-based virtual organizations— bought to the forefront the needs of the pharmaceutical research organizations. These requirements have essentially raised the curtain over the need for a variety of technologies that organizations strive to adopt by doing what they are best at and by the means of retaining the very crux of their existence – knowledge. Knowledge is a familiarity with someone or something, which includes facts, information, descriptions, or skills acquired through experience or education. It can also refer to the theoretical or practical understanding of a subject.

Managing knowledge in R&D It is important to understand that Knowledge management (KM) comprises of a range of strategies and practices used in an organization to identify, create, represent, distribute, and enable adoption of insights and experiences. Such insights and experiences comprise knowledge, either embodied in individuals or embedded in organizations as processes or practices. Knowledge management can primarily be differentiated into two parts: one that tends to focus on knowledge sharing, and the other that tends to focus on knowledge making. Both the knowledge sharing and knowledge making parts go hand in hand. They both are equally crucial for the organization to manage, as knowledge making connects Knowledge management and Innovation management whereas Knowledge sharing connects knowledge management with Organizational Learning (OL) Pharmaceutical R&D organizations have to deal with both - the individual and organizational knowledge. During the research process it may seem that knowledge is a mere compilation of facts but it is more than that.

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Although, the idea of tacit knowledge intuitively makes sense to most people, the management often has a hard time coming to grips with it. Recognizing the value of tacit knowledge and figuring out how to use it is the key challenge in a knowledge-creating environment such as a Research and Development company, one that requires extended conversations and good personal relationships—that is, knowledge enabling. Early research suggested that a successful KM effort needs to convert internalized tacit knowledge into explicit knowledge in order to share it. However, the same effort must also permit individuals to internalize and make any codified knowledge retrieved from the KM effort personally meaningful..

ELN as a knowledge management Tool Tacit knowledge makes a powerful tool for innovation. R&D organizations have figured out that Knowledge management acts as a catalyst in achieving organizational objectives such as improved performance, advantage, innovation, the sharing of lessons learnt, integration and continuous improvement of the organization. Knowledge management efforts overlap with organizational learning. Yet the distinguishing factor between them is the KM efforts’ greater focus on the management of knowledge as a strategic asset and a focus on encouraging the sharing of knowledge. R&D organizations have researchers, who share their knowledge of a given product area. This knowledge is mostly tacit, includes insights into the research information such as new processes and also personal skills that are required to perform the tasks The general goal is to create a tangible manifestation of the team’s knowledge. Finally, the team assumes

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Journal of Engineering, Computers & Applied Sciences (JEC&AS) Volume 2, No.11, November 2013

responsibility for sharing its knowledge with the organization at large. ELNs facilitate the sharing of such tacit knowledge which the teams create as a new product, the concept may be a specification of functionality, an algorithm, a manufacturing-process description, drawings, and so on. The Electronic note book is not just a digital version of the laboratory notebook. It facilitates the protection of organizations intellectual property. ELN is a knowledge repository that allows for collaboration, sharing of explicit as well as tacit knowledge and meets legal and regulatory requirements. Electronic lab notebooks act as a good source of knowledge creation and sharing as they enable data to be collected, stored and retrieved through any combination of forms thus meeting the requirements of the researcher. The extensive searching capability allows organizations to leverage their knowledge base more effectively. Managing knowledge especially during drug development is crucial as the chemistry conducted during this stage is more repetitive than that conducted during drug discovery, and much time is spent duplicating procedures. Transcribing and updating an existing procedure is expensive, time-consuming, tedious and error-prone. ELNs come very handy in this stage of research as significant gains are seen in terms of reduction in time lines and realizing true value of investment.

Managing Knowledge

Innovation

By

Managing

Recognizing the value of tacit knowledge and figuring out how to use it is the key challenge for the research organization. Tacit knowledge may seem too mysterious as no one understands it’s potential. However over time, expectations from tacit knowledge have been clearly defined in a particular situation due to which this knowledge could turn into a powerful tool for innovation. Then again, the challenge would be to use such a tool in a diligent manner. Knowledge management efforts have a long history, which includes on-the-job discussions, formal apprenticeship, discussion forums, corporate libraries, professional training and mentoring programs to realize and transmit tacit knowledge. Now Electronic laboratory notebooks have further enhanced such efforts.

As the Electronic Laboratory notebooks grow more collaborative in nature, pharmaceutical R&D has moved

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from the current limitations of knowledge-management theory to discuss practical and amorphous approaches thus constantly evolving the human realm of knowledge. ELN’s by virtue of their collaborative features enable knowledge creation by a) b) c) d) e)

instilling knowledge vision, managing conversations, mobilizing knowledge activists, creating the right context, and globalization of local knowledge.

Implementation of KM tools such as ELNs are part of the knowledge management strategy, which enrich micro communities of knowledge by harnessing individual and organizational knowledge.

Motivation for Electronic Lab notebook Implementation A number of claims exist as to what are the motivations that encourage leading organizations to undertake a Knowledge management effort such as implementation of Electronic lab notebooks. Few of them include: a)

Making available increased knowledge content in the development and provision of pharmaceutical products and services b) Achieving shorter new product development cycles c) Facilitating and managing innovation and organizational learning d) Leveraging the expertise of people across the organization e) Increasing network connectivity between internal and external researchers f) Managing environments and allowing employees to obtain relevant insights and ideas appropriate to their work g) Managing intellectual capital and intellectual assets in the workforce

ELNs and Compliance ELNs today have more secure forms of data input directly from PCs and other processing devices such as laboratory balances, pH meters, etc. The features of ELNs have been enhanced allowing data to be interrogated, tabulated, checked, approved, stored and archived to comply with the latest regulatory guidance and legislation. The development of these capabilities has been partially guided by regulations such as the FDA’s CFR 21 Part 11 standard for electronic signatures and Good Laboratory Practice (GLP) standards. Additionally, work within the Collaborative Electronic Notebook Systems Association (CENSA) has been used to define requirements for ENs as records systems. Academic research on the mapping

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Journal of Engineering, Computers & Applied Sciences (JEC&AS) Volume 2, No.11, November 2013

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[1] Maloney, A.D.; J.L. Skidmore; M.J. Sottile. 1999.

―Computational Experiments Using Distributed Tools in a Web-Based Electronic Notebook Environment, High-Performance Computing and Networking, Proceedings, No. 1593: 381-390. [2] "Information Architecture and Knowledge Management". Iakm.kent.edu. Archived from the original on June 29, 2008. http://web.archive.org/web/20080629190725/http://i akm.kent.edu/programs/information-use/iucurriculum.html. Retrieved 15 January 2010. [3] Hayes, M.; Walsham, G. (2003). Knowledge sharing and ICTs: A relational perspective In M. EasterbySmith and M. A. Lyles (Eds.), The Blackwell handbook of organizational learning and knowledge management. Malden, MA: Blackwell. pp. 54–77. ISBN978-0-631-22672-7. [4] Gupta, Jatinder; Sharma, Sushil (2004). Creating Knowledge Based Organizations. Boston: Idea Group Publishing. ISBN1-59140-163-1. [5] "Knowledge Management". www.systemsthinking.org. http://www.systemsthinking.org/kmgmt/kmgmt.htm. Retrieved 26 February 2009. [6] .Alavi, Maryam; Leidner, Dorothy E. (1999). "Knowledge management systems: issues, challenges, and benefits". Communications of the AIS 1 (2). http://portal.acm.org/citation.cfm?id=374117. [7] Alavi, Maryam; Leidner, Dorothy E. (2001). "Review: Knowledge Management and Knowledge Management Systems: Conceptual Foundations and Research Issues". MIS Quarterly 25 (1): 107–136. DOI:10.2307/3250961. JSTOR3250961. http://web.njit.edu/~jerry/CIS-677/Articles/AlaviMISQ-2001.pdf. [8] Booker, Lorne; Bontis, Nick; Serenko, Alexander (2008). "The relevance of knowledge management and intellectual capital research". Knowledge and Process Management 15 (4): 235–246. DOI:10.1002/kpm.314. http://foba.lakeheadu.ca/serenko/papers/Booker_Bo ntis_Serenko_KM_relevance.pdf. [9] Davenport, Tom (2008). "Enterprise 2.0: The New, New Knowledge Management?". Harvard Business Online, Feb. 19, 2008. http://discussionleader.hbsp.com/davenport/2008/02 /enterprise_20_the_new_new_know_1.html. [10] Ferguson, J (2005). "Bridging the gap between research and practice". Knowledge Management for Development Journal 1 (3): 46–54. [11] Gupta, Jatinder; Sharma, Sushil (2004). Creating Knowledge Based Organizations. Boston: Idea [12] Liebowitz, Jay (2006). What they didn't tell you about knowledge management. pp. 2–3. [13] McAfee, Andrew P. (2006). "Enterprise 2.0: The Dawn of Emergent Collaboration". Sloan Management Review 47 (3): 21–28. http://sloanreview.mit.edu/the-

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between paper and electronic records, supported with ongoing discussions with records managers and intellectual property specialists within the DOE national laboratories, further guides the development of the ENs capabilities. Regardless of the school of thought, core components of KM, depending on the specific perspective, include people, processes, technology .With this universal understanding that these three forms a successful triangle technology such as ELNs would enable better and quality research.

Conclusion The discussion above emphasizes that Electronic Lab Notebooks have the capability of managing the knowledge of the R&D organization effectively through their collaborative features. As EN research continues and additional types of functionalities are being developed (e.g., support for laboratory workflow, federation with other data management systems, management, analysis, and mining agents), theoretical barriers to maintain records capabilities do not appear. Development of additional capabilities for administrating multiple notebooks, monitoring use, enforcing signing and witnessing policies, etc., are being focused upon by the ELN notebook creators to reduce overall systems cost. In addition to the objective of making the ELNs more acceptable from the regulatory point of view, these companies are putting their best efforts in meeting the guidelines of regulatory authorities especially in the form of signatures, timestamps and evidence of logging stronger than the paper based lab notebooks. Electronic lab notebooks have now come of age as they are being built with productivity, collaboration and records requirements in demand from the pharmaceutical researchers. Open source ELNs are evolving in the marketplace thereby giving an opportunity for the R&D organizations to have a peek inside those systems before they make a decision to go with one. Organizations need to understand that knowledge creation and knowledge sharing in the organization is an effort that encompasses people, processes and technology. ELNs provide a platform for the people to manage knowledge processes effectively. Effective management of knowledge brings in benefits to the pharmaceutical R&D organizations by giving them an edge in all the phases of R&D research through collaboration facilitated by ELNs.

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Krogh, Georg von; Ichijo, Kazuo; Nonaka, Ikujiro (2000-06-01). Enabling Knowledge Creation: How to Unlock the Mystery of Tacit Knowledge and Release the Power of Innovation (Kindle Locations 153-167). Oxford University Press. Kindle Edition

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