References

1. The Gartner Hype Cycles: www.gartner.com

2. CENSA: The Collaborative Electronic Notebook Systems Association

3. Good Manufacturing Practice (GMP): The 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: www.fda.gov

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): The 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: www.fda.gov

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: www.fda.gov

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: www.picsscheme.org

8. GAMP 5 (Good Automated Manufacturing Practice) Guide: A Risk-Based Approach to Compliant GxP Computerized Systems, February 2008, International Society for Pharmaceutical Engineering (ISPE), Fifth Edition, ISBN 1-931879-61-3: www.ispe.org

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 www.mondaq.com

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

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

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

14. The ABCs of Electronic Signatures, Nettleton, D., Lab Manager Magazine, 9 September 2010: www.labmanager.com/?articles.view/articleNo/3800/title/The-ABCs-of-Elec…

15. Rogers, E. M., Diffusion of Innovations, The Free Press. New York

16. Moore, G. A., Crossing The 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://cognitive-edge.com/uploads/articles/40_Multi-ontology_sense_maki…

References

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