Getting started with an Electronic Laboratory …accelrys.com/micro/notebook/documents/scw-eln-guide3.pdfGetting started with an Electronic Laboratory Notebook 7 It’s Time for a

3rd Edition

Getting started with an

Electronic Laboratory Notebook

FROM THE PUBLISHERS OF

John Trigg

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The quantity of data your laboratory produces continues to grow, and so do your data management needs. You need a head start. By integrating LIMS, SDMS and ELN, STARLIMS consolidates all types of data, from all types of laboratories, into a single platform. Streamline your lab with just a single web-based informatics system to deploy and support, even across widely distributed and global organizations.

Solid, comprehensive and flexible LIMS, ELN and SDMS— the informatics solution that powers your lab. www.starlims.com

An Abbott Company

One Platform, One Goal, One Winner

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CONTENTS

Getting started with an Electronic Laboratory Notebook 3

The quantity of data your laboratory produces continues to grow, and so do your data management needs. You need a head start. By integrating LIMS, SDMS and ELN, STARLIMS consolidates all types of data, from all types of laboratories, into a single platform. Streamline your lab with just a single web-based informatics system to deploy and support, even across widely distributed and global organizations.

Solid, comprehensive and flexible LIMS, ELN and SDMS— the informatics solution that powers your lab. www.starlims.com

An Abbott Company

One Platform, One Goal, One Winner

� is short guide provides a brief background to electronic laboratory notebooks with a speci� c focus on the factors that need to be taken into consideration when undertaking a transition from the bound paper laboratory notebook.

� e guide does not go in to great detail, as this can be readily obtained through various on-line resources, conference presentations, vendors and consultants. Furthermore, in an era of constant change, the incorporation of too much detail could mean that the guide would rapidly become out of date.

� is 3rd edition contains a number of general updates that re� ect the evolving nature of the ELN market and products. It also includes additional notes on information technology considerations in order to re� ect current trends, a brief guidance on risk assessment and an additional chapter on business case development.

AcknowledgementsA considerable amount of the original material used in this guide was derived from a series of introductory courses on ELNs run jointly by Simon Coles (Amphora Research Systems) and myself. � e additional chapter added in the 3rd edition (business case development) was developed in collaboration with Erick Gaussens and Emmanulle Dorlanne-Messiaen, both of ProductLife Consulting.

John TriggphaseFour InformaticsJanuary 2011

Contents1. Introduction 4

2. What is an ELN? 5

3. Industry evolution 8

4. Key business issues 10 ● Costs and return on investment (ROI) 10 ● Electronic records 10 ● Patent-related issues 12 ● Regulatory compliance 15 ● Data integrity and data authenticity 17

5. Key user issues 18 ● Internal culture and technology adoption 19

6. IT considerations 22

7. Business case development 26

8. Running the project 29

9. Summary 32

10. References and further reading 33

11. Appendix: ELN vendors and 34 service providers

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4 Getting started with an Electronic Laboratory Notebook

1 Introduction

Computers and information technology have penetrated almost every aspect of laboratory work over the past few decades – but, even today, scientists still turn to the bound paper notebook, a pen, scissors and adhesive tape to fully document their experiments in a way that is compliant with legal and regulatory requirements, and meets their corporate directives for intellectual property protection. However, the continued use of a reliable, convenient and trusted medium such as paper has its drawbacks too.

In an age where the rapid dissemination of information is considered fundamental to collaboration and team-working, and where easy access to existing information is essential, the right information technology infrastructure, the right tools and the right processes are critical enablers to support the creation, sharing and re-use of an organisation’s explicit knowledge.

Electronic Laboratory Notebooks (ELNs) are seen as the tool of choice to facilitate this new era of laboratory knowledge management. It may seem surprising that, at the start of the 21st century, the bound paper laboratory notebook is still the medium in which most experiments are documented, but there are some important reasons why the move away from paper has been treated with a good deal of caution. However, there is a growing trend towards implementing an electronic solution for documenting experiments, based on (a) expected productivity gains, (b) real time sharing and collaboration, and (c) an enhanced approach to managing scienti� c knowledge repositories.

� e argument for an electronic solution

is becoming increasingly powerful, as one by one the objections to the transition from paper to electronic weaken. So what are the major objections? Basically, they can be considered to � t into three categories. Firstly, from a business perspective, there have been concerns about the admissibility of electronic records in support of patent interferences and patent infringements, the costs associated with an electronic solution, and in some instances there may be concerns regarding compliance issues.

Secondly, from a technology perspective, there has been – and still exists – a certain amount of doubt about the choice of infrastructure and available technologies that are able to preserve electronic records over the long term. And thirdly, from a user perspective, there is the worry about change management and the impact upon users of replacing an established and proven documentation process.

Traditional functions of lab notebooks:

● Recording ideas● Inventions● Experimentation records● Observations● Work details

The laboratory notebook can help you prove:

● Exact details and dates of conception● Details and dates of reduction to practice● Diligence in reducing your invention to practice● Details regarding the structure and operation of your

invention● Experimentation observations and results● A chronological record of your work● Other work details

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WHAT IS AN ELN?


2 What is an ELN?

In its simplest form, an electronic laboratory notebook can be considered to be a direct replacement for the paper lab notebook. In this instance, it can provide the generic functionality to support ‘broad’ scienti� c documentation processes required for patent evidence creation, cross-discipline collaboration and general record keeping. However, the integration capabilities that we readily associate with information technology raise the possibility of a tighter coupling of other laboratory systems into the ‘electronic laboratory notebook’. In other words, can the information that is currently printed from other laboratory systems, cut

out and pasted into the paper lab notebook, be electronically entered or linked directly to the ELN? For example, systems that provide chemical structure drawing, structure and sub-structure searching, and compound registration are an integral part of the chemistry laboratory’s process, and therefore would be expected to become part of an electronic solution.

Similarly, other scienti� c disciplines will have speci� c

requirements consistent with their particular laboratory processes. Figure 1 illustrates the relationship between ‘broad’ (generic) and ‘deep’ (speci� c) systems. Another way of looking at this is to de� ne an information

Chem

ists

Broad FunctionsRecords, Patents, Cross-discipline collaboration

Biol

ogist

s

Anal

ysts

Othe

r disc

iplin

e

Othe

r disc

iplin

e

ProgrammesDocument Management

ProjectsProject Management

ExperimentsLaboratory Notebook

Interpreted/Processed DataSDM/LIMS

Raw DataLaboratory Instrumentation

‘ Systems that provide chemical structure drawing, structure and sub-structure searching, and compound registration are an integral part of the laboratory’s process’

Figure 1: Broad vs. Deep Figure 2: Information Structure

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It’s Time for a Change“ E-WorkBook Suite provides us with a tool to enable easy and

secure data recording, storage and retrieval, which will, in turn, lead to improved efficiency and enhanced decision making.

Susan Charman, Director at the Center for Drug Candidate Optimization, Monash University

”

To find out how you can achieve all this go to www.idbs.com/eln or email us at [email protected]

Europe: Guildford, UK; London, UK | North America: Alameda, CA; Boston, MA; Bridgewater, NJ | Asia Pacific: Shanghai, China; Melbourne, Australia

www.idbs.com

• Fast Project Execution • Faster Time to Market • Fastest Growing ELN Solution - E-WorkBook

Enabling Science

SCW ELN 2011.indd 1 31/01/2011 10:45:07

structure (see � gure 2) that identi� es how di� erent systems � t into the laboratory architecture. � e triangle represents the di� erent layers of abstraction that exist in R&D information � ows. � ese are almost always handled by di� erent systems. Above the experimental layer is a management context that is handled by traditional IT tools that are used elsewhere in the enterprise. Cross-discipline collaboration tends to happen around the experiment layer. Below the experiment level there is an increasing specialisation of data types and tools, and only a few systems are comfortably deployed across workgroups.

From a patent perspective, the experimental layer is crucial as it captures what the scientist is thinking and doing, and therefore will provide the evidence of conception and reduction to practice of the ‘invention’. In broader intellectual property (IP) terms, it is the experiment layer that constitutes a record of the laboratory’s work and as such contributes to the scienti� c knowledge repository. While this repository resides on paper, the ability to access, collaborate and share scienti� c knowledge is constrained. � e implementation of an ELN therefore o� ers a signi� cant opportunity to bring about greater e� ciencies in these processes.

� e generic function of an electronic laboratory notebook supports the ‘experimentation’ layer, and contains

abstractions from the lower data levels. So in terms of ‘what is an electronic laboratory notebook?’, the CENSA[1] de� nition; ‘A system to create, store, retrieve, and share fully electronic records in ways that meet all legal, regulatory, technical and scienti� c requirements’ is all encompassing, and can therefore mean di� erent things to di� erent people. For this reason, a clearly de� ned understanding of the role the electronic laboratory notebook is going to play in a given organisation is absolutely essential at the start of an electronic laboratory notebook project.

An ELN can therefore serve the organisation in three ways: � rstly, it can take advantage of the capabilities of IT to improve the ability to acquire, manipulate, share and store data (productivity). Secondly, it can facilitate communication and sharing in real time across multi-disciplinary and multi-site teams (collaboration). � irdly, it can provide a scienti� c knowledge repository that can be easily accessed to recover records of the laboratory’s work (content/knowledge management).

An ELN system (like the bound laboratory notebook) has a number of potential roles:

● A place to do science – a working environment● A place to write up the experimental work● A record of the work● A long-term preservation mechanism

It is important to separate these roles because:

● One solution is unlikely to do it all● Most companies will already have a signifi cant investment

in specifi c tools

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It’s Time for a Change“ E-WorkBook Suite provides us with a tool to enable easy and

secure data recording, storage and retrieval, which will, in turn, lead to improved efficiency and enhanced decision making.

Susan Charman, Director at the Center for Drug Candidate Optimization, Monash University

”

To find out how you can achieve all this go to www.idbs.com/eln or email us at [email protected]

Europe: Guildford, UK; London, UK | North America: Alameda, CA; Boston, MA; Bridgewater, NJ | Asia Pacific: Shanghai, China; Melbourne, Australia

www.idbs.com

• Fast Project Execution • Faster Time to Market • Fastest Growing ELN Solution - E-WorkBook

Enabling Science

SCW ELN 2011.indd 1 31/01/2011 10:45:07ELNGuide pp01-40.indd 7 16/2/11 15:11:17


3 Industry evolution

� e ELN market has been developing rapidly over the past decade [2], with continued growth, although it remains to be seen what the legacy of the global � nancial crisis will be. But the market still exhibits some degree of immaturity with a large number of vendors (in excess of 30 purveyors of products that purport to be an ELN) competing for market share. As a consequence, the market su� ers from some degree of ‘hype’ (see � gure 3). Just where ELNs sit on the Gartner Hype Cycle[3] is dependent on the view you take within your organisation and your scienti� c domain. � e general market position is probably somewhere around the ‘trough of disillusionment’, although individual vendors may occupy positions either side of this point. � e ‘trough of disillusionment’ can be considered as the turning point when we’ve got past the hype and can then focus on delivering true bene� t. Chemistry-based and generic ELNs are probably already beyond this point.

Vendor products have evolved from two approaches: discipline-speci� c and generic. Generic so� ware provides the architecture and tools to create and search content, and to work collaboratively in a way that satis� es the needs of almost any science-related industry. Discipline-speci� c ELNs are aimed at a particular market segment such as chemistry, biology or analytics. � ese systems are usually tailored to work with other discipline-speci� c so� ware tools. Most commercial ELNs o� er a

The Gartner Hype Cycle [3] – Terms explained

● Technology Trigger: The fi rst phase of a Hype Cycle is the ‘technology trigger’ or breakthrough, product launch or other event that generates signifi cant press and interest

● Peak of Infl ated Expectations: In the next phase, a frenzy of publicity typically generates over-enthusiasm and unrealistic expectations. There may be some successful applications of a technology, but there are typically more failures

● Trough of Disillusionment: Technologies enter the ‘trough of disillusionment’ because they fail to meet expectations and quickly become unfashionable. Consequently, the press usually abandons the topic and the technology

● Slope of Enlightenment: Although the press may have stopped covering the technology, some businesses continue through the ‘slope of enlightenment’ and experiment to understand the benefi ts and practical application of the technology

● Plateau of Productivity: A technology reaches the ‘plateau of productivity’ as the benefi ts of it become widely demonstrated and accepted. The technology becomes increasingly stable and evolves in second and third generations. The fi nal height of the plateau varies according to whether the technology is broadly applicable or benefi ts only a niche market

Visibility

Maturity

TechnologyTrigger

Peak of inflatedexpectations

Trough of Disillusionment

Slope of Enlightenment

Plateau of Productivity

Figure 3: The Gartner Hype Cycle [3]

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INDUSTRY EVOLUTION


combination of generic and discipline-speci� c functionality.

� e initial evolution of the ELN market was centred on the provision of functionality to support small molecule chemistry. Most of the experimental processes associated with synthetic chemistry are well established, reasonably consistent and are well supported by desktop so� ware tools. Integrating these functions in an ELN that addresses the broader capability to create, manage and store a full experimental record was a logical progression.

As a consequence, chemistry-based ELNs are well established and exhibit a good deal of maturity. If there is segmentation in this part of the market, it is determined to some extent by the origins and scope of the available products. Some, for example, will be perceived as an enterprise-wide solution, others will have more of a focus on utility and personal productivity, while others will provide a generic ELN capability that accepts the integration of third-party so� ware tools.

Biology, however, has presented a bigger challenge to the ELN vendors. � e more diverse and complex nature of biological processes and outcomes creates a need to capture not just the data, but also the complex relationships between the data. � is, coupled with a diverse portfolio of biology-speci� c so� ware tools, begs the question, do biologists just need a generic ELN that will integrate with their existing so� ware tools, or do they need a complete suite of functionality that is embedded in the ELN? � e dilemma for the biologists is whether there is a commercial ELN that addresses their speci� c and diverse requirements. Furthermore, for those companies that need to support chemists and biologists, the question is whether it is possible to � nd a single vendor solution that addresses the requirements of both disciplines,

or whether to choose the best of breed for each discipline.

Interestingly, within the past two or three years there seems to be another emerging ELN domain – that of QA/QC and the regulatory world. A few vendors have concentrated speci� cally on this area, with products that are strongly aligned to laboratory work� ows, following the step-by-step execution of SOPs or test methods. � e products are more structured than we would expect from a ‘conventional’ ELN and in some respects appear to be functionally closer to a laboratory information management system (LIMS). � is particular segment of the market has seen a number of LIMS vendors extending the functionality available in their LIMS products to embrace some of the more unstructured requirements associated with experimentation. It could be argued that such products may be better labelled as ‘laboratory execution systems’ as they follow a very prescriptive approach applicable to those communities engaged in regulatory based testing.

� e generic functionality required just to replace a paper notebook can be a simple authoring tool capable of generating a compound-document. However, additional capability will be needed for storing and searching documents, and for addressing work� ow requirements. Some organisations have chosen to implement generic ELN functionality within the framework of their standard IT tools such as Lotus Notes and SharePoint. In the academic community, blogging tools have been used to record experimental work and thus provide the basic features of an ELN, with a strong emphasis on sharing and collaboration and in the form of a laboratory journal.See the appendix on page 34 for a list of ELN vendors and service providers.

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4 Key business issues

Costs and return on investment (ROI)Any organisation considering the implementation of an electronic laboratory notebook (ELN) will want to investigate the return on investment, or cost/bene� t. � is is usually extremely di� cult to do since most of the projected bene� ts will be based on a certain amount of speculation and faith. However, there are some important points to consider in building the cost/bene� t case. � e costs associated with managing bound paper laboratory notebooks through their full lifecycle are not always fully visible or understood. Apart from the material costs, and the costs of the archive process, there is a hidden cost while the notebook is in the possession of the scientist.

� e time taken in writing by hand, cutting, pasting, and generally manipulating paper, as well as the witnessing process, all contribute to this hidden cost. It is normal in building the cost/bene� t equation to look at how much of a scientist’s time is taken up in managing the paper lab notebook, and to use this as a basis for potential time savings with an electronic solution (see � gure 4). Although the start-up costs are high for an electronic solution, the incremental cost of adding new users and increasing storage space is modest.

ROI tends to focus on the short term; how soon can we get a return on the money invested in deploying an ELN. But the true value of the ELN may be long-term and therefore far more di� cult to measure, since the value will be determined by behavioural changes. � ere is a growing body of evidence being presented at

conferences on electronic laboratory notebooks by companies that have implemented an ELN, showing that the short-term time savings associated with the electronic solution are signi� cant. Astra Zeneca, Biovitrum and Eastman Kodak, among others, have all claimed time-savings in the order of 10 to 15 per cent. But each of these organisations lists a number of other non-quanti� able, long-term bene� ts such as:

● Scientists are able to spend more time in the laboratory;

● It is easier to � nd information in a searchable archive;

● It is easier to share information;● Increased e� ciency can be achieved through

the elimination of paper;● � ere is a reduced need to repeat experiments

(knowingly or unknowingly);● Data quality (legibility) is improved;● A smooth transition when people leave the

Company; and● Online use in meetings.

If you have an ROI process, get as much help as you can to fi nd out how it works, and how to make it work successfully.Consider ‘cost versus value’ for laboratory notebooks, and think carefully about hidden costs of paper.

Electronic recordsOne of the most fundamental issues in replacing paper with electronic media is the concern over long-term data preservation. � is is an issue that every electronic records initiative has to face, regardless of scope or

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KEY BUSINESS ISSUES


scale. Whether it is government records, medical records, scienti� c records or a personal collection of digital photographs, the problem is the same; what do we have to do to ensure that we can still access these records in 50 years’ time, or more? � e track record of the IT industry in addressing long-term data preservation is not good; proprietary data formats, content tied to the application, lack of integration standards, unreliable media and a lack of a stable operating system environment all conspire to produce a major challenge in switching to electronic records.

For electronic laboratory notebooks, there are two major factors to take into consideration to guarantee the long-term preservation of records, data formats and electronic records management.

Data formatsCurrently the most common solution for electronic laboratory notebooks is to render completed experiment documents as PDF or PDF/A � les for long-term record keeping. � e portable document format (PDF),

created by Adobe Systems, has evolved into an international standard (ISO 32000) for rendering documents in a � xed layout that is device-independent. PDF/A is a standard for the long-term archiving of electronic documents and is also an ISO standard (ISO 19005-1:2005). It is a subset of PDF, leaving out features not suited to long-term archiving.

� e use of PDF or PDF/A is generally considered to be the best option for the preservation of documents for IP and legal purposes, but the long-term storage of laboratory data is a di� erent matter. � e biggest problem by far is proprietary data formats. Most laboratory instruments are not designed with long-term record keeping considerations in mind and therefore generate data in proprietary formats. In some markets, this situation is being progressively addressed by means of open platforms that provide data interchange and systems’ integration standards.

In the clinical world there is good progress, driven by the demand of health records. Unfortunately, the laboratory world does not have an equivalent driver. At the time of writing there are two initiatives attempting to address aspects of this problem. For analytical data interchange, the AnIML programme[4] is making steady headway to serve as the open-source development platform for a new XML standard for analytical chemistry information. � e Pistoia Alliance[5] is an initiative to provide an open foundation of data standards, ontologies and web-services to streamline the parmaceutical drug discovery work� ow (chemistry, biological screening, logistics) through common business terms, relationships and processes.

� e lack of laboratory data standards makes it important to establish not only how the ELN records are managed, but also how data � les are stored, and where. Although most commercial ELNs will accommodate data � les in the ELN

Figure 4: System costs of paper notebooks and ELNs

Number of users

Cost Elements•Media•Storage•Management process

Syst

em co

st

Paper

Electronic

ELNGuide pp01-40.indd 11 16/2/11 15:11:24


database, best practice is generally to store data in a separate repository, with appropriate links, and to include appropriate graphical representation of the data in the ELN; basically the electronic equivalent of pasting selected graphical instrument output into a paper lab notebook. In this way, the ELN contains su� cient information to support the conclusions of the experiment and to allow the experiment to be repeated, but eliminates the need to manage disparate proprietary data within the ELN system.

Where data resides outside of the ELN, links to this data can be made from within the ELN, but it will be necessary to take into consideration how this data and the links are managed over the long term through new revisions of so� ware.

Electronic records managementLong-term data preservation raises the question of whether the records should be stored in the ELN, or whether they are transmitted to a separate records management system, leaving the ELN to serve mainly as an operational system. For large companies, records management is typically a broader organisational process, managed by specialists, and ELNs o� en need to be integrated with an existing

records management system. For smaller companies, it will be an essential decision in the implementation project to determine just how ELN records will be managed over the long term.

Basic records management guidelines are as follows:

● Integrate electronic content/records management;

● Understand the legal implications of electronic records;

● Establish a � le plan;● Establish an electronic records preservation � le

plan;● Establish a records management team;● Train the technical team;● Establish and communicate policies;● Avoid point solutions; and● Don’t keep electronic records forever.

Patent related issues� e US patent system is based on ‘� rst to invent’ and, in order to help determine who was � rst to invent, most companies engaged in research create and preserve evidence that they can use to defend their patents at a future date. Traditionally this evidence has been in the form of the bound paper laboratory notebook. In a patent dispute,

Whether it’s on the trail or in the lab, you want the freedom to take new approaches, routes, and paths to your goals. That’s why there’s Symyx Notebook by Accelrys. It’s the only electronic laboratory notebook that can be deployed across the enterprise in multiple scientific disciplines. With Symyx Notebook by Accelrys, research teams share a single application to document, work, collaborate, and speed the experimentation workflow.

Symyx Notebook by Accelrys streamlines the capture of all experimental nformation and intellectual ideas. Everyday tasks such as data capture and note taking are optimized and automated. All of which gives you the time and freedom you need to experiment—and get back to doing science.

To learn more, visitaccelrys.com/eln

Go beyond the everyday. EVERYDAY.

© 2011 Accelrys is a registered trademark of Accelrys Software Inc. All rights reserved.

Symyx Notebook by AccelrysThe Freedom to Experiment.

General requirements for electronic records

Qualitycriteria

Material tobe preserved

Scrutiny Timescale Format

Internal use Internalrequirements

Scientifi c data. Experimental write-up

Little, if any Company defi ned XML, de factostandards, ad hoc

Regulatory 21 CFR part 11

Publishedregulations, with comment

Primarily scientifi c data. Some write-up

Regulatoryinspection

Defi ned by regulations

XML, de factostandards

Patents Case law, federal rules of evidence etc

Primarily experimental write-up. Some data

Adversarial 10 years before fi rst come under scrutiny. Retain for 50-100 years

PDF (paper,microfi lm)

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??????????????


Whether it’s on the trail or in the lab, you want the freedom to take new approaches, routes, and paths to your goals. That’s why there’s Symyx Notebook by Accelrys. It’s the only electronic laboratory notebook that can be deployed across the enterprise in multiple scientific disciplines. With Symyx Notebook by Accelrys, research teams share a single application to document, work, collaborate, and speed the experimentation workflow.

Symyx Notebook by Accelrys streamlines the capture of all experimental nformation and intellectual ideas. Everyday tasks such as data capture and note taking are optimized and automated. All of which gives you the time and freedom you need to experiment—and get back to doing science.

To learn more, visitaccelrys.com/eln

Go beyond the everyday. EVERYDAY.

© 2011 Accelrys is a registered trademark of Accelrys Software Inc. All rights reserved.

Symyx Notebook by AccelrysThe Freedom to Experiment.

ELNGuide pp01-40.indd 13 16/2/11 15:11:29


any inventor is assumed to have an interest in the outcome of the case, so their testimony must be corroborated. Most organisations require these notebooks to be signed by the author (‘I have directed and/or performed this work and adopt it as my own’) and also by an impartial witness (‘I have read and understood this work’)[6,7].

Evidence in US patent interferences is subject to the Federal Rules of Evidence. � ere are a number of important hurdles that need to be overcome; in particular the ‘hearsay rule’ (by de� nition, if the author cannot be present, then the evidence is hearsay) and the ‘business records exception’.

� e ‘business records exception’ is an exception to the hearsay rule that allows business records, such as a laboratory notebook, to be admitted as evidence if they can be demonstrated to be relevant, reliable and authentic. � e following criteria must be met: ● Records must be kept in the

ordinary course of business (e.g. a laboratory notebook);

● � e particular record at issue must be one that is regularly kept (e.g. a laboratory notebook page);

● � e record must be made by or from by a knowledgeable source (e.g. trained scientists);

● � e record must be made contemporaneously (e.g. at the time of the experiment); and

● � e record must be accompanied by testimony by a custodian (e.g. company records manager).

Any doubt about the admissibility of electronic records was largely removed by this statement from the O� cial Gazette (March 10 1998)[8]: 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. � e weight to be given any particular record necessarily must be determined on a case-by-case basis.’

In terms of admissibility, paper and electronic records are therefore equivalent. However, it is important to understand the factors that impact upon the authenticity of electronic records and that in the adversarial nature of the courtroom, the opposing side will attempt to discredit the record, the record keeping system and the record keeping

process. � e integrity of the system and the process used to create and preserve records are therefore paramount.

However, most organisations still require their scientists to keep bound laboratory notebooks. � is is because there isn’t the case law and/or other experience for most legal advisors to feel as comfortable with electronic records as they are with paper. � e issue is not one of admissibility, but of

the weight that the record will have in court. Unfortunately, we are unlikely to see a suitable body of case law for a great many years.

� e high-stakes nature of the problem, lack of experience and long-term accessibility concerns have caused a number of organisations to adopt a hybrid solution, using an ELN front-end tool to author records, and then preserving the resulting records on paper. � is gives the bene� ts of paper records (for the lawyers) whilst providing the scientists with the bene� t of new tools. A fully electronic system will require scientists to sign documents electronically and the resulting record to be preserved electronically.

‘ Most organisations still require their scientists to keep bound laboratory notebooks’

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KEY BUSINESS ISSUES


Using multiple systems for patent evidence creation and preservation can expose an organisation to increased risk. Similarly, the use of generic systems for such a task can increase discovery concerns and also increase the likelihood of problems occurring. Further guidance should be sought from records management personnel and legal advisors within the organisation in order to determine policy.

A recommended approach to help uncover and resolve legal/patent concerns is to work with lawyers and patent attorneys to simulate the presentation of ELN evidence in the court room and work back to the creation of that evidence in the laboratory.

Regulatory compliance� e FDA requirements for 21 CFR Part 11 compliance for most life science companies has been directed mainly in the area of development, manufacturing and clinical trials. 21CFR Part 11 outlines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. Typically, research or discovery tend to be outside the direct reach of Part 11, but the principles of Part 11 compliance are closely related to legal requirements and it therefore makes good sense to take these into consideration at the start of an ELN project. In this way the fundamental principles of the trustworthiness, reliability and authenticity of scienti� c evidence can be supported by a robust process that de� nes the course of the regularly conducted business activity used to create the evidence. Furthermore, should the ELN project be extended into development areas, then of course, compliance will become mandatory.

In order to meet regulatory requirements, the following criteria typically apply:

● � e system must be validated;● � e system should produce human readable

output;● � e system should have security/access control;● � e system should have an audit trail;● � e system should have version control;● � e system should have data validity checks;● � e system should provide an electronic

signature process for all signed electronic records that includes:

● � e printed name of the signer;● Date and time of signature execution;● Meaning of signature;● Establish corporate internal policies and

guidelines for regulatory compliance;● Validation policy and procedures;● Disaster recovery;● Revision and change control procedures;● System access and security procedures;

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ELNGuide pp01-40.indd 16 16/2/11 15:12:39

KEY BUSINESS ISSUES


● Training procedures; and● Document control procedures;

● Develop a clear, comprehensive migration strategy including records, signatures and an audit trail; and

● Establish retention policies based on current predicate rule requirements.

Data integrity and data authenticityWhenever electronic records are used within the framework of legal or regulatory compliance, data integrity and data authenticity are fundamental requirements of the computer systems used to create, manipulate, store and transmit those records. � ese requirements may also apply to in-house intellectual property (IP) protection requirements. It will therefore be necessary for an ELN implementation project to very carefully consider the speci� c requirements of their organisation in this area.[9]

Data integrity, in a general sense, means that data cannot be created, changed, or deleted without authorisation. Put simply, data integrity is the assurance that data is consistent, correct, and accessible.

It also has a systems-based meaning that data stored in one part of a database system is consistent with other related data stored in another part of the database system (or another system). Although this is a critical requirement from a data management perspective, it is the broader meaning of data integrity that is relevant to the compliance issues.

Data integrity can be compromised in a number of ways: ● Human error during data entry; ● Errors that occur when data is transmitted from

one system to another;

● So� ware bugs or viruses; ● Hardware malfunctions; and ● Natural disasters.

� ere are many ways to minimise these threats to data integrity. � ese include: ● Backing up data regularly; ● Controlling access to data via security

mechanisms; ● Designing user interfaces that prevent the input

of invalid data; and ● Using error detection and correction so� ware

when transmitting data.Data authenticity is the term

used to reinforce the integrity of electronic data by authenticating authorship by means of electronic signatures and time stamping. Generally speaking, electronic signatures are considered admissible in evidence to assure the integrity and authenticity of electronic records.

An electronic signature is a generic term used to indicate ‘an electronic sound, symbol, or process, attached to or logically

associated with a record, and executed or adopted by a person with the intent to sign the record.’

A digital signature is a speci� c sub-set of an electronic signature that uses a cryptographic technique to con� rm the identity of the author, based on a user name and password, and the time at which the record was signed.

� e requirements for an ELN project will be somewhat dependent on the nature of the organisation’s business and internal requirements, but security, access control and electronic signatures are factors that must be given appropriate consideration. An increasing number of commercial ELNs now o� er work� ows with electronic signature integration.

‘ Data authenticity is the term used to reinforce the integrity of data by authenticating authorship by means of electronic signatures and time stamping’

ELNGuide pp01-40.indd 17 16/2/11 15:12:47


5 Key user issues

� e inherent ambiguity of the term ‘electronic laboratory notebook’ (ELN) o� en leads to it becoming all things to all men. Gathering user requirements is one of the key tasks, usually assigned to the project team, in order to provide a speci� cation against which potential solutions can be evaluated. � e output from this task can result in a very long and complex list of features, and even if the business can a� ord to include in the ELN, users may � nd the resulting system too complex to work with.

Gathering requirements involves uncovering and understanding user needs, and continuous testing of solutions against those needs. In order to do this, qualitative and quantitative methods are required and need to be aligned to project phases. Unfortunately, users are notoriously bad at telling what they need. Most ELNs are speci� ed or designed by a team or committee and the team/committee members tend to be volunteers who are committed to the concept of an ELN, enthused about the improvements it can bring, and can envision the potential.

Unfortunately, the committee process can create complex systems and re� ect compromises, and it is o� en the case that most problems come from people who don’t volunteer for ELN committees! By de� nition the members of the team are more committed to the success of ELN than those who are not directly involved. In their deliberations, project teams o� en develop a concept of an ‘ELN’ that is much more sophisticated than might be needed or indeed is economically justi� able.

It is a hard truth that the majority of ELN

users don’t really care all that much about the ELN – they just want to do their jobs. If they cared that much, they would be on the ELN team! Any single item on the requirements list should justify itself not only � nancially, but also in terms of its usefulness and ease of use.

Useful diagnostic questions:‘Do we have this functionality already?’ (either in an existing IT system, or in the paper notebook)● No – why is this part of the ELN? O� en an

ELN project becomes a vehicle for people’s pet projects; or

● Yes – can the ELN integrate with this existing system?

‘Does this function apply to all scientists, or just a subset?’● All – likely to be a ‘broad’ requirement; or● Subset – likely to be a ‘deep’ requirement and

should be justi� ed by that particular (sub) project.

Anecdotal experience suggests that some requirements speci� cations could be shrunk by between 25 and 50 per cent by the removal of ‘wish list’ items – bringing cost savings and lower cost of ownership, as well as easier user adoption.

It is important for the project team and sponsors to be able to de� ne what business problem the ELN will solve, and to ensure that user requirements are kept simple and are focused on solving the problem.

ELNGuide pp01-40.indd 18 16/2/11 15:12:48

Figure 5: ‘Crossing the Chasm’

KEY USER ISSUES


ConservativesBelieve in tradition

ScepticsNot looking!

PragmatistsLooking for an improvement

VisionariesLooking for abreakthrough

Technology EnthusiastsLooking for some neat technology

Innovators Early Adaptors

Early Majority

Late Majority

Laggards

The Chasm

User culture

Innovators Two to three per cent

Technology Enthusiasts: want to be fi rst to try new technology; want one of everything

Early Adopters

10 per cent Visionaries: able to align technology with strategic opportunities; willing to take risks; horizontally oriented

Early Majority 36 per cent Pragmatists: cautious with risk and money; loyal; vertically oriented

Late Majority 36 per cent Conservatives: opposed to discontinuous innovation; believe in tradition rather than progress

Laggards 15 per cent Sceptics: negative attitude towards technology; identify discrepancies between what’s promised and what’s delivered

Internal culture and technology adoption� e introduction of multi-user IT systems into organisations has a mixed track record. Multi-user systems are usually speci� ed by a project team and o� en contain a number of compromises and assumptions about the way people work. High-level business objectives can therefore be put in jeopardy if users do not successfully adopt the new system. However, most case studies on electronic laboratory notebook implementations indicate a positive user take-up. � is may be attributed to the growing understanding of aspects of technology adoption, originally reported by Everett Rogers in his book � e Di� usion of Innovations [10],

and developed further by G. Moore in Crossing the Chasm[11]. Moore’s ‘Chasm’ (see � gure 5) is the gap between the early adopters and the mainstream market. � e early adopters are a relatively easy market.

Targeting them initially is important, but the next phase of the marketing strategy must target the conservative and pragmatic majority. � e early adopters can play a central role in this. Since the ELN project team is likely to be formed from the early adopters, they can play a pivotal role not only in specifying and selecting a solution, but in articulating the rationale for the ELN, providing training and ongoing support to the conservative and pragmatic majority.

ELNGuide pp01-40.indd 19 16/2/11 15:12:51


User adoption is o� en considered one of the most critical success factors of an IT project, and paying appropriate attention to user requirements will enhance the likelihood of success. Key to this is the recognition that people are more likely to comply with a request when:● A reason is provided;● � ere is give and take;● � ey see others complying; ● � e request comes from someone they respect

or like; or ● � e request comes from a legitimate source of

authority.Concerns about user adoption can be

reduced by carefully choosing the project team to ensure that these criteria are addressed, rather than just announcing a new system and the training course schedule. Typically, putting a strong emphasis on user requirements and adoption by engaging users throughout the process tends to brand the implementation as a ‘laboratory’ project, rather than an ‘IT’ project, and this can o� en make it easier for scientists to accept the proposed change.

� e Technology Acceptance Model [12] is an

information systems theory that models how users come to accept and use a technology. � e model suggests that, when users are presented with a new so� ware package, a number of factors in� uence their decision about how and when they will use it. � e main ones are: ● Perceived usefulness (PU) – ‘the degree to which

a person believes that using a particular system would enhance his or her job performance’; and

● Perceived ease-of-use (EOU) ‘the degree to which a person believes that using a particular system would be free from e� ort’.

� e technology acceptance model assumes that, when someone forms an intention to act, they will be free to act without limitation. In the real world there will be many constraints, such as limited ability, time constraints, environmental or organisational limits, or unconscious habits which will limit the freedom to act.

Concentration on the positive aspects of ‘usefulness’, both to the organisation and to the individual, and ‘ease of use’ will help users develop a positive attitude. It is in this area that the early adopters can have a powerful in� uence of their conservative and pragmatic peers.

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ELNGuide pp01-40.indd 1

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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 usinga particular system would be free from effort

A measure of the strength of one’s intention to perform a specific behaviour

Individual user’s positive or negative feelingsabout peforming the target behaviour

ExternalVariables

PerceivedEase of Use

Attitude Toward

ActualUse

BehaviouralIntention

PerceivedUsefulness

Figure 6: Technology adoption model

ELNGuide pp01-40.indd 20 16/2/11 15:12:55

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Need to know about informatics?

Scientifi c Computing World is the only global publication for scientists and engineers

using computing and software in their daily work. Laboratory informatics is central to

our coverage, with a special section in the print magazine and two supplements each

year: Getting started with an Electronic Laboratory Notebook, published in the Spring;

and our Laboratory Informatics Guide, distributed with the December/January issue.

If you need to know about laboratory informatics then you need to read Scientifi c Computing World

*Subscription is free for qualifying individuals

Published by Europa Science Ltd, The Spectrum Building, The Michael Young Centre, Purbeck

Road, Cambridge, CB2 8PD, UK. Tel: +44 (0)1223 211170. www.europascience.com

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6 IT considerations

� e primary requirement for an ELN implementation is that the system can be deployed within the organisation’s existing IT infrastructure. � e IT Department will be able to advise how this can be achieved, and how the proposed solution will integrate with existing investments. It will be important to take into consideration geographical distribution. In wide area networks, latency becomes the most noticeable issue and acceptable ‘maintenance windows’ may disappear if the implementation extends over multiple time zones. In time, the system will need to accommodate growing volumes of data, both in terms of the number of data items and the size of individual data items. Additionally, the number of users will generate more disparate requirements, not the least of which is the concern of how many people will get upset if the system goes down.

With regard to devices, successful deployments have been made with:● Small form-factor PCs on the laboratory bench;● ‘Remote desktop’;● Citrix; and● A KVM switch operating between a desk-bound

processor unit with keyboards and screens on the desk and in the laboratory.

Mobile devices such as tablets, laptops, and smartphones have been less successful in � xed laboratory environments. However, they o� er an e� ective solution where there is a speci� c need for mobility. � e increased market penetration of smartphones and tablets in the consumer market has led to an increased interest in their potential in a business context

through the deployment of dedicated ‘apps’, or browser-based access. In general, small format handheld devices o� er good access to data and information, but are typically limited when it comes to data input. Concurrent with this interest in mobile devices, is the deployment of ‘cloud’-based infrastructures that provide hosted services.

� is approach brings with it opportunities to deploy rapidly, at low cost with little or no capital expenditure, but does raise questions about security, data integrity and data

ELNGuide pp01-40.indd 22 16/2/11 15:12:59

INFORMATION TECHNOLOGY


ownership. Some ELN vendors already o� er this type of service. Cloud services generally fall into one of two categories: public clouds and private clouds. Public clouds utilise a single code base for the service to multiple clients. � e single code base limits customisation and integration, but helps keep costs down. A private cloud will typically o� er a code base speci� c to an individual client, and will accommodate customisation and integration, but will normally come at a higher management cost. Interest and uptake for ELNs is somewhat constrained by IP, legal, regulatory and security concerns. Additionally, at the time of writing, cloud computing is su� ering considerable hype; there is little doubt that in some markets, the bene� ts of the cloud outweigh the risks, but in established laboratory environments, the case is unproven.

Most of the short-term bene� ts of deploying an ELN are associated with personal and laboratory productivity; however, the long-term bene� ts may accrue from the accumulated content of the ELN information/knowledge repositories. � is may raise further IT considerations over time with regard to how this information is managed and used. � is means that the provision of adequate data storage space must be taken into account. As the volumes of data grow, there is likely to be an increasing need for better search and visualisation technologies than are typically available today. In addition, consideration must be given to the nature of the data and how it can be e� ciently stored, retrieved and interpreted. For these purposes, it is necessary to distinguish between the content of the ELN (experimental write-up) and external

data (laboratory data) to which the write-up may be electronically linked. Over time, they may present two separate data preservation problems. Laboratory data is o� en stored in proprietary formats, so forward compatibility to future application and operating system releases will be critical. Additionally, the location of these � les will need to be managed carefully to avoid breaking electronic links.

Electronic records management is therefore a key function to be considered from the start of a project, and will require the assignment of adequate resources, from an IT perspective

as well as a records management perspective, in order to realise the long-term bene� ts of a growing knowledge repository (See section on electronic records management).

� e introduction of an ELN to a laboratory raises the question of how easy is it to make data available to the ELN from other laboratory systems; for example, do the data formats need to be converted to make them accessible? How easy

is it to get results, spectra, chromatograms, images, reports, etc. stored on Laboratory Information Management Systems (LIMS) into the record of an experiment stored in an ELN, and how easy was it to get the results, spectra, chromatograms, images, etc. into the LIMS in the � rst place? � e question of integration is paramount to the future of e� cient laboratory information management, not only from the perspective of record keeping, but also for productivity and real-time collaboration. � e issue here is not the format of the � nal document, but the format of the underlying data, and this is an area where proprietary � le formats have dominated.

‘Most of the short-term benefi ts of deploying an ELN are associated with personal and laboratory productivity’

ELNGuide pp01-40.indd 23 16/2/11 15:13:00

iLabber Electronic Lab Notebook stores all your experiment records in one searchable and safe place. iLabber enables your R&D team to spend more time in the lab and to collaborate instantly. It’s easy to use and the information you care about is at your fingertips regardless of your geographic location. iLabber is used by Fortune 500 companies, Biotech´s and leading Medical Universities.

The easiest way to keep track of your laboratory work

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ELNGuide pp01-40.indd 24 16/2/11 15:13:02

INFORMATION TECHNOLOGY


iLabber Electronic Lab Notebook stores all your experiment records in one searchable and safe place. iLabber enables your R&D team to spend more time in the lab and to collaborate instantly. It’s easy to use and the information you care about is at your fingertips regardless of your geographic location. iLabber is used by Fortune 500 companies, Biotech´s and leading Medical Universities.

The easiest way to keep track of your laboratory work

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If we step outside the laboratory for a moment and look at some of the developments in other domains, one of the most striking advances is occurring in the framework of collaboration and the role of Web 2.0. � e use of social networking tools has illustrated how technology can enhance collaboration once some rudimentary data standards are in place. � e relative ease of incorporating text, audio, images and video into a compound document (web page) with links to other documents and references to similar documents is, in principle, akin to the role of the ELN. Furthermore, this approach does not require anything much more than an internet browser to gain access to the document, which means (a) that the document is easily available from anywhere with internet access and (b) it is device-independent; i.e. any device that can run a browser should, within reason, be able to access, display and provide editing capability to the document.

Web 2.0 is the generic term used to identify the evolving change in the role of the internet as it becomes a collaboration space rather than just a presentation space. � ere are two basic principles behind this. � e � rst is that so� ware applications run on the web itself rather than on the desktop. � is changes the nature of the web from a collection of destination sites, to a set of sources, both of data and of functionality that can all be integrated to create the applications we need. � e second principle is that of participation; of people making these web applications more useful even as they work with them. � at usually means contributing their own knowledge, by sharing the data they manipulate through these applications.

Web 3.0, the semantic web, promises even

more in the sense that adding metadata, i.e. more meaning, to the data and information on the web, will enhance the capability of the technology to understand content and therefore take some of the burden of intelligently � nding and � ltering information within a given context. If this goal is successful, it promises further personal productivity gains.

So what does the future hold for ELNs? Perhaps the answer to that question is made more di� cult by the inherent ambiguity in the term ‘electronic laboratory notebook’. In most cases the implementation of an ELN is expected

to do more than just replace the paper lab notebook. When we think of an all-electronic laboratory, the ability to integrate other systems to the ELN adds increasing degrees of complexity, but also makes the dividing line between the di� erent systems more di� cult to de� ne. So, is the ELN just the authoring tool, integrated with a number of discipline speci� c tools that support the science conducted in the laboratory?

In a similar vein, is a LIMS just a database and a reporting tool that provides a data repository for laboratory data and a means to search and collate results? If this is the case, then we might envisage a collection of so� ware modules that are designed to work together, using standard data formats that can be readily assembled and re-assembled to support speci� c laboratory processes and work� ows. To achieve this, a di� erent approach is required. It is necessary to consider a holistic approach to laboratory data management that is less application-centric and addresses fundamental business processes such as collaboration, IP protection and records management.

‘ It is necessary to consider a holistic approach to laboratory data management that is less application-centric and addresses fundamental business processes’

ELNGuide pp01-40.indd 25 17/2/11 14:04:55


Building a good business case requires a thorough and systematic approach to understanding current limitations and future requirements for the business. It is important to see the ELN as a component in a laboratory ecosystem (technology, processes and people), rather than ‘just another laboratory application’. � e following points should all be considered in formulating the case for an electronic laboratory notebook.

Why an ELN?● What is the problem that needs to be solved?● Is there any quantitative data that illustrates the

problem?● Which laboratory areas will be involved in the

project?● Who makes the go/no-go decision?● What are the issues relating to IP (internal/legal/

patent)?● Are there any regulatory compliance

requirements?Clarify why the organisation thinks it needs

an ELN. � is is best achieved by developing a problem statement that quanti� es a speci� c problem, or set of problems, about the laboratory’s productivity and/or knowledge management performance. � e scope and scale of the problem (and hence, the solution) should be identi� ed. � e key decision-makers/budget-holders should also be identi� ed, plus any other interested party who may have in� uence over a go/no-go decision. It is important to know what business-level constraints may apply in terms of internal, legal or regulatory compliance.

Laboratory/company background● Use organisation charts to clarify roles and

responsibilities and organisational relationships;● Identify the nature and scienti� c disciplines of

the laboratory work and how they relate to each other; and

● Ask if outsourced agencies are involved?Establish the way in which the laboratory is

organised, the nature of the work it undertakes and how it relates to internal and external organisations with whom it collaborates.

Current laboratory processes and systems● How is the paper lab notebook used (is there an

SOP?)● Which laboratory systems are already in use?● Which data acquisition systems are already in

use?

7 Business case development

ELNGuide pp01-40.indd 26 16/2/11 15:13:05

BUSINESS CASE DEVELOPMENT


● Which teamwork/collaboration systems are already in use?

● Which document management systems are already in use?

● Who is responsible for the management and support of these systems?

● Is there an electronic records management policy? and

● Are there any speci� c policies and restraints relating to the introduction of IT systems?

Establish how the laboratory is currently working, paying speci� c attention to the use and e� ectiveness of the paper lab notebook. Also identify major ‘electronic’ systems used for the acquisition, processing and management of data, and what happens to this data; where is it stored and for how long? Is it communicated or transferred elsewhere – if so, how? Is it backed up and/or archived? Can it be found? Is laboratory data the responsibility of the laboratory, or does IT have any involvement? What level of involvement does IT have in the purchase and implementation of laboratory systems?

Future laboratory processes and systems:● Based on interviews with laboratory managers

and laboratory sta� , formulate a model that illustrates the major relationships between laboratory data and information;

● Construct data work� ow and laboratory process diagrams;

● Identify any con� icts in nomenclature and establish an agreed taxonomy;

● Identify the role of existing laboratory systems in the model and diagrams; and

● Test the model and diagrams against each of the laboratory areas and other interested parties (IT, legal, QA, records management)

Put together a high-level plan showing the relationships, processes and data � ows that describe a future state for the laboratory. � is

should include an identi� ed role for each of the laboratory systems and clarify the speci� c function of the ELN. Any problems with laboratory terminology should be resolved. � e plan should be tested by presentation and discussion with the interested parties.

Business plan development● Quantify the bene� ts of the proposal, in particular productivity gains, ROI and knowledge management, and support these estimates with case studies;● Undertake a risk assessment, paying attention to process, technology and people-related risks. Align the risk assessment to the set of user requirements; and● Prepare, and include in the business case, a high-level implementation plan that addresses any speci� c requirements and/or risks that have been identi� ed.

Quantitative bene� ts should be identi� ed, along with all risks. An implementation plan should address known risks and/or potential problems, in particular the strategic approach to roll out, e.g. a progressive deployment, the composition of the project team, change management and user support.

Human factors● What practical problems do laboratory workers

experience with existing laboratory processes and data work� ows?

● How well will laboratory workers accommodate change? and

● Are there any cultural, political or other internal relationships that could have an impact on the project?

Identify potential problems associated with the change from paper to electronic notebooks. � is may be at an individual level (early adopters vs. laggards) or at an organisational level; R&D vs. legal, R&D vs. IT, for example.

ELNGuide pp01-40.indd 27 16/2/11 15:13:06


thinking about an ELN?having concerns?does the feedback we get help...?

affordable

quick to implementeasy-to-use

out of the boxsaves time

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ard

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cross-discipline

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simple

user friendly

friendly support

cost effective

didn’t need to buy new stuff well tho

ught-out

low overhea

dunique

helpful

open

flexible

works with what we do alreadyinnovative

elegant

adaptable

control

would never go bac

k

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ELNGuide pp01-40.indd 28 16/2/11 15:13:07

RUNNING THE PROJECT


8 Running the project

� e � rst step towards making a decision to start an ELN project is to work out what problem the ELN has to solve. Take a close look at the existing process for managing paper lab notebooks through their full life cycle: ● Is anything broken? ● Are there ine� ciencies in the process? ● Is there any missing functionality? ● Are there any inherent weaknesses in the paper

system that information technology can solve? and● What are the full costs of preserving paper lab

notebooks through their life cycle?Use any existing processes you have in your

organisation to analyse the current situation (root cause analysis, six sigma, cause and e� ect/� shbone, etc.) in order to help you identify the problem that the ELN has to solve.

How to choose an ELN solution?Once you have identi� ed the problem and a set of requirements for solving the problem, then you need to consider the potential solution. Since the term ELN can be quite ambiguous, it is important to establish whether your ELN will be

a direct replacement for a paper lab notebook and its associated work� ows, or will need to include additional functionality to support discipline-speci� c functions, and/or will need to provide interfaces to other systems. Project teams need to focus on what is really critical – most requirements lists are wish lists.

Other things to consider● How long do you need to retain lab notebook

records and how are you going to do this?● Which company IT standards will need to be

considered?● Are your patent attorneys and corporate lawyers

comfortable with electronic records? and● Do you have any regulatory compliance

requirements to take into consideration?

Who needs to be involved?Although scientists have a strong sense of ownership of their paper laboratory notebooks, there are a number of other people in the organisation who have a vested interest in their use and contents. Each may take a di� erent strategic

thinking about an ELN?having concerns?does the feedback we get help...?

affordable

quick to implementeasy-to-use

out of the boxsaves time

straightforw

ard

protects IP fast ROI

cross-discipline

painless

scalab

le

secu

re

simple

user friendly

friendly support

cost effective

didn’t need to buy new stuff well tho

ught-out

low overhea

dunique

helpful

open

flexible

works with what we do alreadyinnovative

elegant

adaptable

control

would never go bac

k

responsivedoesn’t get in the way

not restrictive

slots in

dynam

icorgan

ized

Paten

tSafe - the most popular rep

lace

men

t for the boun

d lab notebook

give us a call to find out more0845 230 0160

:-)

amphorar e s e a r c h s y s t e m s

web: http://amphora-research.come-mail: [email protected]

telephone: +44 (0)845 230 0160

Interested party Area of interest

Scientists Providing functionality to improve personal productivity

Laboratory management Productivity improvementCostsCulture change

Legal department/patent attorneys

IP protectionSubmission of electronic fi les in patent interference and infringement cases

Quality control/compliance Regulatory compliance

IT Compliance with company IT standards

Records management Long term preservation of electronic records

ELNGuide pp01-40.indd 29 16/2/11 15:13:10


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viewpoint. Consider whether there are any competing and con� icting interests. � e following table lists ‘interested parties’ and their area of interest, and who should therefore be involved in a decision to switch from paper to electronic.

Things to be wary of:� e areas of most concern to an ELN project are● How to provide the essential functionality to meet

scientists’ needs;● How to choose the right technologies to support

integration and avoid lock-in to proprietary standards;

● How to gain the con� dence of the organisation’s lawyers and Patent Attorneys to support the switch to electronic records;

● How to preserve electronic records over the long term; and

● How to cope with the user/cultural issues associated with the transition from a paper process to an electronic solution.

Risk assessmentAn e� ective risk assessment is an important component of a successful IT deployment project with the goal of protecting the organisation and its assets from any foreseeable risk associated with the project. In the case of an ELN, these assets include the organisation’s IP, the performance of its scientists, as well as laboratory and IT assets. A risk assessment process is normally an essential management function within the organisation and should be applied to the ELN deployment project. � e major areas of risk that need to be considered include those points listed in the previous section (things to be wary of) as well as:● Vendor and product suitability;● Infrastructure compatibility;● Ongoing maintenance/support/development;● Deployment failures;● Costs/ROI; and● Change management.

Running the projectELN projects are best seen as laboratory rather than IT projects. Select your project team(s) carefully to ensure that the ‘science’ has priority – but that all interested parties are represented. ● Keep the solution simple;● Concentrate on ease-of-use and usefulness;● Recognise that some people have a resistance to

technology;● Establish and articulate a well-de� ned purpose

and a compelling reason to adopt the solution;● ‘Market’ the project; don’t ‘sell’ it;● Avoid the big bang; target a niche area to start; and● Implement a vertical support structure (local peer

support, transferable to the late majority and laggards).

Good project management skills will be essential, but good leadership skills will be at least as important in order to handle communications and to help users come to terms with the transition from paper to electronic.

Early adopters can play a critical role in the project’s success by taking on the responsibility for communication, training and support for the conservative and pragmatic majority.

Kicking o� with a pilot implementation is a preferred approach for deployment, and a successful pilot will provide the basis for further investment to underwrite a full scale production roll-out. � ere is a growing body of evidence being reported through case studies, that when due consideration has been given to issues such as legal acceptance of electronic patent evidence, return on investment, long-term preservation of electronic records and user acceptance, real bene� ts in terms of time savings and operational e� ciency are accruing. For example, Eli Lilly Astra Zeneca are among a number of companies that have reported a fully electronic, company-wide roll-out of a commercial ELN based on the positive outcome of a pilot implementation that addressed the key business issues listed above.

ELNGuide pp01-40.indd 30 16/2/11 15:13:14

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Translating Samples into Discoveries…

Visit us at: www.SapioSciences.com

SampleMgmt

ElectronicLab

Notebook

AssayDataMgmt

DataMining

IntegratedData

Analysis

ExemplarLIMS

Sapio Sciences A5 ad.indd 1 2/7/11 3:37:11 PMELNGuide pp01-40.indd 31 16/2/11 15:13:17


9 Summary

A key element of managing a successful implementation is to keep a manageable balance between achieving the business, user and technology requirements. Using a stage/gate process will help control investments and manage resources, but a critical success factor will be associated with user adoption. It is therefore important that the area targeted for the initial implementation should have a high likelihood of success (on time, in full, no errors) in order to get a positive response from users and to send out a positive message to management.

Business requirements● Establish what the problem is that the ELN will

solve:● Concentrate on real task activities, ease of

use and low risk of failure;● � ink about broad vs. deep; plan for both, even

if you only implement one;● For legal/patent concerns, start in the court

room and work back, with the help of your legal department;

● Establish an (electronic) lab notebook policy, if you do not already have one; and

● Establish an electronic records management policy, if you do not already have one.

User requirements● Be wary of complex user requirements:

● Keep the solution simple;● Concentrate on ease-of-use and usefulness;

and● Recognise that some people have a resistance

to technology.

● Communicate:● Establish and articulate a well-de� ned

purpose and a compelling reason to adopt;● Market the project; don’t ‘sell’ it; and● Involve everyone with a vested interest.

● Select your project team(s) carefully to ensure all users are represented.

(Users are scientists, managers, lawyers, records managers, compliance managers, IT, etc. Scientists: all disciplines, early adopters, early majority, late majority, laggards)

Technology ● Decide on a fully electronic or hybrid solution;● If you choose fully electronic, give a lot of

thought to data formats for long-term data preservation;

● Evaluate your infrastructure (physical and logical) with regard to long term records preservation and integration; and

● Give consideration to appropriate devices for laboratory use;

● Location:● Mobility:● Data input methods;● Readability; and● Security.

Implementation● Use a stage/gate approach to control investment

and resources;● Consider project leadership and management;● Avoid the big bang; target a niche area to start;● Implement a vertical support structure (local

peer support, transferable to the late majority and laggards).

ELNGuide pp01-40.indd 32 16/2/11 15:13:18

REFERENCES


10 References and further reading

References1. CENSA: � e Collaborative Electronic Notebook Systems Association www.censa.org2. Atrium Research www.atriumresearch.com3. � e Gartner Hype Cycles www.gartner.com4. � e AnIML Programme http://animl.sourceforge.net/5. � e Pistoia Alliance www.pistoiaalliance.org 6. Using Electronic Records in Patent Proceedings, article by Damien McCotter and Peter Wilcox. Originally published in Managing Intellectual Property’s World IP Contacts Handbook, 14th edition, 2007. Available at www.mondaq.com 7. IP Expert Advice: Tips on creating a lab notebook that contains ‘convincing

evidence’ www.edn.com/article/CA6445886.html?industryid=470488. Admissibility of Electronic in Interferences, Bruce H. Stoner Jr., chief administrative patent judge, www.uspto.gov/web/o� ces/com/sol/og/con/� les/cons119.htm9. � e ABCs of Electronic Signatures, David Nettleton, Lab Manager Magazine, 9 September 2010 www.labmanager.com/articles_pf.asp?ID=70710. Di� usion of Innovations, Everett M. Rogers, � e Free Press, New York11. Crossing � e Chasm, G.A.Moore, Capstone Publishing12. Bagozzi, R. P., Davis, F. D., & Warshaw, P. R. (1992). Development and test of a theory of technological learning and usage. Human Relations, 45(7), 660-686

Further readingWriting the Laboratory Notebook, Howard M. Kanare, An American Chemical Society Publication.Why Innovation Fails, Carl Franklin, Spiro Press� e Myth of the Paperless O� ce, Abigail J. Sellen and Richard H. R.Harper, � e MIT Press.Laboratory Notebook Guidelines : www.bookfactory.com/ BookFactory, LLC, 2302 S. Edwin C. Moses Blvd, Dayton, OH 45408.

WebsitesphaseFour Informatics: www.phasefour-informatics.comScienti� c Computing World: www.scienti� c-computing.com� e Integrated Lab: www.theintegratedlab.com

ELNGuide pp01-40.indd 33 16/2/11 15:13:26

Agilent Technologieswww.agilent.com/chemsoftware

Ardenno Solutions+1 610 203 8475www.ardenno.com

Atrium Research+1 972 947 3124www.atriumresearch.com

Axiope+44 (0)131 516 2963www.axiope.com

Censa+1 781 395 3004www.censa.org

Cheminnovation+1 858 780 0371www.cheminnovation.com

Cognium Systems+33 970 465 329www.cogniumsystems.com

Core Informatics+1 866 823 0337www.coreinformatics.com


Appendix

Amphora Research Systems PO Box 3940BracknellBerkshireRG42 2XNUKTel: +44 (0) 845 230 0160Email: [email protected]

Amphora’s ELN solutions are used across all disciples to enable collaboration, free the scientist from the restraints of the bound notebook and reassure lawyers.

Accelrys10188 Telesis CourtSuite 100San DiegoCA 92121USATel: +1 858 799 5000Email: [email protected]/eln

Symyx Notebook by Accelrys is a multi-disciplinary ELN that enables labs to benefi t from going paperless by connecting scientists, instruments and software in regulated and non-regulated environments.

11

ELNGuide pp01-40.indd 34 16/2/11 15:13:31

DeltaSoft+1 908 595 9777www.deltasoftinc.com

Edge Software+44 (0)23 8041 1098www.edge-ka.com

E-nnovate+1 858 752 4485www.e-nnovate.com

enso Software+49 606 291 0888www.enso-software.com

eOrganized World+1 925 229 1688www.eorganizedworld.com

APPENDIX


Contur Software ABBirger Jarlsgatan 33SE-111 45 StockholmSwedenTel : +46 (0)8 663 7000Email: [email protected]

Contur Software delivers ELN solutions to R&D organisations worldwide. The core product, ConturELN, is designed to provide one common platform for collaboration and IP protection.

CambridgeSoft 1 Signet CourtSwann’s Road Cambridge CB5 8LA UKTel: +44 (0)0800 875 20000www.cambridgesoft.com

CambridgeSoft is a leading supplier of discovery, collaboration and knowledge enterprise solutions to the pharmaceutical, biotechnology, and chemical industries around the globe.

IDBS2 Occam CourtSurrey Research ParkGuildfordSurrey GU2 7QBUKTel: +44 (0)1483 585 000Email: [email protected]

IDBS is a unique, global supplier of innovative data management and fi rst-in-class analytics solutions which increase effi ciency, reduce costs and improve the productivity of R&D organisations.

ELNGuide pp01-40.indd 35 16/2/11 15:13:39

Evernote+1 408 204 4009www.evernote.com

EZQuant+972 54 430 5533www.ezquant.com

iAdvantage software+1 919 469 3888www.iadvantagesoftware.com

Infotrieve+49 221 660 670www.infotrieve.de

KineMatik+353 21 429 7598www.kinematik.com

Knowligent+1 800 796 4280www.knowligent.com

Labkey+1 206 701 9975www.labkey.com

Laboratory Data Solutions+44 (0)1904 686 067www.labnotes.com

LABTrack+1 949 528 3840www.labtrack.com

Labvantage+44 (0)1494 477 977www.labvantage.com


Sapio Sciences400 E. Pratt Street Suite 800BaltimoreMD 21202Email: [email protected]

Exemplar provides LIMS functionality and a confi gurable E-Lab Notebook. It includes integrated data management and supports both biology and chemistry experiment and data tracking.

Labtronics546 Governors Rd. Guelph Ontario N1K 1E3CanadaTel: +1 519 767 1061Email: [email protected] www.labtronics.com

Nexxis ELN is a versatile, web-based solution for both R&D and QA/QC that easily integrates with all lab systems. Exclusive ReDI Technology ensures rapid deployment.

ELNGuide pp01-40.indd 36 16/2/11 15:13:45

Labware+44 (0)161 927 5600www.labware.com

Mettler Toledo+44 (0)116 234 5005 / (0)116 235 7070www.mt.com

NoteBookMaker+1 203 675 9010www.notebookmaker.com

phaseFour Informatics+44 (0)20 8621 0389www.phasefour-informatics.com

Rescentris+1 614 436 6488www.rescentris.com

Siemens+32 253 62111www.siemens.com/industrial-it/lims

Textco BioSoftware+1 603 643 1471www.textco.com

Tripos International+1 314 647 1099www.tripos.com

Velquest Corp+1 508 497 9911www.velquest.com

Xyntek+1 215 493 7091www.xyntekinc.com

APPENDIX


Starlims4000 Hollywood Blvd Suite 515S, Hollywood FL 33021, USATel: +1 954 964 8663Fax: +1 954 964 8113Email: [email protected]

Starlims Electronic Notebook has been designed for use in highly-regulated environments, including QA/QC labs operating under GxP, ISO 17025 and FDA regulations.

Waters 34 Maple StreetMilford MA 01757Tel: +1 508 478 2000 www.waters.com/informatics

Waters Informatics suite includes Empower Chromatography Software, NuGenesis SDMS and MassLynx Mass Spectrometry Software. The solutions help organisations reduce costs, accelerate decision making, and improve laboratory effectiveness.

ELNGuide pp01-40.indd 37 16/2/11 15:13:51


©2010 Waters Corporation. Waters and NuGenesis are registered trademarks of Waters Corporation. The Science of What's Possible is a trademark of Waters Corporation.

OnOnlyly W Wataterers s brbriningsgs t togogetheer ththe e popowewew r r ofo aa SScicienentiifi fic c DaDaDatata MManaanagaggememennt SySyststemem wwitith h h ththe e ecoconvnvenenieiencnce e ofof a an n e-e-LaL b b NoNoteteboookok. CuC t data pprocesss ining g ananand d rererepop rtrt wwriting ttimime e byby u up p too 9 999%9%..ReReduducece d datata a apapprprovovalal t timimeses bby y upup t to o 5050 – 75%. And seeamamlelessssly connnen ct everyy instrt ummmenentt inin yoyourur l labab.. BuBuyiyingng i it t wiwillll b be e the fi firsst ofof m manny y ququici k decisionons yoy u maakeke. BrBreae k througgh yoourur dadatata b bararririerers,s, a andnd v vieiew w ththe e latest ccasase e ststududieies s ata wata erers.com//sdsdmsms

Job #: WATR12530_A

Job Name: WATR12530_A_SDMS_DBmec.indd Date: 07-13-10Live: 6.75"x9.5" SmallTrim: 7.75"x10.5” LargeTrim: 8.375"x10.875" Bleed: 8.625"x11.375" Page: 1 Rev: 1Stage: mech Release: 07-13-10 DB AD: CP CW: GK PM: JT Scale: 100%Color: 4C Gutter: — Other: — ST: DB

MK: _____________ PM: ______________ AD: ______________

CW: _____________ QA: ______________ CD: ______________

Initials / Date Initials / Date Initials / Date

Client / Date: ________________________________

MECH

PROOF

AP

PR

OV

ALS

PUBS: American LaboratoryAmerican Drug DiscoveryAmerican Pharmaceutical ReviewBio BusinessBio IT WorldBioTech WorldBioTechnology FocusBioPharm InternationalBioProcess InternationalChemical & Engineering NewsDrug Discovery and DevDrug Discovery News

Environmental Science & TechnologyFood ProcessingFood QualityFood Safety MagazineGenetic Engineering News (GEN)Genome TechnologyGenomics & ProteomicsJour of The American Soc for Mass SpectrometryLab Asia Media GuideLab Business - JesmarLCGC AsiaLCGC N. America

LCGC EuropeMolecular and Cellular Protemomics Nature MethodsPharmaceutical Discovery & DevelopmentPharmaceutical ManufacturingPharmaceutical TechnologyPharmaceutical Technology EUROPEPharmaceutical ExecutivePharm Form and QualityProteomics JournalScientific Computing & InstrumentationScientific Computing World

Please note this is a COMMON SIZE mechanical file, you will need to center file using the center marks

provided when placing ad in the publication page area. (common size = smallest live/smallest trim / largest bleed)

� is guide, Getting started with an Electronic Laboratory Notebook, is written by John Trigg, and published jointly by Scienti� c Computing World magazine and phaseFour Informatics.

About Scientifi c Computing WorldNow in its 18th year of publication, Scienti� c Computing World is the only international publication dedicated to the computing and information technology needs of professionals working in science, technology, engineering, and medicine. Published in print and electronic media, it covers all aspects of computing focusing particularly on laboratory informatics, and computing in engineering, chemistry, physics, and life sciences.

Associated with the print magazine are: SCNewsline, a monthly e-mailed newsletter that keeps thousands of scientists and engineers in regular touch with breaking news in technology, research, and the business world as it a� ects scienti� c computing; and the website, www.scienti� c-computing.com, which carries web-exclusive material, including reviews of scienti� c so� ware.

About phaseFourphaseFour Informatics is an independent consulting practice, based in London, specialising in the electronic laboratory notebook and knowledge management market. Services are targeted at laboratories seeking to enhance performance by deploying strategic solutions to address technology, process and cultural requirements. Its services include:● Providing business justi� cations;● De� ning user requirements;● Preparing and reviewing RFPs;Addressing cultural and behavioural practices;● Preparing a strategy for a successful deployment;

and● Running short courses, seminars and workshops.

About the authorJohn Trigg is director of phaseFour Informatics. Previously, he was the IT manager for the Kodak European Research Laboratories. He has more than 20 years’ experience working in the � eld of R&D data, information and knowledge management, including 10 years’ experience of the world’s � rst enterprise-level implementation of an electronic lab notebook in the Eastman Kodak Company.

Trigg is author of a number of publications on electronic laboratory notebooks and knowledge management in the laboratory and has presented papers and run workshops at conferences in the UK, Ireland, Germany, USA and Australia. He is currently the chairman of the Automation and Analytical Management Group of the Royal Society of Chemistry. Trigg was the recipient of the 2000 International LIMS Award.

© 2011 Scienti� c Computing World and phaseFour Informatics

Scientifi c Computing WorldEuropa Science LtdThe Spectrum BuildingThe Michael Young CentrePurbeck RdCambridge CB2 8PD, UKEmail: [email protected]: +44 (0) 1223 211 188Fax: +44 (0) 1223 211 107www.scientifi c-computing.com

phaseFour InformaticsTel: +44 (0)20 8621 0389Email: john.trigg@phasefour-informatics.comwww.phasefour-informatics.com

ELNGuide pp01-40.indd 38 16/2/11 15:14:14

©2010 Waters Corporation. Waters and NuGenesis are registered trademarks of Waters Corporation. The Science of What's Possible is a trademark of Waters Corporation.

OnOnlyly W Wataterers s brbriningsgs t togogetheer ththe e popowewew r r ofo aa SScicienentiifi fic c DaDaDatata MManaanagaggememennt SySyststemem wwitith h h ththe e ecoconvnvenenieiencnce e ofof a an n e-e-LaL b b NoNoteteboookok. CuC t data pprocesss ining g ananand d rererepop rtrt wwriting ttimime e byby u up p too 9 999%9%..ReReduducece d datata a apapprprovovalal t timimeses bby y upup t to o 5050 – 75%. And seeamamlelessssly connnen ct everyy instrt ummmenentt inin yoyourur l labab.. BuBuyiyingng i it t wiwillll b be e the fi firsst ofof m manny y ququici k decisionons yoy u maakeke. BrBreae k througgh yoourur dadatata b bararririerers,s, a andnd v vieiew w ththe e latest ccasase e ststududieies s ata wata erers.com//sdsdmsms

Job #: WATR12530_A

Job Name: WATR12530_A_SDMS_DBmec.indd Date: 07-13-10Live: 6.75"x9.5" SmallTrim: 7.75"x10.5” LargeTrim: 8.375"x10.875" Bleed: 8.625"x11.375" Page: 1 Rev: 1Stage: mech Release: 07-13-10 DB AD: CP CW: GK PM: JT Scale: 100%Color: 4C Gutter: — Other: — ST: DB

MK: _____________ PM: ______________ AD: ______________

CW: _____________ QA: ______________ CD: ______________

Initials / Date Initials / Date Initials / Date

Client / Date: ________________________________

MECH

PROOF

AP

PR

OV

ALS

PUBS: American LaboratoryAmerican Drug DiscoveryAmerican Pharmaceutical ReviewBio BusinessBio IT WorldBioTech WorldBioTechnology FocusBioPharm InternationalBioProcess InternationalChemical & Engineering NewsDrug Discovery and DevDrug Discovery News

Environmental Science & TechnologyFood ProcessingFood QualityFood Safety MagazineGenetic Engineering News (GEN)Genome TechnologyGenomics & ProteomicsJour of The American Soc for Mass SpectrometryLab Asia Media GuideLab Business - JesmarLCGC AsiaLCGC N. America

LCGC EuropeMolecular and Cellular Protemomics Nature MethodsPharmaceutical Discovery & DevelopmentPharmaceutical ManufacturingPharmaceutical TechnologyPharmaceutical Technology EUROPEPharmaceutical ExecutivePharm Form and QualityProteomics JournalScientific Computing & InstrumentationScientific Computing World

Please note this is a COMMON SIZE mechanical file, you will need to center file using the center marks

provided when placing ad in the publication page area. (common size = smallest live/smallest trim / largest bleed)

ELNGuide pp01-40.indd 39 16/2/11 15:14:33

ELNGuide pp01-40.indd 40 16/2/11 15:14:35

Documents

Getting started with an Electronic Laboratory …accelrys.com/micro/notebook/documents/scw-eln-guide3.pdfGetting started with an Electronic Laboratory Notebook 7 It’s Time for a