2009 04 21 Lessons Learned Eln Implementations
 

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2009 04 21 Lessons Learned Eln Implementations

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Discusses the issues of Records Management and Patent Evidence in Laboratories, with particular emphasis on Electronic Lab Notebooks. ...

Discusses the issues of Records Management and Patent Evidence in Laboratories, with particular emphasis on Electronic Lab Notebooks.

Delivered at IQPC Data Management & Knowledge Discovery. 21st April 1009, Frankfurt, Germany.

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  • Instruments, MS Office, In house tools, ELNs from many different vendors <br />
  • Instruments, MS Office, In house tools, ELNs from many different vendors <br />
  • Instruments, MS Office, In house tools, ELNs from many different vendors <br />
  • Instruments, MS Office, In house tools, ELNs from many different vendors <br />
  • Instruments, MS Office, In house tools, ELNs from many different vendors <br />
  • Instruments, MS Office, In house tools, ELNs from many different vendors <br />
  • Instruments, MS Office, In house tools, ELNs from many different vendors <br />
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  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
  • This is just a sample <br /> 50/50 split between Europe and North America <br />
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  • Science is huge <br /> Complex before you even get into the IT <br />
  • Different departments, ways of working <br /> Then the IP layer <br /> As much as you can... just as you do with the notebook <br />
  • Different departments, ways of working <br /> Then the IP layer <br /> As much as you can... just as you do with the notebook <br />
  • Different departments, ways of working <br /> Then the IP layer <br /> As much as you can... just as you do with the notebook <br />
  • Different departments, ways of working <br /> Then the IP layer <br /> As much as you can... just as you do with the notebook <br />
  • Different departments, ways of working <br /> Then the IP layer <br /> As much as you can... just as you do with the notebook <br />
  • Different departments, ways of working <br /> Then the IP layer <br /> As much as you can... just as you do with the notebook <br />
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  • The lower levels are very specific to the area <br />
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2009 04 21 Lessons Learned Eln Implementations Presentation Transcript

  • 1. Lessons from the Edge (think now, or pay later) Simon Coles CTO http://www.amphora-research.com/ 1
  • 2. A copy of this presentation can be downloaded from our web site http://www.amphora-research.com/ 2
  • 3. A copy of this presentation can be downloaded from our web site http://www.amphora-research.com/ 2
  • 4. Lessons from the Edge • What we do • How we work • What we’ve learned • Takeaway lessons http://www.amphora-research.com/ 3
  • 5. What we do • We allow scientists to concentrate on science • Using the tools they need to get the job done • Without worrying about IP concerns http://www.amphora-research.com/ 4
  • 6. Scientists use a variety of tools http://www.amphora-research.com/ 5
  • 7. Scientists use a variety of tools http://www.amphora-research.com/ 5
  • 8. Scientists use a variety of tools http://www.amphora-research.com/ 5
  • 9. Scientists use a variety of tools http://www.amphora-research.com/ 5
  • 10. Scientists use a variety of tools http://www.amphora-research.com/ 5
  • 11. Scientists use a variety of tools http://www.amphora-research.com/ 5
  • 12. Scientists use a variety of tools e c n ie c S http://www.amphora-research.com/ 5
  • 13. Scientists use a variety of tools e r u t e p c a n ie C c IP S http://www.amphora-research.com/ 5
  • 14. Example Scenarios http://www.amphora-research.com/ 6
  • 15. Example Scenarios • Typical Biotech – Chemistry-centric ELN for Chemists, Microsoft Office (esp. Excel) etc. for Biology http://www.amphora-research.com/ 6
  • 16. Example Scenarios • Typical Biotech – Chemistry-centric ELN for Chemists, Microsoft Office (esp. Excel) etc. for Biology • Pharma – 3 commercial ELNs, 2 in-house, Microsoft Office http://www.amphora-research.com/ 6
  • 17. Example Scenarios • Typical Biotech – Chemistry-centric ELN for Chemists, Microsoft Office (esp. Excel) etc. for Biology • Pharma – 3 commercial ELNs, 2 in-house, Microsoft Office • Chemicals – Whole variety of tools http://www.amphora-research.com/ 6
  • 18. Example Scenarios • Typical Biotech – Chemistry-centric ELN for Chemists, Microsoft Office (esp. Excel) etc. for Biology • Pharma – 3 commercial ELNs, 2 in-house, Microsoft Office • Chemicals – Whole variety of tools • Universities & quasi-academic – a bit of a zoo! http://www.amphora-research.com/ 6
  • 19. Some people we work with http://www.amphora-research.com/
  • 20. Some people we work with http://www.amphora-research.com/
  • 21. How we do it http://www.amphora-research.com/ 8
  • 22. How we do it • A product - PatentSafe® •Simplest, safest, easiest replacement for the Paper Notebook (we hope! :-) http://www.amphora-research.com/ 8
  • 23. How we do it • A product - PatentSafe® •Simplest, safest, easiest replacement for the Paper Notebook (we hope! :-) • An implementation approach •Pilot – does this work for the scientists? •Fire Drill – does the system create good evidence? http://www.amphora-research.com/ 8
  • 24. How we do it • A product - PatentSafe® •Simplest, safest, easiest replacement for the Paper Notebook (we hope! :-) • An implementation approach •Pilot – does this work for the scientists? •Fire Drill – does the system create good evidence? http://www.amphora-research.com/ 8
  • 25. How we do it • A product - PatentSafe® •Simplest, safest, easiest replacement for the Paper Notebook (we hope! :-) • An implementation approach •Pilot – does this work for the scientists? •Fire Drill – does the system create good evidence? (System = People + Process + Software) http://www.amphora-research.com/ 8
  • 26. The Fire Drill • This presentation is basically comprised of lessons from the Fire Drill exercise we run • After a few weeks, all the participants get in a room and “War game” taking a record from PatentSafe into Court • Often the first time all participants have a 360° view of the process • Excellent communication & discovery exercise http://www.amphora-research.com/ 9
  • 27. Fire Drill outcomes http://www.amphora-research.com/ 10
  • 28. Fire Drill outcomes • Scientists often had no idea what would happen • Radically change how they write things up http://www.amphora-research.com/ 10
  • 29. Fire Drill outcomes • Scientists often had no idea what would happen • Radically change how they write things up • IT had no idea what happens when a bunch of lawyers start asking questions http://www.amphora-research.com/ 10
  • 30. Fire Drill outcomes • Scientists often had no idea what would happen • Radically change how they write things up • IT had no idea what happens when a bunch of lawyers start asking questions • Lawyers get a bigger picture of the scientists world http://www.amphora-research.com/ 10
  • 31. Fire Drill outcomes • Scientists often had no idea what would happen • Radically change how they write things up • IT had no idea what happens when a bunch of lawyers start asking questions • Lawyers get a bigger picture of the scientists world • Everyone (and their bosses!) now understands the fuller picture http://www.amphora-research.com/ 10
  • 32. Lessons Learned • That “ELN” word • User-focused • IT Architecture • Records Management http://www.amphora-research.com/ 11
  • 33. “ELN” http://www.amphora-research.com/ 12
  • 34. “ELN” • “Electronic Laboratory Notebook” is more of a marketing term than anything else • Designed to separate you from your money • It isn’t that useful when describing systems http://www.amphora-research.com/ 12
  • 35. “ELN” • “Electronic Laboratory Notebook” is more of a marketing term than anything else • Designed to separate you from your money • It isn’t that useful when describing systems • Say what you mean • Somewhere for scientists to work • Somewhere to create & preserve evidence http://www.amphora-research.com/ 12
  • 36. Being clear helps • Helps you understand requirements • Helps you understand target audience internally • Helps you understand who pays for it • Helps you understand how you’re going to run it http://www.amphora-research.com/ 13
  • 37. Users • Scientists are a varied and challenging user base • Treated right they will really help you • But you need to approach with care • Ultimately, a good ELN will revolutionalise your Scientist’s world http://www.amphora-research.com/ 14
  • 38. Diversity needs dealing with • Many projects get stuck on the sheer complexity of the scientific process • Especially in larger firms • With many different spheres of activity • Two frameworks which might help • Look at the diversity of activity and where to put your attention • Tease out what data is important and what isn’t http://www.amphora-research.com/ 15
  • 39. Dealing with Diversity http://www.amphora-research.com/ 16
  • 40. Medicinal Chemistry http://www.amphora-research.com/ Process Chemistry Molecular Biology Pharmacology 16 Etc. Dealing with Diversity
  • 41. Dealing with Diversity Corporate aspects (Records, IP protection, Sharing) Medicinal Chemistry Process Chemistry Molecular Biology Pharmacology Etc. http://www.amphora-research.com/ 16
  • 42. Dealing with Diversity Corporate aspects (Records, IP protection, Sharing) Medicinal Chemistry Process Chemistry Molecular Biology Let them use Pharmacology whatever systems they want here Etc. (because they will anyway) http://www.amphora-research.com/ 16
  • 43. Dealing with Diversity Corporate aspects Focus IP concerns here (Records, IP protection, Sharing) Medicinal Chemistry Process Chemistry Molecular Biology Let them use Pharmacology whatever systems they want here Etc. (because they will anyway) http://www.amphora-research.com/ 16
  • 44. Dealing with Diversity Corporate aspects Focus IP concerns here (Records, IP protection, Sharing) Medicinal Chemistry Process Chemistry Molecular Biology Pharmacology s Let them use o whatever systems ha they want here C Etc. (because they will ive anyway) at re C http://www.amphora-research.com/ 16
  • 45. Dealing with Diversity y s, nc es te oc Corporate aspects sis , Pr Focus IP concerns on e C lin here (Records, IP protection, Sharing) ip isc D Medicinal Chemistry Process Chemistry Molecular Biology Pharmacology s Let them use o whatever systems ha they want here C Etc. (because they will ive anyway) at re C http://www.amphora-research.com/ 16
  • 46. Don’t be tempted • Don’t be tempted to mix where the scientists work, and the record keeping system • We tried that with the paper notebook and that didn’t work out well for anyone • Creates lots of issues for introduction & ownership • Also, don’t mix systems for IP protection and Regulatory Compliance • Different problems • Very hard (impossible?) to do in one place http://www.amphora-research.com/ 17
  • 47. What’s Important • Most scientific activity creates electronic “Stuff” • Some of this is more useful than others • Programmes Useful to look at things as a pyramid Projects Experiments Interpreted Data/Reports Raw Data http://www.amphora-research.com/ 18
  • 48. What’s Important • Most scientific activity creates electronic “Stuff” • Some of this is more useful than others • Programmes Useful to look at things as a pyramid Projects Experiments Not so interesting, Long Term Interpreted Data/Reports Harder to preserve anyway Raw Data http://www.amphora-research.com/ 18
  • 49. What goes in the notebook Programmes Projects Corporate aspects Experiments (Records, IP protection, Sharing) Process Chemistry Interpreted Data/Reports Molecular Biology Pharmacology Chemistry Medicinal Raw Data Etc. http://www.amphora-research.com/ 19
  • 50. What goes in the notebook? • Nothing need change from the paper notebook process • Just because you can dump loads of raw data in, doesn’t mean you need to • Scientists will often need specific guidance on what to put in for different circumstances • Often what’s currently happening isn’t what you need • One advantage of an electronic system is you can sample what they’re doing and offer gentle assistance http://www.amphora-research.com/ 20
  • 51. Don’t torture them • Be careful about requiring a particular workstyle or front end tool • You won’t change their behaviors • Just that anything that falls outside what you view as correct working won’t be protected • Be careful about requiring lots of extra work • Their good intentions won’t survive a busy period • Then you’ve got inconsistent practices http://www.amphora-research.com/ 21
  • 52. Notebook Practices • How people keep notebooks • What they put in them • The other stuff they keep • The impact of moving to Electronic Systems http://www.amphora-research.com/ 22
  • 53. People aren’t keeping notebooks properly http://www.amphora-research.com/ 23
  • 54. People aren’t keeping notebooks properly • Typically in most larger organistions • 20% of the people who are laboriously creating notebooks (fully witnessed) don’t need to because their work isn’t IP sensitive • A fair number of the most prolific inventors aren’t keeping notebooks at all and there’s very little evidence of their work http://www.amphora-research.com/ 23
  • 55. People aren’t keeping notebooks properly • Typically in most larger organistions • 20% of the people who are laboriously creating notebooks (fully witnessed) don’t need to because their work isn’t IP sensitive • A fair number of the most prolific inventors aren’t keeping notebooks at all and there’s very little evidence of their work • Most companies have a very low compliance with their paper process for signing & witnessing http://www.amphora-research.com/ 23
  • 56. They’re writing the wrong stuff down • Often very difficult for scientists to know what they should be writing up • Some think all that matters is data, when we really care about what was going on in their brains • Need simple guidance which can be applied in a variety of situations http://www.amphora-research.com/ 24
  • 57. They keep too much stuff http://www.amphora-research.com/ 25
  • 58. They keep too much stuff • Most scientists view any data as valuable http://www.amphora-research.com/ 25
  • 59. They keep too much stuff • Most scientists view any data as valuable • So they keep everything • Generally anywhere • With little indexing http://www.amphora-research.com/ 25
  • 60. They keep too much stuff • Most scientists view any data as valuable • So they keep everything • Generally anywhere • With little indexing • A nightmare when it comes to legal discovery http://www.amphora-research.com/ 25
  • 61. They keep too much stuff • Most scientists view any data as valuable • So they keep everything • Generally anywhere • With little indexing • A nightmare when it comes to legal discovery • Your Records Manager is your best friend • A well thought and consistent Records Management process is your best asset http://www.amphora-research.com/ 25
  • 62. They keep too much stuff • Most scientists view any data as valuable • So they keep everything • Generally anywhere • With little indexing • A nightmare when it comes to legal discovery • Your Records Manager is your best friend • A well thought and consistent Records Management process is your best asset • This isn’t really a Notebook problem – but it is your problem http://www.amphora-research.com/ 25
  • 63. SOPs • Fairly simple • Write down what you are planning to do • Do it • Avoid the temptation to be overly ornate or prescriptive • An ELN SOP is generally shorter than the paper one it replaces http://www.amphora-research.com/ 26
  • 64. Site Vs Global http://www.amphora-research.com/ 27
  • 65. Site Vs Global • Most multi-site organisations have site- specific Paper Notebook SOPs • Merger/acquisition • Historic working practices (& legal considerations) • Work style http://www.amphora-research.com/ 27
  • 66. Site Vs Global • Most multi-site organisations have site- specific Paper Notebook SOPs • Merger/acquisition • Historic working practices (& legal considerations) • Work style • Most ELNs are rolled out globally http://www.amphora-research.com/ 27
  • 67. Site Vs Global • Most multi-site organisations have site- specific Paper Notebook SOPs • Merger/acquisition • Historic working practices (& legal considerations) • Work style • Most ELNs are rolled out globally • You will hit these issues in the Fire Drill! http://www.amphora-research.com/ 27
  • 68. Some good news http://www.amphora-research.com/ 28
  • 69. Some good news • A properly designed ELN/Patent Evidence system will give you better more reliable records than the existing paper system • And save an awful lot of scientist time! http://www.amphora-research.com/ 28
  • 70. Some good news • A properly designed ELN/Patent Evidence system will give you better more reliable records than the existing paper system • And save an awful lot of scientist time! • With an electronic system you get a much better idea of what’s really going on http://www.amphora-research.com/ 28
  • 71. Some good news • A properly designed ELN/Patent Evidence system will give you better more reliable records than the existing paper system • And save an awful lot of scientist time! • With an electronic system you get a much better idea of what’s really going on • You will get very high levels of compliance with your requirements • For example documents tend to be witnessed in less than an hour compared to weeks http://www.amphora-research.com/ 28
  • 72. IT Architecture • Overall Architecture • System Design • Dealing with your organisation http://www.amphora-research.com/ 29
  • 73. Split the Systems • Keeps the lawyers out of the scientist’s tools • Can build/buy the science-facing ELNs as needed, and manage as appropriate • The Patent Evidence system can be unperturbed http://www.amphora-research.com/ 30
  • 74. Evidence Systems • For this problem, dependancies bring complication risk and little reward • They can only help with a few small areas, which should be easy to do internally • Generally on balance of risks, it isn’t worth it http://www.amphora-research.com/ 31
  • 75. Reduce Dependancies • You really want everything under your control • Makes it easier to run the system • Makes it easier to defend the system • Makes sure everyone pays attention http://www.amphora-research.com/ 32
  • 76. Reduce Dependancies • This applies to internal infrastructure as much as it does to external parties • Your infrastructure team might not be prepared for a legal invasion http://www.amphora-research.com/ 33
  • 77. Your Organisation is Stupid http://www.amphora-research.com/ 34
  • 78. Your Organisation is Stupid • I don’t worry about the integrity of things in the short term http://www.amphora-research.com/ 34
  • 79. Your Organisation is Stupid • I don’t worry about the integrity of things in the short term • I do worry about 10, 20, 30 years in the future • Murphy’s law hasn’t been repealed • Simplicity and accountability is key http://www.amphora-research.com/ 34
  • 80. Your Organisation is Stupid • I don’t worry about the integrity of things in the short term • I do worry about 10, 20, 30 years in the future • Murphy’s law hasn’t been repealed • Simplicity and accountability is key • Most IT organisations aren’t setup for this http://www.amphora-research.com/ 34
  • 81. Records Management • Your Unsung Heroes • Can finally manage Electronic Records in R&D http://www.amphora-research.com/ 35
  • 82. Unsung Heroes • Nobody really pays attention to Records Management until things go wrong • In fact, they’ve got a lot of really useful things to say, even without legal issues • The ELN Project often puts Records Management on the agenda in a wider sense http://www.amphora-research.com/ 36
  • 83. Pay attention to what you’re creating • Not just about experimental write ups • More data isn’t necessarily better • We spend a lot of time making sure we don’t store “unhelpful” things http://www.amphora-research.com/ 37
  • 84. Pay Attention to how you keep it • Records retention rules are key • You shouldn’t be planning to keep everything forever • You can’t • You don’t want to • Evidence system will have long retention period • Working systems might have a lower retention perion http://www.amphora-research.com/ 38
  • 85. IT & Records Management • Make sure you nominate a Custodian of every IP- critical system you have, at the outset • Most IT tools have well-meaning features which are really nasty from a records perspective • e.g. regulatory systems which create masses of unhelpful detailed data with no way of purging it • Few IT tools are built with long term records involved • It really isn’t in the vendor’s interest to worry http://www.amphora-research.com/ 39
  • 86. System Ownership • What do you optimise for: • Happy, productive scientists? • Good, strict, reliable records? • Splitting out the science systems into separate systems, with a separate record keeping layer makes things a lot easier http://www.amphora-research.com/ 40
  • 87. Interesting Thoughts • A lot of people in Discovery aren’t keeping the right stuff in their notebooks • Sometimes too detailed, sometimes not enough • Sometimes the people keeping the best notebooks don’t need to keep them • Sometimes the people who should aren’t! http://www.amphora-research.com/ 41
  • 88. Interesting Thoughts • The lawyers don’t want to torture you • Really, honestly • You can create good patent evidence reasonably painlessly • Decent front-end system • Good backend http://www.amphora-research.com/ 42
  • 89. End Result of Electronic Evidence Systems • Scientists are happy and productive • You don’t spend all that much money (good ROI!) • Lawyers get a reliable process and good evidence • It costs less • It lasts longer http://www.amphora-research.com/ 43
  • 90. Takeaways • If you’re looking for a new career, Records Management is hot • If you’re introducing a new system, make Records Management part of the system design & introduction http://www.amphora-research.com/ 44
  • 91. Takeaways • Electronic Systems can make everyone happy • Splitting out records keeping & patent evidence makes things a lot easier http://www.amphora-research.com/ 45