2007 09 26 ELN Working Routine
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This document provides advice on selecting and implementing an electronic laboratory notebook (ELN). It discusses that the needs will vary depending on whether a company is regulated, the industry, and whether work is more chemistry or biology focused. For chemistry, a chemistry-centric ELN can be selected, while for biology the goal is to get the tool out of their way. Large chemical companies have diverse needs that may be difficult to fully understand. The document emphasizes understanding current workflows before selecting a tool and avoiding overcomplex security and records management systems.
2007 09 26 ELN Working Routine
- 1. ELN Working Routines John Trigg & Simon Coles
- 2. Introduction to Me • CTO & Co-founder of Amphora Research Systems • Working on ELNs since 1996 • A number of our customers are here & speaking
- 3. Why me? • We do the Patent Evidence problem • Keep the lawyers happy • You still need to make the scientists happy • So we get a ring-side seat on some of these problems
- 4. This Presentation • Adapted from an all-day workshop given every year at the Association for Lab Automation in Palm Springs • Come and join us in January! • Hot, Sunny, and informative...
- 5. So.... • You’ve decided to get an ELN • Do you • Buy a tool, and fit your work to the tool? • Find out how you work, and buy/build a tool to fit?
- 6. The “ELN” Word • Very ambiguous • Probably best if you didn’t use it • Say what you mean
- 7. What do you mean? • The term “ELN” means different things to different people • Somewhere the scientists will work • A Patent Evidence system (& long term record)
- 8. Patent Evidence • Typically this is a broad, thin layer • Consistently applied across the whole company
- 9. Differences that make a Difference • There are 2 key aspects which impact the character of your ELN implementation • Regulated Vs Unregulated • Industry
- 10. Regulated or not? • If you are regulated, chances you are talking about process automation, enforcement, and compliance • This isn’t easy, but it is • Relatively unambiguous • Fairly well mapped already
- 11. Industry/Company Type • Life Sciences • Biotech or Pharma • Biology Vs Chemistry • Multi-national Chemicals
- 12. Chemistry Vs Biology • In Life Sciences, the biggest distinction is between Chemists and Biologists
- 13. Chemistry • Chemistry is pretty structured • Buy (or build) them a Chemistry-centric ELN and let them get on with it • The selection process is detailed but at least the work relatively consistently
- 14. Sources of Chemistry ELNs • If you’re a big pharma, you’re probably already set • With varying success - this isn’t easy • Solutions • Buy off the shelf • Build from what you have • Vendor capture
- 15. Sources of Chemistry • In Biotechs, you probably can’t afford to build or do vendor capture • Unless Cheminformatics is a core strength • So you’re going to have do as much as you can with off-the-shelf (customised as needed) • Nice selection of vendors, have fun!
- 16. Biology • Massive diversity • Lots of Microsoft Office and other “non ELN” applications • Best approach is to get out of their way
- 17. Examples • Nadine’s talk about J&J earlier • Really good example of in-depth analysis of process • 98% approval rate on a project that size is pretty stunning
- 18. Large Chemicals • Somewhat boring places you may or may not have heard of • But employ 1,000 of scientists and make most of the fun stuff in your house and car • e.g. companies like Kodak, BASF, PPG, Milliken, USG, etc.
- 19. Large Chemicals • Massive diversity • R&D is typically very close to the customer • Tight timescales • Low tolerance for “non-value add” activities
- 20. Large Chemicals • The ELN project will “Open the can of worms” in terms of • The tools people are using • The records they are creating • The patent evidence that is generated
- 21. General Purpose ELNs • “You all use the same Paper notebook don’t you?” • “So surely you can all use the same Electronic notebook?”
- 22. General Purpose ELNs • You can do it for small numbers of users and certain styles of work (e.g. e2v) • Where workflow is important • For large numbers of users • The diversity in process will kill you • You end up building an expensive version of Word & Excel
- 23. General Purpose ELNs Functionality Number of users
- 24. General Purpose ELNs Functionality Possible Number of users
- 25. General Purpose ELNs Functionality Possible Possible Number of users
- 26. General Purpose ELNs Functionality Possible Doomed to fail The organisation will frustrate you Possible Number of users
- 27. Front end tools • Most organisations will end up providing different front ends to different users • Examples • BMS, Solvay, all the other large companies
- 28. Patents • As a rule, what you need to do from a Patent perspective is pretty generic • You might have some specific needs, but 95% of what you need can be done off the shelf • This is one area where you want to stick with convention
- 29. Security • In Life Sciences things are relatively sane • In Large Chemicals, you get all the fun of “Chinese Walls” created by Commercial agreements
- 30. Security • This is another whole can of worms • That didn’t really exist until the ELN came along • No one could find anything in the paper notebook anyway
- 31. Security • Ultimately you have to do what the organisation requires • But you need to avoid massively complex regimes • If you do NDA-related Chinese walls, you need to have that tagged into the record at creation
- 32. Records Management • The Cinderella of ELN projects • Desperately important • Clearly something that’s dependent on your own processes
- 33. Conclusions • Our original question • Some thoughts
- 34. Our Questions • Do you • Buy a tool, and fit your work to the tool? • Find out how you work, and buy/build a tool to fit?
- 35. Conclusion • Unless you have been specifically charged with changing the workflow • Don’t pick the fight • You’re there to support the science • Today and in the future
- 36. Conclusions • They’ve probably already got what they need anyway • Or a very good idea of what they need • That’s why they asked for an ELN in the first place
- 37. Conclusion • If you are charged with changing the workflow • That’s your project, not “ELN” or whatever • Try to keep the scope as small as possible • Size and diversity will kill you
- 38. Patent • Stick with best practice unless you really know what you are doing
- 39. Security • Do what you have to do • But try to keep it simple
- 40. Conclusion • Chemistry - buy, or build, the best you can • Biology - get out of their way • Large chemicals - you’ll never fully understand everything in detail