Summary Building a Smart Laboratory 2017

consequences of increased automation, in making some laboratory work less attractive. Snowden’s argument is that the success

of process techniques in one domain raises the temptation to apply them in other domains to which they may not be suited. So, for example, in the ‘social complexity’ domain, where free- thinking and creativity are important qualities, rigid and systematic processes may prove to be a constraint. Te other two domains, ‘mathematical

complexity’ and ‘systems dynamics’ both have an intellectual component, but contain sub- processes that may lend themselves to engineered interventions. Te overall conclusion is that different management styles, processes, and systems are required for each of the four domains, and that it doesn’t follow that what works in one domain will necessarily work in another. Tis way of looking at things may shed some

light on why the early ELN market was sub- divided into different solutions for chemistry, biology and QA. Te risk for a multi-disciplinary laboratory that is looking to implement an ELN would be to adopt a one-size-fits-all approach. Tis could generate disaffection amongst users. Te current informatics market is moving

towards more modular solutions, which have a generic core, and optional discipline-specific modules. Tis creates a better opportunity to find a single-source solution. Te shared functions can be separated from the scientific functions which are closer to the heart and soul of the scientist’s laboratory work. Shared functions would include such issues as document authoring, approval/ witnessing, file and document management, and legal and regulatory compliance -- all of which fall into the ‘bureaucratic’ category and which lend themselves to process improvement opportunities more readily than the scientific aspects. It may still be a one-size-fits-all approach, but it can be designed to accommodate the requirements of multi-disciplinary laboratories, and to standardise and improve common sub-processes, rather than making compromises. Ideally, laboratory informatics tools should

not be perceived as an intrusive bureaucratic process, but rather as something that facilitates the scientific method and doesn’t intrude on the social and intellectual processes that are essential to the science. Achieving this objective is essential to joined-up science and to user acceptance, and is a responsibility that falls to management in its objective of building a smart laboratory. It requires a sympathetic view of the requirements of the

different disciplines, and the way in which these functions are managed and provided for, even when organisational demands push for increased uniformity and consistency. 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 stand-alone 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. Te focus of this guide has been on technology,

with due consideration to the laboratory processes to which it can be applied. It has also touched on some aspects of culture and technology adoption, but it must be remembered that user acceptance is a critical success factor in almost every system or project. Technology on its own cannot do it. Te take-home message is that to become ‘smart’ the laboratory needs to understand its role in the organisation’s end-to-end business processes and optimise its technologies to fulfil those requirements. n

References and further reading References

1. Te Gartner Hype Cycles: 2. CENSA: Te Collaborative Electronic Notebook Systems Association

3. Good Manufacturing Practice (GMP): Te US has one set in the Federal Register 21 CFR, and the EU has its own, as do other geographical areas and organisations like the Organisation for Economic Co-operation and Development (OECD) US FDA, 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals, 2005, FDA: European Union Volume 4: Good Manufacturing Practices – Medicinal products for human and veterinary use, 1998, 153 pages, incl. Annex 11 covering computerised systems

4. Good Laboratory Practice (GLP): Te US has one set in the Federal Register 21 CFR; EU has its own, and also other geographical areas US FDA, 21 CFR Part 58 Good Laboratory Practice for Non- Clinical Laboratory Studies, 2005, FDA: European Union, Council Directive of 7 June 1988 on the inspection and verification of Good Laboratory Practice (GLP) (88/320/EEC) European Union, Council Directive – of 24 November 1986 - 86/609/EEC – on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes

5. US FDA, 21 CFR Part 11 Electronic records; electronic signatures, 1997, FDA: OECD Series on principles of good laboratory practice and compliance monitoring number 10

6. European Union Volume 4: Good Manufacturing Practices – Medicinal products for human and veterinary use, 1998, 153 pages, incl. Annex 11 covering computerised systems

7. PIC/S, PI 011-03 Good practices for computerised systems in regulated ‘GxP’ environments. 25 September 2007, PIC/S:

8. GAMP 5 (Good Automated Manufacturing Practice) Guide: 42

A Risk-Based Approach to Compliant GxP Computerized Systems, February 2008, International Society for Pharmaceutical Engineering (ISPE), Fiſth Edition, ISBN 1-931879-61-3:

9. Good Automated Manufacturing Practice Guidelines version 5, International Society for Pharmaceutical Engineering, Tampa FL, 2008 McDowall, R.D., (2009) Spectroscopy Focus on Quality, p23

10. 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

11. IP Expert Advice: Tips on creating a lab notebook that contains ‘convincing evidence’: html?industryid=47048

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

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

14. Te ABCs of Electronic Signatures, Nettleton, D., Lab Manager Magazine, 9 September 2010: view/articleNo/3800/title/Te-ABCs-of-Electronic-Signatures

15. Rogers, E. M., Diffusion of Innovations, Te Free Press. New York 16. Moore, G. A., Crossing Te Chasm, Capstone Publishing 17. Bagozzi, R. P., Davis, F. D., and Warshaw, P. R., (1992). Development and test of a theory of technological learning and usage. Human Relations, 45(7), 660-686

18. Multi-Ontology Sense Making, David Snowden, http:// makingv2_May05.pdf

Further reading and websites

Stafford, J. E. H., (1995) Advanced LIMS Technology: Case studies and business opportunities, Springer Christensen, C. M., (1997) Te Innovator’s Dilemma: When New Technologies Cause Great Firms to Fail, 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 Mahaffey, R. R., (1990) LIMS: Applied Information Technology for the Laboratory, Nakagaw 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 Publiation

eOrganizedWorld: Free online LIMS training courses:

Te Generally Accepted Recordkeeping Principles:

Independent, non-commercial LIMS user’s group: Industrial Lab Automation: Te Institute for Laboratory Automation: Te Integrated Lab:

Journal of Information & Knowledge Management (JIKM): LIMSfinder: NL42 Consulting:

Online encyclopaedia for laboratory, scientific and health informatics: PDF/A standard: Scientific Computing World: Segalstad Consulting:

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