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2008 01 30 ELNs and Compliance


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Looking at the different legal and regulatory requirements that surround ELN projects

Looking at the different legal and regulatory requirements that surround ELN projects

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  • 1. ELNs and Compliance Simon Coles
  • 2. Copies of these slides 2
  • 3. ELNs and Compliance • Compliant with what? • Typical approaches • Common problems 3
  • 4. About Amphora • Started in ELNs in 1996 • Globally deployed, fully electronic ELN for Kodak • Grew from there... • Now work with large & small companies • Biotechs, Pharma, Chemicals 4
  • 5. Who we work with 5
  • 6. Industry 6
  • 7. What we do • Patent Evidence Creation & Preservation • Make lawyers happy • Which means you can make scientists happy 7
  • 8. What we do • Sometimes our stuff is used... • Standalone (e.g. CRT presentation) • In conjunction with other “ELN” products (e.g. Solvay, Array etc.) • With in house systems (e.g. J&J) 8
  • 9. “ELNs and Compliance” 9
  • 10. Compliant with what? • The world cares about what your company does and how you do it (Regulation) • You want to be able to prove what you did so you can get the credit for it (Patents) • You have some internal requirements for retention & use of scientific data 10
  • 11. What is an ELN? • Helpful to distinguish • The different functionality that is provided by ELN systems • The different data which is created in the Research Lab 11
  • 12. What’s in an ELN? “Broad” aspects Security, Collaboration, Patent Protection etc. Chemistry Biology etc. etc. 12
  • 13. What’s sloshing around? • Not all the “Stuff” on our hard disks is the same • Various levels of abstraction • Need to keep it for different periods • Different levels of importance 13
  • 14. Different types of stuff Programmes Projects Experiments Interpreted Data/Reports Analysed/Processed Data Raw Data 14
  • 15. Records Requirements Quality Material to be Scrutiny Timescale Format criteria preserved XML Internal Scientific data Internal use Little, if any Company defined De Facto standards requirements Experiment write up ad hoc Published Primarily Scientific Regulatory XML Regulatory regulations, with data Defined by regulations inspection De Facto standards comment Some write up ~ 10 years before first Case law Primarily Experiment PDF come under scrutiny Patents Federal Rules of write up Adversarial Paper Retain for 50 -100 evidence etc. Some data Microfilm years 15
  • 16. Regulatory Compliance • Regulatory authorities want you to work in a certain way and require proof that you did • They also want to be assured you’re creating the records that are needed to diagnose/trace/fix issues 16
  • 17. Regulators • Medical, e.g. FDA and other national counterparts • Environmental, e.g. EPA • Employment, Health, etc. 17
  • 18. Regulators • Generally the people who are performing a regulated activity are intimately away of their regulatory responsibilities • There will often be an individual or group within the organisation who are responsible for your relationship with the regulator 18
  • 19. ELNs in a Regulated area • The regulator is generally interested in what you did and how • It is impossible to split the record keeping layer and the activity 19
  • 20. Regulated areas “Broad” aspects o ut te into ra g Security, Collaboration, Patent Protection etc. pa pin er Se ee ay ’t K an rd L C o ra te ec Sepa etc. Chemistry R Biology etc. a 20
  • 21. Have to do this is ng p”, pi e ee De ity k “ rd he onal Chemistry eco Biologyt ti etc. etc. R t of unc ar ific f p c s pe 21
  • 22. Different types of stuff Care an awful lot about the lower Programmes levels Projects Experiments Interpreted Data/Reports Analysed/Processed Data Raw Data 22
  • 23. ELNs in a Regulated Area • “Generic” ELNs are rare in a regulated area • Often, the thing that replaces your Paper Notebook may not even be called an “ELN” 23
  • 24. Paper Notebook Replacements • SDMS • Compliance Management Systems • LIMS 24
  • 25. Keeping Lawyers Happy • In Discovery, at some point you’re going to have a clever idea • Your lawyers will want to patent it 25
  • 26. Patents and Records • You get a patent primarily for what happened in someone’s brain • Hopefully you have some record of that • Which you then take into court 26
  • 27. Patents and Records • Unfortunately a patent case is conducted in a court of law • This makes it somewhat of a blood sport • Your records have to survive adversarial scrutiny • Ideally you haven’t got anything hanging around which causes you a problem 27
  • 28. Keeping Lawyers Happy • Some kind of Patent Evidence Creation & Preservation Process/System • Will take records from all systems • Author Signed, and Witnessed • Long retention periods for the experiment writeups • Get rid of everything else 28
  • 29. Surviving Court • Designing Patent Evidence Systems is an interesting game • Lots little interdependencies • Technology is only a small part of it • In fact, the less technology the better! • All about simplicity and reliability 29
  • 30. Keeping Lawyers Happy “Broad” aspects st u n m io Security, Collaboration, Patent Protection etc. ly at te ar lu ep so s b is A th d o Chemistry Biology etc. etc. 30
  • 31. Different types of stuff Keep Experiment Get rid of this stuff as Writeups for a long soon as prudent Programmes time (assuming you don’t Projects need it for any other Experiments reason) Interpreted Data/Reports Analysed/Processed Data Raw Data 31
  • 32. 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! 32
  • 33. 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 33
  • 34. Interesting Thoughts • Scientists are happy and productive • You don’t spend all that much money (good ROI!) • Lawyers get a reliable process and good evidence 34
  • 35. Questions? 35
  • 36. Copies of these slides 36