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Oxford global conference sep 2010

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8th Annual Pharma Technology & IT Congress, 15th & 16th September 2010, London

8th Annual Pharma Technology & IT Congress, 15th & 16th September 2010, London

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  • 1. Biology ELN Compliance 8th Annual Pharma Technology & IT Congress, 15th & 16th September 2010, London Joanna Mulgrew Biology Data Support, Materials & Data Management
  • 2. Contents • What is Compliance? • Why do we need it? • Measuring Compliance • Ensuring Compliance • Training and Support • Summary 2
  • 3. What is compliance? Noun (http://dictionary.reference.com) 1. The act of conforming, acquiescing, or yielding 2. a tendency to yield readily to others, esp. in a weak and subservient way 3. conformity; accordance: in compliance with orders 4. cooperation or obedience: Compliance with the law is expected of all To have compliance you have to have an ELN policy..... and use it 3
  • 4. Why do we need it? 4 • Intellectual Property –Capture the idea straight away –How and when an experiment was conducted • Business continuity –Colleague or project transitions –Much easier with good compliance
  • 5. So what’s really different about an ELN ? 5 Research Biology conforms to existing paper notebook guidelines, but now in an ELN it is much easier to check this.... May even be easier for the users !!! Using write up templates with required content Unique Ids to link data across systems Erm.... Not a lot
  • 6. Measuring Compliance • What should we measure? –Writing up the experiment –Publishing to a versioned PDF and storing in a secure digital archive –Dates when experiment was run/recorded/published and fully signed off 6
  • 7. Measuring Compliance contd... 7 • IDBS E-WorkBook Suite (V 8.1.1) • Query application database –SQL query packaged as a PipeLine Pilot Web Port protocol (Accelrys) - a simple end-user tool
  • 8. 8 How do you check content? •Standard write up and SOP templates •Quick “Drag and drop” for routine stuff •Use common syntax across ELN •Experiment witness to “police” •Supervisor “spot checks” - cf “paper” ELN world
  • 9. Ensuring Compliance 9 • Biologists = Chemists!! Log in first thing + write up everything in their ELN • ELN + signing working well before trying to enforce compliance ... • Gain user “buy in” by highlighting importance of compliance
  • 10. 10 Ensuring Compliance contd... • Design and support easy access to help and training materials • Engage a “Super User” in each area • Regular Support drop in sessions – F2F does matter
  • 11. Ensuring compliance • The power of “peer pressure” • Clear policy on data and document storage linked to ELN – mandatory training • Be inventive with what/how you publish from the ELN (SOPs, links to other data) 11
  • 12. Enterprise tools – simple 12 • Videos • OneNote Notebook • SharePoint Site • Wikis • Drop in sessions Use these to supplement “just in time” classroom sessions
  • 13. Training Sessions – different “flavours” 13 In House & External Trainers Introduction to E-Workbook Wiki updates Publishing ProblemsUsing Templates Spreadsheets Interactive sessions Group & 1-2-1
  • 14. Training Videos 14 • Used Camptasia/Jing • No longer than 1.5minutes –Split into small sections • Can be really basic –Most don’t even need a voice-over
  • 15. Training videos 15 •created by our IT intern •linked via internal wiki
  • 16. OneNote 16 • Fully searchable • Users leave feedback • Training and support areas • Community knowledge base • Passed to Central IT Helpdesk - Reduced local support burden
  • 17. “Super Users” 17 • Key Users in each group –On pilot –Interface with end users –Provide feedback and support • OneNote Notebook –Encourage use of errors/issue section
  • 18. SharePoint Main Site Easy to navigate User friendly 18
  • 19. SharePoint site 19 • End users/deployment team • SP link in E-mail signature • Hotdesk Calendar – key interactions – quick hands-on fixes or pass to HelpDesk • Capture requirements, enhancements and feedback
  • 20. • Document Storage • Support and Training –Post questions –Useful Links 20 SharePoint site contd...
  • 21. SharePoint Enhancements and Requirements • Share ideas with Global Team • Prioritised and discussed with vendor • 90% of requests were incorporated into product releases 21
  • 22. SharePoint – Support, Top Tips and Q’s • End Users check here to see if their issue is listed and a fix provided • Broken into simple Categories 22
  • 23. View previous questions: SharePoint – Questions 23
  • 24. SharePoint – Useful Links • Listed on main Sharepoint site –Vendor information/webinars –Training Materials –Useful Sites 24
  • 25. Internal Wiki - Pfizerpedia 25 • Global resource • Easily searchable • Link information and prevent replication –Useful for tracking –Catalogue of spreadsheet tools
  • 26. Summary • Don’t assume “If you build it, they will come......” • Use diverse, accessible training and support to engage the users – Enterprise tools !! • Use of the ELN is compulsory, but building the support community gains user buy-in – and therefore compliance 26
  • 27. Enterprise.... We have a problem 27
  • 28. And finally...The results 28 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 0 500 1000 1500 2000 2500 3000 3500 1 2 3 4 5 6 7 8 9 10 11 12 Experiments Saved and Signed Experiments Saved % Submitted % Signed
  • 29. Acknowledgements • Paul Driscoll • Nuzrul Haque • Damon Jellicoe • Phil Laflin • Jerry Lanfear • Tim McLellan • Natalie Paziena 29

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