Starting From Scratch - the ELN Reality

Starting From Scratch: The ELN Reality John Trigg phaseFour Informatics Limited www.phasefour-informatics.com

Starting From Scratch: The ELN Reality
The advantages of going electronic and implementing an ELN system
The importance of integrating this with other informatics solutions
Is the “paperless lab” a truly attainable goal?

Paperless?
What do you mean by paperless?
No more paper?
or
Paper is not the archive medium?
Going paperless - the question is when, not if.

The advantages of going electronic and implementing an ELN system
Improved productivity
Greater efficiency
Improved information/knowledge management
Better IP protection
Better patent evidence creation
Happier scientists?

Who cares about Lab Notebooks? Lawyer Compliance Manager Lab Manager Finance Manager IP/Records Manager Scientist “ What exactly is an ELN and how will it help me? ” “ Will a court accept electronic records as evidence? ” “ Will an ELN comply with regulatory guidelines? ” “ How much is this going to cost, and what ’ s the ROI? ” “ Will we still be able to access our records in 50 years time? ” “ You want me to write-up my experiments where???? ”

The Case for an ELN
The Benefits
Easier to share
Accessible knowledge repository
Improved R&D productivity
By eliminating some mindless paper-based processes
Re-use of information
The Costs
Evaluation & Decision Making
Development
Configuration
Implementation
Training
Hardware
Software
Maintenance
Everything is based around one fundamental question: What is the problem you are trying to solve?
The Barriers
Functionality
Legal/Patent/Regulatory considerations
Electronic records management
Long term data preservation
User adoption
Costs

The Benefits – from case studies
Organisations that have implemented an ELN claim to be making time savings in the order of 10 - 15%.
Improvement in operational efficiency ~20%
Improvements in personal productivity
Anecdotal evidence points to additional, non-quantifiable benefits.
More time in the lab
Easier write-ups
Improved IP protection
Searchable archive
Increased efficiency
Improved data quality
Smooth transition when people leave the Company
Use in informal meetings

The Barriers
Addressing the required functionality (what is the problem you are trying to solve?)
Legal/Patent/Regulatory considerations
Long term data preservation
Electronic records management
User adoption
Costs

What is an Electronic Lab Notebook?
Scientific Requirements
Scientific Data Management
Discipline-specific systems
Experimental design
Laboratory Automation
LIMS
Documentation of Experiments
Electronic Record Keeping
Patent Evidence Creation
Evidence of Regulatory Compliance
Document Management
Definition of an ELN (CENSA*) “ A system to create, store, retrieve, and share fully electronic records in ways that meet all legal, regulatory, technical and scientific requirements. ” * Collaborative Electronic Notebook Systems Association Definition of an ELN (Atrium Research) “ An ELN is a secure system that assembles content from multiple sources that are related to each other, allows for contextual annotation, and packages it in a legally acceptable document which can be searched, mined and collaborated. ” Is this an Electronic Lab Notebook or an Electronic Lab?

Functionality (& user requirements)
Generic functions
Support a wide variety of work across a company
Enables collaboration & Knowledge Management
Best achieved by deploying a “ Thin ” layer over other systems
Discipline-specific functions
Support for each individual scientific discipline or technology
Can involve significant product & implementation costs
But delivers significant productivity benefits
Keep it simple
Users are notoriously bad at telling what they need.

Are electronic records admissible?
Records are not automatically admitted
Admissibility governed by Federal Rules of Evidence
Relevant
Reliable record of events being examined
Created contemporaneously with events
Accurate representation.
Authenticated as to their source
Testimony of a qualified witness, either present at the time of creation or the custodian.
March 10 1998, Official Gazette
Admissibility of electronic records in interferences: Pursuant to 37 CFR 1.671, electronic records are admissible as evidence in interferences before the Board of Patent Appeals and Interferences to the same extent that electronic records are admissible under the Federal Rules of Evidence. The weight to be given any particular record necessarily must be determined on a case-by-case basis.
U.S. Constitution - Article 1 Section 8 To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.

Long Term Data Preservation
File format
Standards, or lack of them
Open vs. Proprietary
Media
Long term media life unproven/questionable
CDs – 5-100yrs
Magnetic Tape – 10-30yrs
Application
How long will current applications be available or supported?
Device
How long will current hardware and operating systems be available or supported?

Technology Adoption Life Cycle Ref : ‘Crossing The Chasm’, G.A.Moore, Capstone Publishing Technology Enthusiasts Looking for some neat technology Innovators Early Adopters Early Majority Laggards Late Majority The Chasm Visionaries Looking for a breakthrough Pragmatists Looking for an improvement Conservatives Believe in tradition Sceptics Not looking!

Technology Acceptance Model Davis, F.D. “A Technology Acceptance Model for Empirically Testing New End-User Information Systems: Theory and Results”, in MIT Sloan School of Management . Cambridge, MA; MIT School of Management. 1986. Perceived Usefulness Behavioural Intention External Variables Actual Use Perceived Ease of Use Attitude Toward The degree to which a person believes that using a particular system would enhance his or her job performance. The degree to which a person believes that using a particular system would be free from effort. Individual user’s positive or negative feelings about performing the target behaviour A measure of the strength of one’s intention to perform a specific behaviour.

Technology Adoption S-curve and the Assimilation Gap Time % User Adoption Contact Awareness Understanding Trial Use Adoption Internalisation Institutionalisation Acquisition Assimilation Gap Robert G. Fichman, Chris F. Kemerer, “The Illusory Diffusion of Innovation : An Examination Of Assimilation Gaps”, Working Paper Series No.746, Katz Graduate School of Business, University of Pittsburgh, November 1995.
People are more likely to comply with a request when:
A reason is provided
There is give and take
They see others complying
The request comes from someone they respect or like
The request comes from a legitimate source of authority
Deployment

Costs – Paper vs. Electronic Paper Electronic

Success by Project Size – Small is beautiful! Standish Group International (1999)

Integration
Education
User Community Commitment
Standards – file format and messaging / interconnect
Modular Components
Stable Operating System Environment
Joe Liscouski : Integration in Laboratory Automation & Informatics http://theintegratedlab.com/integration-in-laboratory-automation-informatics/

Collaboration
The rest of the world has Plug & Play – we have Plug & Pray.
Use of social networking tools (as an ELN) are being explored, mainly in academia.
General IT trends are towards web services, Software as a Service (SaaS).Open Source.
Gartner, the technology forecasting agency, predicts that “ online social networking will come to be regarded as just the latest expression of a long-standing pattern of human behaviors that involves an increasing range of communications protocols and technologies. How to apply this in a corporate environment will be the next major challenge. ”

Summary
Is there an advantage of going electronic and implementing an ELN system
Yes, it’s a case of ‘when’, not ‘if’.
Is integrating the ELN with other informatics solutions is important.
Yes, but it is the most challenging area.
Is the “paperless lab” a truly attainable goal?
Yes (subject to what you mean by paperless).

Starting From Scratch - the ELN Reality

by John Trigg on Oct 01, 2009

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