Summary, references and further reading Building a Smart Laboratory 2012 Summary


Te concept of a smart laboratory will vary from organisation to organisation depending on the nature of its business and the technological choices it makes. Discovery and development are increasingly recognised as two steps in a holistic product life-cycle process rather than standalone functions. Innovation itself has moved on from ‘Eureka


moments’ and chance discoveries to become a managed industrial process with an in-built need to address quality, regulatory, health and safety, and IP requirements. Just doing the science isn’t enough anymore. With this increasing demand for


competency in science, technology and process understanding, an area of concern is how well adapted we as laboratory workers are to fulfilling industry’s needs. Te view is oſten taken that the demographic problems associated with ‘technology literacy’ will be resolved by


attrition; new laboratory workers joining the organisation will have grown up in a digital world (digital natives). To some extent this is true, but technology continues to evolve at an ever-increasing rate and today’s digital natives may find themselves challenged to keep up with further advances in technology, in the same way today’s digital immigrants are. It’s not just a basic competency in technology


skills that is needed, but also a deeper understanding of the continually evolving strategic and tactical roles that technologies play in the laboratory, both in terms of the science and the processes. Understanding how to use technology is only part of the answer; understanding why and ensuring that the right technologies are applied to the right processes is another matter. Building a smart laboratory is dependent on three major criteria: deploying the right


technologies, developing the right laboratory processes and creating the right culture. Keeping these three criteria in balance is fundamental to success. Perhaps the most critical issue is that of culture. Unfortunately this cannot be created or forced. As much as management may expect or demand their workforce develop a successful workplace culture, all that can be done is to create the right environment that will allow the culture to evolve. Tis can take a long time and, unfortunately, can be destroyed in minutes. Te focus of the guide has been on


technology, in the form of laboratory informatics, with due consideration to the lab processes to which it can be applied. We have touched on some aspects of culture and technology adoption, but it must be remembered that almost every systems project defines user acceptance as a critical success factor. Technology on its own cannot do it.


References and further reading References


1. Scott Jenkins, Pittsburgh Conference presentation on Paperless Laboratory, 2004


2. CENSA: Te Collaborative Electronic Notebook Systems Association


3. Atrium Research: www.atriumresearch.com 4. Te Gartner Hype Cycles: www.gartner.com 5. Good Automated Manufacturing Practice Guidelines version 5, International Society for Pharmaceutical Engineering, Tampa FL, 2008


6. McDowall, R.D., Spectroscopy Focus on Quality, July 2009, p23


7. Using Electronic Records in Patent Proceedings, article by Damien McCotter and Peter Wilcox. Originally published in Managing Intellectual Property’s World IP Contacts Handbook, 14th edition, 2007. Available at www.mondaq.com


8. IP Expert Advice: Tips on creating a lab notebook that contains ‘convincing evidence’, www.edn.com/ article/CA6445886.html?industryid=47048


9. Admissibility of Electronic in Interferences, Bruce H. Stoner Jr., Chief Administrative Patent Judge, www.uspto.gov/web/offices/com/sol/og/con/files/ cons119.htm


10. Private communication: Colin Sandercock (Perkins Coie LLP) September 2011


11. Te ABCs of Electronic Signatures, David Nettleton, Lab Manager Magazine, 9 September 2010: www.labmanager.com/articles_ pf.asp?ID=707


12. Te AnIML Programme: http://animl.sourceforge.net 34


13. Te Pistoia Alliance: www.pistoiaalliance.org 14. SiLA Consortium for Standardisation in Lab Automation: www.sila.coop


15. International Consortium for Innovation and Quality in Pharmaceutical Development: http://iqconsortium.com/index.htm


16. Institute for Laboratory Automation: www.institutelabauto.org


17. Rogers, E. M., Diffusion of Innovations, Te Free Press. New York


18. Crossing Te Chasm, G.A. Moore, Capstone Publishing


19. Bagozzi, R. P., Davis, F. D., & Warshaw, P. R. (1992) Development and test of a theory of technological learning and usage. Human Relations, 45 (7), 660-686.


Further reading and websites


Stafford, J. E. H., (1995) Advanced LIMS Technology: Case studies and business opportunities, Springer, Christensen, C. M., Te Innovator’s Dilemma, Harvard Business School Press Segalstad, S. H., (2008) International IT Regulations and Compliance: Quality Standards in the Pharmaceutical and Regulated Industries, Wiley- Blackwell, McDowall, R. D., (1987) Laboratory Information Management Systems, Sigma Press Laboratory Notebook Guidelines: BookFactory, LLC,


2302 S. Edwin C. Moses Blvd, Dayton, OH 45408. Available at www.bookfactory.com Mahaffey, R. R., (1990) LIMS: Applied Information Technology for the Laboratory, Van Nostrand Reinhold Nakagawa, A. S., (1994) LIMS: Implementation and Management, Royal Society of Chemistry Sellen, A. J., and Harper, R. H. R., (2003) Te Myth of the Paperless Office, Te MIT Press Franklin, C., (2003) Why Innovation Fails, Spiro Press Kanare, H. M., (1985) Writing the Laboratory Notebook, An American Chemical Society Publication


Industrial Lab Automation: www.industriallabautomation.com Te Institute for Laboratory Automation: www.institutelabauto.org Te Integrated Lab: www.theintegratedlab.com Te latest information, news and articles on LIMS: www.LIMSfinder.com Te independent, non-commercial LIMS user’s group: www.LIMSforum.com Te online encyclopaedia for Laboratory, Scientific and Health Informatics: www.LIMSwiki.org Free online training courses on LIMS: www.LIMSuniversity.com Scientific Computing World: www.scientific-computing.com


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