Biology ELN Compliance
8th Annual Pharma Technology &
IT Congress, 15th & 16th
September 2010, London
Joanna Mulgrew
Biolo...
Contents
• What is Compliance?
• Why do we need it?
• Measuring Compliance
• Ensuring Compliance
• Training and Support
• ...
What is compliance?
Noun (http://dictionary.reference.com)
1. The act of conforming, acquiescing, or yielding
2. a tendenc...
Why do we need it?
4
• Intellectual Property
–Capture the idea straight away
–How and when an experiment was
conducted
• B...
So what’s really different about an ELN ?
5
Research Biology conforms to
existing paper notebook guidelines,
but now in an...
Measuring Compliance
• What should we measure?
–Writing up the experiment
–Publishing to a versioned PDF and
storing in a ...
Measuring Compliance contd...
7
• IDBS E-WorkBook Suite (V 8.1.1)
• Query application database
–SQL query packaged as a Pi...
8
How do you check content?
•Standard write up and SOP templates
•Quick “Drag and drop” for routine stuff
•Use common synt...
Ensuring Compliance
9
• Biologists = Chemists!! Log in first
thing + write up everything in their
ELN
• ELN + signing work...
10
Ensuring Compliance contd...
• Design and support easy access to help
and training materials
• Engage a “Super User” in...
Ensuring compliance
• The power of “peer pressure”
• Clear policy on data and document storage
linked to ELN – mandatory t...
Enterprise tools – simple
12
• Videos
• OneNote Notebook
• SharePoint Site
• Wikis
• Drop in sessions
Use these to
supplem...
Training Sessions – different “flavours”
13
In House &
External Trainers
Introduction to E-Workbook
Wiki updates
Publishin...
Training Videos
14
• Used Camptasia/Jing
• No longer than 1.5minutes
–Split into small sections
• Can be really basic
–Mos...
Training videos
15
•created by
our IT intern
•linked via
internal wiki
OneNote
16
• Fully searchable
• Users leave feedback
• Training and support areas
• Community knowledge base
• Passed to C...
“Super Users”
17
• Key Users in each group
–On pilot
–Interface with end users
–Provide feedback and support
• OneNote Not...
SharePoint Main Site
Easy to navigate User friendly
18
SharePoint site
19
• End users/deployment team
• SP link in E-mail signature
• Hotdesk Calendar – key interactions –
quick...
• Document Storage
• Support and Training
–Post questions
–Useful Links
20
SharePoint site contd...
SharePoint
Enhancements and Requirements
• Share ideas with
Global Team
• Prioritised and
discussed with
vendor
• 90% of r...
SharePoint – Support, Top Tips and Q’s
• End Users check here to see if their issue is
listed and a fix provided
• Broken ...
View previous questions:
SharePoint – Questions
23
SharePoint – Useful Links
• Listed on main Sharepoint site
–Vendor information/webinars
–Training Materials
–Useful Sites
...
Internal Wiki - Pfizerpedia
25
• Global resource
• Easily searchable
• Link information and prevent replication
–Useful fo...
Summary
• Don’t assume “If you build it, they will
come......”
• Use diverse, accessible training and
support to engage th...
Enterprise.... We have a problem
27
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...
Acknowledgements
• Paul Driscoll
• Nuzrul Haque
• Damon Jellicoe
• Phil Laflin
• Jerry Lanfear
• Tim McLellan
• Natalie Pa...
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Oxford global conference sep 2010

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

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Oxford global conference sep 2010

  1. 1. Biology ELN Compliance 8th Annual Pharma Technology & IT Congress, 15th & 16th September 2010, London Joanna Mulgrew Biology Data Support, Materials & Data Management
  2. 2. Contents • What is Compliance? • Why do we need it? • Measuring Compliance • Ensuring Compliance • Training and Support • Summary 2
  3. 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. 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. 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. 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. 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. 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. 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. 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. 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. 12. Enterprise tools – simple 12 • Videos • OneNote Notebook • SharePoint Site • Wikis • Drop in sessions Use these to supplement “just in time” classroom sessions
  13. 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. 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. 15. Training videos 15 •created by our IT intern •linked via internal wiki
  16. 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. 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. 18. SharePoint Main Site Easy to navigate User friendly 18
  19. 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. 20. • Document Storage • Support and Training –Post questions –Useful Links 20 SharePoint site contd...
  21. 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. 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. 23. View previous questions: SharePoint – Questions 23
  24. 24. SharePoint – Useful Links • Listed on main Sharepoint site –Vendor information/webinars –Training Materials –Useful Sites 24
  25. 25. Internal Wiki - Pfizerpedia 25 • Global resource • Easily searchable • Link information and prevent replication –Useful for tracking –Catalogue of spreadsheet tools
  26. 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. 27. Enterprise.... We have a problem 27
  28. 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. 29. Acknowledgements • Paul Driscoll • Nuzrul Haque • Damon Jellicoe • Phil Laflin • Jerry Lanfear • Tim McLellan • Natalie Paziena 29

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