Biology ELN Compliance

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

Joanna Mulgrew

Biology Data Support, Materials & Data Management

Contents

• What is Compliance?

• Why do we need it?

• Measuring Compliance

• Ensuring Compliance

• Training and Support

• Summary

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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

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Why do we need it?

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• 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

So what’s really different about an ELN ?

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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 contentUnique Ids to link data across

systems

Erm....Not a lot

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

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Measuring Compliance contd...

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• 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

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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

Ensuring Compliance

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• 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

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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

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)

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Enterprise tools – simple

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• Videos• OneNote Notebook• SharePoint Site• Wikis• Drop in sessions

Use these to supplement “just in time” classroom sessions

Training Sessions – different “flavours”

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In House & External Trainers

Introduction to E-Workbook

Wiki updates

Publishing ProblemsUsing Templates

Spreadsheets

Interactive sessions

Group & 1-2-1

Training Videos

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• Used Camptasia/Jing• No longer than 1.5minutes

–Split into small sections• Can be really basic

–Most don’t even need a voice-over

Training videos

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•created by our IT intern •linked via internal wiki

OneNote

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• Fully searchable• Users leave feedback• Training and support areas• Community knowledge base• Passed to Central IT

Helpdesk - Reduced local support burden

“Super Users”

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• Key Users in each group–On pilot –Interface with end users–Provide feedback and support

• OneNote Notebook–Encourage use of errors/issue section

SharePoint Main Site

Easy to navigate User friendly

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SharePoint site

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• 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

• Document Storage• Support and Training

–Post questions–Useful Links

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SharePoint site contd...

SharePoint Enhancements and Requirements

• Share ideas with Global Team

• Prioritised and discussed with vendor

• 90% of requests were incorporated into product releases

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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

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View previous questions:

SharePoint – Questions

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SharePoint – Useful Links

• Listed on main Sharepoint site–Vendor information/webinars–Training Materials–Useful Sites

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Internal Wiki - Pfizerpedia

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• Global resource• Easily searchable • Link information and prevent replication

–Useful for tracking–Catalogue of spreadsheet tools

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

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Enterprise.... We have a problem

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And finally...The results

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1 2 3 4 5 6 7 8 9 10 11 120

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0%

10%

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30%

40%

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80%

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100%Experiments Saved and Signed

Experiments Saved% Submitted% Signed

Acknowledgements

• Paul Driscoll• Nuzrul Haque• Damon Jellicoe• Phil Laflin• Jerry Lanfear• Tim McLellan• Natalie Paziena

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