ELN and the Paperless Lab


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“ELN and the Paperless Lab” is a 150 page collection of articles that cover a full range of topics, from explaining ELN basics to managing a successful ELN project. It answers the questions that are most important to anyone who is using, or considering using an ELN in a laboratory

The eBook is available for free download at http://www.labtronics.com/resources/nexxeln_ebook.asp

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ELN and the Paperless Lab

  1. 1. ELN and the Paperless Lab Inc.
  2. 2. ELN and The Paperless LabReproduction:You are free to copy, reproduce, and distribute this eBook by any means. You must give the originalauthor and publisher credit and you may not alter, transform or build upon this work.Legal Notice:The author and publisher of this eBook have used their best efforts in preparing this eBook. The authorand publisher make no representation or warranties with respect to the accuracy, applicability, fitness,or completeness of the contents of this eBook. The information contained in this eBook is strictly foreducational purposes. Therefore, if you wish to apply ideas contained in this eBook, you are taking fullresponsibility for your actions.The author and publisher disclaim any warranties (express or implied), merchantability, or fitness forany particular purpose. The author and publisher shall in no event be held liable to any party for anydirect, indirect, punitive, special, incidental or other consequential damages arising directly orindirectly from any use of this material, which is provided “as is”, and without warranties.Produced and Published by Labtronics Inc, 2011All rights reserved.Copyright 2011 ©Labtronics Inc Page | 2
  3. 3. Table of ContentsChapter 1: Introduction ......................................................................... 5Chapter 2: ELN Primer ........................................................................... 8 7 Great Reasons for Buying an ELN ................................................................................ 9 The Benefits of Making the Transition from Paper to an ELN ....................................... 12 A New Breed of Electronic Laboratory Notebook ......................................................... 16 Reduce the Cost of Data Quality .................................................................................. 19 Grow Green - the right choice for your business and the environment ........................ 22 The Benefits of Web-Based Applications for the Laboratory ........................................ 24 The Paperless Laboratory: Realities and Expectations .................................................. 26 Configuring an ELN for Routine Analyses ..................................................................... 31 Laboratory Resource Management - If it isn’t in real-time, when is it? ........................ 37 Why Doesn’t a Traditional Electronic Laboratory Notebook Work in a QA/QC Lab? ..... 40Chapter 3: Understanding the role of ELN in the Lab .......................... 44 The Automation Dilemma............................................................................................ 45 The Real Costs of Paper in the Laboratory ................................................................... 53 Laboratory Data - Safety, Security and Traceability ...................................................... 57 Go Paperless and Improve Procedural Execution ......................................................... 60 Keeping Tabs on the Lab - Real Time, On-line Management of Laboratory Workload .. 63 ELN Reduces Regulatory Compliance Costs .................................................................. 66 ELN Cures 4 Common Laboratory Headaches .............................................................. 69Chapter 4: Examples of ELN installations ............................................ 72 Automated Control and Documentation of Daily Calibration Requirements ................ 73 Error Free Preparation of Reagents ............................................................................. 75 Case Study: Rapid Deployment of an Integrated ELN/SDMS/LIMS Solution ................. 82Chapter 5: Instrument Integration ...................................................... 85 Page | 3
  4. 4. Application Note: Chromatography Workflow with Nexxis iLAB .................................. 86 Choosing the Right Balance Automation Solution ........................................................ 90Chapter 6: Managing and Planning ELN Projects ................................ 95 Case Study: Rapid Deployment of an iLAB (Integrated Laboratory) .............................. 96 Planning a Successful ELN Project ................................................................................ 99 Project Management – On Time and On Target ......................................................... 107 Paperless Automation Part 1 - Conservative Solution, Radical Technology ................ 111 Paperless Automation Part 2 - Right Down the Middle of the Road ........................... 114 Paperless Automation Part 3 – The “I want it all” Solution ......................................... 118 ELN Pilot Projects Pave the Way for the Paperless Lab............................................... 122Chapter 7: Legal and Regulatory Issues ............................................. 124 Don’t Hold Your Breath Waiting for a Test Case on Electronic Laboratory Notebook Records .....................................................................................................................125 ELN Meets 21 CFR Part 11 Compliance Requirements ...............................................129Chapter 8: ROI Calculator .................................................................. 132 Calculating ROI for an ELN Project ............................................................................. 133Chapter 9: Connectivity to other Lab Systems .................................. 137 LIMS and ELN: 1 + 1 = 3.............................................................................................. 138 What is an iLAB? ........................................................................................................ 141 Application Note: Environmental Monitoring with LimsLink and Nexxis iLAB ............. 147 Nexxis ELN and Nexxis CIM Integrate for Real-Time Chemical/Solution Management151 Page | 4
  5. 5. Chapter 1: IntroductionI have been involved with Labtronics Inc since its inception, 25 years ago. Initially the company focusedon interfacing instruments to LIMS and then expanded to interfacing any lab system. Over the last 5years we have also been involved in developing other types of laboratory informatics systems.For 25 years we have worked closely with developers of systems such as LIMS, SDMS and ELN, helpingthem interface their products to instruments and to each other. We have seen the market place fromthe point of view of the informatics systems developers and at the same time we have worked directlywith their customers giving us an understanding of their point of view. This has given us a uniqueinsight into this industry.It is a combination of this unique perspective and our realization that many people do not understandELN that led us to launch ThePaperlessLab.COM web site several years ago. This web site is filled withtechnical information that helps users to better understand the tools that can help them reduce oreliminate paper use in the lab. Much of the focus is directed on ELN.This year we decided to take this project one step further, by publishing this book.The purpose of this book, “ELN, and The paperless Lab” is to bring together some of the best articlesthat have been written about ELN in the last couple of years. This book will be a great reference bookfor anyone who is in the process of implementing an ELN or considering the implementation of an ELN.It will also be a good information resource for anyone who is interested in the automation of labs.This book is a collection of essays, each of which has been written to stand on their own as separatearticles. Rather than try and rewrite them to fit a standard book format, we have decided to leave eachone as originally written. You will find some overlap in topics, but this format will allow you to read theessays in any order that suits your needs.The Evolution of Electronic Laboratory NotebooksA very pragmatic view of ELN is that it is an electronic replacement for the old fashioned lab papernotebook. Wikipedia does not indicate when ELN was first invented but I suspect it was the early1990’s. By 2000, some commercial products were being offered and some early adopters wereimplementing ELN.In the next 5 years ELN started to become more prevalent. Companies were ‘test driving’ products togive the technology a limited try. Most of this activity was taking place in R&D labs. Page | 5
  6. 6. The initial driving force for ELN was to provide a better way to capture Intellectual Property (IP) andthe customers most interested in this were synthesis chemists working in pharmaceutical companies.Capturing discoveries for this group was a significant issue and the promise of a better, electronic way,to capture IP was very attractive. Synthesis chemists led the way.Initial commercial ELN products were very much geared to R&D work. What these customers requiredwas a secure way to ‘write’ out their experiments. The work that is done in R&D requires a system thatis very flexible – as flexible as a blank piece of paper. An ELN for R&D fulfills those requirements andalso prevents alternation of the data, incorporates electronic signatures to ensure proper tracking of IPinformation and provides better tools for data mining.In 2005 Labtronics Inc was the first company to release an ELN specifically designed for the QA/QCmarket place. To differentiate it from ‘R&D ELN’ it was given the product class designation “qELN”.Over the next 5 years the R&D ELN gained a solid foothold on the market place and many customershave adopted those products. Much slower growth was seen in the QA/QC labs. For them the conceptof an ELN is still very new today.The requirement for a QA/QC ELN is quite different than for an R&D ELN. The QA/QC lab is all aboutprocess control. Each analyst should be doing each test exactly the same way. “Flexibility” indocumenting work is just not acceptable. This is the main reason for the development of two distincttypes of ELN. These differences are further explored in some of the essays in this book. Understandingthe differences will help you to better understand your own requirements.In the last couple of years there has been an increase in interest for an ELN for biology andbiotechnology. This group also has special requirements. This ELN needs to be more flexible like theR&D ELN, but it also has to deal with more complex data such as DNA profiles.There are now some 30 different commercial ELN products on the market. With the exception of twocompanies who are focused on the QA/QC side, they all focus on R&D ELN.What do Customers Think?The above section is written from the perspective of a market analyst, but what does the customerthink?Atrium Research (Atrium Research & Consulting LLC) has done a number of surveys over the years andis a very good resource for more information. The 2010 Atrium report1 indicates that: - 47% of Biopharmaceutical organizations have at least 1 department using ELN - 18% of QA/QC labs make some use of ELN1 Atrium Research & Consulting LLC, “ 2010 Electronic Laboratory Notebook Survey” Page | 6
  7. 7. - 25% of the market knows little or nothing about ELN - 40% of the market understands the difference between ELN and LIMS (from 2008 study)These numbers confirm what we see in the market place. Much of the “talk” about using ELN isfocused on the R&D labs and ELN trade shows focus on R&D products. QA/QC labs are just nowstarting to consider ELN as a product for solving some of their issues. The essays in this book discussmany of these issues.For the most part customers are not clear about the role ELN, LIMS and SDMS play. Why is this?For one reason, most customers have never worked in a lab that has been automated with all threesystems. It is difficult to understand a system if you have never used it.Secondly, software developers are trying to be everything to everyone. A prospect commented to methat a leading R&D ELN developer had told them that their product would meet their LIMS needs. Thatstatement is not true. LIMS companies on the other hand are making significant claims about “ELNfunctionality” in their product. There is certainly some overlap when you compare ELN and LIMS, butrarely will one replace the other.It is important to understand the basic design of ELN, LIMS and SDMS and their specific purpose.Articles in this book will provide that information and once you understand the differences you will bein a better position to evaluate commercial products.The 2010 Atrium survey also measured ELN perceptions. Participants in the survey who had someinterest in ELN or who had used ELN were asked “What statements most closely matched your view ofan ELN”: - 42% said an ELN is a portal or entry point into all of the laboratories systems and databasesI find this surprising. As far as I know companies selling ELN do not position their product as a portalinto other labs systems. In fact most commercial ELN shy away from integrating their product intoother systems. The idea of using an ELN as a way to review results in LIMS or to view documents inSDMS is not practical, except in those cases where the ELN generated the data in the first place.The essays in this book will help clarify the role of ELN for your lab.Robert PavlisPresident, Labtronics Inc. Page | 7
  8. 8. Chapter 2: ELN Primer Page | 8
  9. 9. 7 Great Reasons for Buying an ELNHere’s a light-hearted list with 7 real life, day-to-day reasons for starting an ELN project. If your CFOhas a sense of humor, this just might work. If not, we have included a “translated” version of the listthat even the most tightfisted CFO, COO or CEO will want to buy into.Pick the list that works for you, sit down with “the boss” and get ready for big changes.Real-life Reasons for Buying an ELN 1. Calculators are passéIn a world where we can listen to music and surf the web on cell phones, do we really need to pull outa calculator to do the same routine calculations over and over again? Of course not, an ELN canautomate those calculations so that they are done the same way every time and nobody ever hits thewrong key by mistake. 2. Pens that work are in short supplyIt must be one of Murphy’s Laws that the first five pens you pick up when you need to write somethingdown quickly, either don’t work at all or leak ink all over the page so that nobody can tell what youwrote. Use an ELN to record your data electronically and forget all about trying to hang onto yourfavorite pen, the only one that works. 3. We need to save the treesNo kidding. By now everyone must realize that we need to start conserving our resources and one wayto do that is to cut down on the amount of paper we use. Replacing paper forms with an ELN at yourlab will make a contribution to that effort. Go Paperless – Save the World! 4. Where did all that leisure time go?In the 1950’s Popular Science promised us that the biggest problem technology would create would bewhat to do with our leisure time. It’s time for technology to deliver on that promise – use an ELN to getmore done in less time - and start planning your next vacation. 5. Repetitive Strain Injuries from entering test data into LIMSRepetitive Strain Injury (RSI) is caused by performing repetitive tasks, such as typing, writing, or clickinga mouse. Any kind of manual data entry is not only repetitive it’s also tedious, time-consuming, errorprone and downright boring. Let an ELN do that work for you. 6. Brown cardboard boxes are for moving day – not storing lab data Page | 9
  10. 10. Does it make sense to take all of your lab data, stuff it in a box and then lock it away, making it a choreto actually go back and see it again? An ELN can give you electronic on-line access to all that data andinformation and save you a ton of money on storage costs. 7. You would like to get through the year without someone asking for a sample result that was written on the page in your notebook where you spilled the coffee.Another one of Murphy’s Laws? The likelihood of a paper document or notebook getting lost ordamaged increases proportionally with the importance of the document. As soon as you see that cuptip over and your last three sips of “tall non-fat latte” splash across the page in your notebook – youknow that is going to be the sample, the test, the result that the auditor is going to want to look atduring your next FDA audit. Get an ELN that saves all your work as a PDF that can be stored andaccessed electronically – and you’ll never cry over spilt coffee again.Translation – Business Benefits of an ELN Project 1. An ELN automates manual calculations, reducing the amount of time analysts spend processing samples and giving them more time to run more samples. It also eliminates manual calculation errors, reducing time spent on secondary review, investigation and rework. 2. Legibility is always an issue with results that are hand written on paper documents – is that number an “8” a “3” or a “5”. Using an ELN to record data electronically eliminates time spent on secondary review and rework due to “legibility” issues. 3. Eliminating paper not only saves trees it eliminates costs associated with purchasing and storing paper supplies 4. An ELN applies the latest technology (web access, industry standard database platforms, etc) to provide faster access to data and information. Laboratory personnel don’t waste time trying to find the information they need, they are able to find the information they want, when they need it. 5. Eliminating manual keying of data delivers all of the benefits outlined in item #2, plus the added advantage of increasing employee job satisfaction by eliminating a tedious and time consuming task. 6. Long term on-site and off-site storage of paper forms and documents is costly and generates added cost and frustration when documents need to be retrieved for problem resolution or audit purposes. An ELN that saves completed forms as a PDF can replace costly physical storage with cost-effective electronic storage that can be quickly accessed. Page | 10
  11. 11. 7. Paper documents and forms are always at risk due to loss or damage. A simple spill or a careless misfiling of a document Free ROI Calculator for ELN can result in hours of time being wasted trying to find or Determine the real dollars and cents recreate test results. An ELN can remove that risk by storing value of an ELN project at your lab. field data from electronic worksheets in an industry standard database (SQL*Server or Oracle) and also storing an image of Click here to download. the completed forms and documents in a secure electronic environment. Page | 11
  12. 12. The Benefits of Making the Transitionfrom Paper to an ELNThe dependence of science on technology grows relentlessly. From the basic application ofcomputational power to undertake scientific calculations at unprecedented speeds, up to the currentsituation of extensive and sophisticated laboratory automation, black box measurement devices andmultiuser information management systems, technology is causing paper notebooks to becomeincreasingly rare in the laboratory landscape. Over approximately the last decade, paper hastransitioned from being the unchallenged archive medium for permanent records of scientificexperimentation, to becoming a convenient, portable but temporary medium for print-outs and oddnotes. In its place the Electronic Laboratory Notebook (ELN) is progressively taking over the role of thepreferred system for formal record keeping.But the ELN offers more than just a transition from paper-based working to electronic. The obviousbenefits are easier accessibility of information, search-ability, collaboration and sharing. Furthermore,taking paper out of the equation opens up the opportunity to progress towards a fully integratedelectronic laboratory, although the systems that we currently use in our laboratories are often a legacyof application-centric approaches that are based on the demands of specific laboratory technologiesand are limited by integration difficulties, incompatible file formats, and other technologicalinconsistencies. The benefits of the transition to an Electronic Laboratory Notebook seem to beobvious, but inevitably there are a number of factors to take into account such as costs, long termpreservation of electronic records, the acceptability of electronic records to support legal andregulatory compliance, and the ability and willingness of scientists to work electronically.The costs associated with the transition, and the return on investment will always be amongst theinitial, albeit short-term considerations in deploying an ELN. But the true value of the ELN may be longterm and therefore be far more difficult to measure since the value will be determined byunquantifiable benefits.There is a growing body of evidence being presented at conferences on Electronic LaboratoryNotebooks by companies that have implemented an ELN, showing that the short-term time savingsassociated with the electronic solution are significant. Astra Zeneca, Biovitrum and Eastman Kodak,amongst others, have all claimed time savings in the order of 10 -15%. But each of these organizationslists a number of other non-quantifiable, long-term benefits such as: Scientists can spend more time in the laboratory It is easier to find information in a searchable archive It is easier to share information Increased efficiency can be achieved through the elimination of paper – no more cutting, pasting, copying, filing, etc. Page | 12
  13. 13. There is a reduced need to repeat experiments (knowingly or unknowingly) Data quality (legibility) is improved A smooth transition when people leave the Company – their notebooks are readily accessible. On-line use in meetings – less need to prepare summaries, presentations, etc. when the notebooks can be viewed on-line.This demonstrates to a large extent where the true value lies; that a successful deployment of an ELNcan deliver long term benefits aligned to corporate business strategies. As IP protection, knowledgemanagement initiatives, sharing and collaboration rise higher on the corporate wish list, the limitationsof paper-based systems become increasingly exposed.It is interesting to look at non-laboratory areas that have undergone an analogue to digital transitionand to evaluate the benefits, or otherwise, of that transition. For example general communication,where email has replaced the traditional process of writing letters, putting them in an envelope,sticking on a stamp, and relying on a postal service to ensure delivery. Although there are some wellknown negative consequences of email, would we forsake the speed and convenience of electroniccommunication in order to revert to paper? Another example is digital photography; again, speed andconvenience are major benefits, relative to taking a roll of traditional film to a processing house forprints to be made, and then to return for additional copies if we wanted to share them, before, ofcourse, turning to the postal service again to facilitate delivery. In the case of digital photography, theability to capture and upload a photograph to an on-line repository and then share with friends andfamily anywhere in the world can take place in a matter of seconds.But back to the laboratory; what are the practical benefits of an ELN? Overall, the transition frompaper to ELNs offers benefits at two different levels, (a) in terms of business benefit, and (b) in terms ofpersonal productivity.For the business an ELN can bring about productivity and efficiency gains. Furthermore, thedevelopment of an accessible, searchable knowledge repository of scientific experimentation helpsresolve the Knowledge Management mantra ‘we don’t know what we know’. For multi-site,multinational operations, with the increasing need to share and collaborate with internal and withoutsourced functions, a central repository becomes increasingly important. This brings with it sometechnological challenges about controlled access and IP protection, but as the technology advances,these challenges are progressively being overcome.Personal productivity gains accrue from the elimination of certain paper-based tasks such as cutting,pasting, copying, filing, etc. These tasks can be replaced with more efficient electronic functions. Thishelps to save time, but it is important to remember that the documentation process itself may be noquicker; typing skills vs. writing skills can vary considerably from person to person. However, afrequently reported benefit of an electronic laboratory notebook is the use of ‘cloning’, basically,copying and editing an existing experiment where only detail changes need to be made. This has Page | 13
  14. 14. proved to be a very popular feature that can, in certain circumstances, bring about considerable timesavings.Another opportunity that ELNs offer in terms of productivity gains is the witnessing process, oftenconsidered a necessary chore, and one which doesn’t rank too highly on anyone’s priority list. Theweekly, or monthly, witnessing ‘party’ with paper lab notebooks is a direct response to overcomingthis lethargy. But this is another area in which technology delivers potential benefits through timelyand automated routing of witnessing requests and deadlines. The witnessing process can beconducted on-line using electronic/digital signatures, and followed up with reminders if no action hasbeen taken.The deployment of an ELN may be justified on measureable short-term gains in productivity, but thetrue benefit is likely to come from unquantifiable, anecdotal evidence from users as they recountinstances where access to the knowledge repository uncovers previously unknown information andidentifies others in the organization who have worked on the same or similar products, materials orservices. Through the initial phases of an ELN deployment, it is quite common to hear these stories,but over time, as this new way of working becomes the norm, the stories disappear. There’s an oldadage amongst scientists that a day or two in the laboratory can save an hour or two in the library.With the current levels of scrutiny of laboratory productivity, if the ‘hour or two’ in the library can bereduced to a few seconds for an on-line search, then benefits will accrue, not only from findinginformation quickly, but also in eliminating rework.Just going back to personal productivity, one of the interesting observations about ELN deployments ingeneral is the positive feedback from users about the operational aspects of the systems and thepersonal productivity benefits. This may be partly attributed to well-designed user interfaces and easeof use features, but can also be attributed to the care and attention taken by project teams to engage,encourage and support users through the requirements and deployment phases of the project.Derek Lowe, a medicinal chemist working on preclinical drug discovery in the US, wrote the followingin an article published in ‘Chemistry World’ 1: “The electronic lab notebook (ELN) has made me intowhat I never would have gotten around to becoming on my own: an organised scientist. Structures aredrawn on screen, stoichiometries adjusted, literature cited, reagents identified and sourced, theanalytical data attached and cross-referenced - oh, its something to see. And over the years, I wouldrather have eaten sand than do all that manually - and Id strongly consider ingesting a sand sandwichrather than go back to using paper now. The transition would be so painful that my documentationwould surely end up being even worse than before”. The quotation from Derek Lowe may seemoverwhelmingly positive, but it is not unusual to find this level of enthusiasm amongst users of ELNs.However, not all users will see it this way.We’ve talked about the benefits that an ELN can bring, but this is all subject to making the rightdecisions up front, and doing all of the ground work, with regard to change management from theperspective of technology, laboratory processes and preparing laboratory staff to adapt to the change. Page | 14
  15. 15. But furthermore, the laboratory is no longer an ivory tower; it is a critical element in the whole productlifecycle and forms an essential part of the overall workflow and information flow within theorganization. The acquisition and deployment of an ELN must take this into account, and consider notonly the functional requirements within the laboratory, but also consider how it will integrate withother corporate systems.The term ‘Electronic Laboratory Notebook’ is inherently ambiguous since it is far more than a directreplacement for a paper lab notebook. The mere fact that it is an electronic system will open upopportunities to seek a tight integration with other laboratory and corporate systems in order toextend the productivity benefits. This does raise some technology challenges, as the laboratory is notwell served in terms of data interchange and integration standards. Nevertheless, these challenges canbe overcome, but this is a factor that needs to be taken into account early in the requirements phase.In summary, the transition from a paper to an Electronic Laboratory Notebook is almost inevitable; thebenefits of electronic working, and the capability to meet organizational productivity objectives thoughsharing, collaboration and other process improvements are unachievable with a paper based system.The evidence from organizations that have already deployed an electronic laboratory notebookdemonstrates not only productivity gains, both at a corporate and personal level, but also points tounquantifiable benefits that can be accrued from having a shareable and searchable repository ofscientific experimentation.1 Derek Lowe, In the Pipeline, Chemistry World, April 2010, Available on line athttp://www.rsc.org/chemistryworld/Issues/2010/April/ColumnInpipeline.aspAbout the AuthorJohn Trigg is Founder and Director of phaseFour Informatics, a UK –based consultancy specializing inthe Electronic Laboratory Notebooks and laboratory integration. He has over 25 years’ experienceworking in the field of R&D data, information and knowledge management, including 10 yearsexperience of the world’s first enterprise level implementation of an Electronic Lab Notebook in theEastman Kodak Company. John is author of a number of publications on Electronic LaboratoryNotebooks and Knowledge Management in the Laboratory and has presented papers and runworkshops at conferences in the UK, Ireland, mainland Europe, USA and Australia. John is also thefounder of The Integrated Lab website. He was the recipient of the 2000 International LIMS Award andis currently the Chairman of the Automation and Analytical Management Group of the Royal Society ofChemistry. Page | 15
  16. 16. A New Breed of Electronic LaboratoryNotebookWhat is an Electronic Laboratory Notebook?The Collaborative Electronic Notebook Systems Association (CENSA) describes an Electronic LaboratoryNotebook (ELN) as follows:“An Electronic Notebook is a system to create, store, retrieve, and share fully electronic records in waysthat meet all legal, regulatory, technical and scientific requirements.”This is a very broad definition that can encompass a number of possible options. As a resultspecifications for an ELN can vary dramatically, making selecting an ELN quite difficult. In evaluating anELN it is important to consider your specific requirements.Is a blank page what you really want?When most people think of an ELN, they visualize an electronic version of a traditional laboratorynotebook where a screen displays the notebook, and allows the analyst to do anything that they coulddo in a paper notebook. The added benefit of an ELN is being able to electronically store and retrievethe pages in the notebook.In a purely R&D facility, this concept can work well. It is an advantage to have maximum flexibility – ablank page, if you like. As we move closer to a QC environment, the requirement for an ELN begins tochange. The freedom that is found in the R&D environment is no longer the norm.The ELN for a QC lab needs structure. There is a need to control the information that is recorded inorder to ensure that it meets requirements and standards. Unlike the R&D environment, it is notacceptable or desirable to record any observation or any data that the analyst feels is appropriate.Instead the requirement is for a much more controlled set of data. For example the data needs to beassociated with proper sample ID’s, and tests need to be carried out according to accepted procedures.The visualization of such an ELN is no longer a blank page, but well-defined forms, with rules applied tocontrol the analysis and the analyst. It is important when considering your ELN requirements tounderstand the kind of data that is being collected and the purpose for collecting the data.Leverage your existing data management capabilitiesThe definition for an ELN includes the need to “store, retrieve and share fully”. Everyone certainlyrequires this functionality, but does it need to be part of the ELN? For many laboratories, the ability to Page | 16
  17. 17. store the data in the ELN would be a duplication of the capabilities they currently have using theirexisting storage facilities.If a laboratory already has a LIMS, ERP or SDMS (scientific data management system), does it not makesense to use these applications to store the data produced by the ELN? These systems have alreadybeen designed and implemented for the purpose of storing and reporting laboratory data. Introducingan ELN with a separate data storage capability could be an unnecessary duplication of functionality. AnELN that can integrate with existing systems, leveraging their capabilities, is going to provide the mosteffective and productive use of resources.Nexxis ELN – A New Breed of ELNAs we have seen the definition of an ELN is very broad and no commercial ELN meets all of therequirements equally well. In selecting an ELN it is important to understand which functionality is mostimportant to your organization.Nexxis ELN is a powerful new breed of ELN that meets laboratory requirements in a way that isunmatched by any other solution. Using SOP management as its core component, Nexxis ELN allowsthe laboratory to create a structured data collection and information management environment that isbased on their established practices and procedures and is fully integrated with their existinginformation management systems.Structured Data CollectionAt the core of Nexxis ELN is the ability to automate and enforce the carrying out of analytical SOPs. ANexxis method not only guides the analyst through each step of the SOP, it also becomes a singleaccess point for all of the information resources required for monitoring and documenting the SOP.The Nexxis Method for a specific SOP can be designed to ensure that the proper instrumentation isused, that the instrumentation has been calibrated according to schedule, that only analysts that arefully qualified are performing the analysis, that analysts comments and observations are stored alongwith the data, and so on. The possibilities are endless because of the flexibility of Nexxis ReDItechnology.Integration with laboratory instrumentationNexxis ELN collects data directly from laboratory instruments, in real time, using a variety oftechnologies including PCs, tablets, notebooks, PDAs, wireless systems, etc.As Nexxis ELN guides the analyst through each step of the SOP, it also manages all communicationswith the instrument including sending commands to the instrument as well as collecting data.The sophistication and flexibility of Nexxis’ integration with laboratory instruments fully supports thestructured data collection environment created within the Nexxis method. Page | 17
  18. 18. Integration with Information Management SystemsUnlike other Electronic Laboratory Notebooks, Nexxis ELN is designed for maximum flexibility wheninterfacing with existing data storage applications such as LIMS, ERP and SDMS.This integration can be a two way street. Instead of viewing these systems as simply a place to storedata, Nexxis ELN can use them as a source of information that is critical to the SOP. Nexxis ELN canquery a LIMS for a worklist of samples that need to be run or automatically look up calibration recordsfor the instrument that is being used or even check results against a limits table for the analysis that isbeing run.A unique strength of Nexxis ELN is its ability to interact with a wide variety of existing systems and tofully incorporate those systems into the automation of the SOP – at the time of analysis.A Best of Breed SolutionNexxis ELN combines the most advanced technology for data collection and SOP automation with theability to integrate with existing LIMS, ERP and SDMS applications.The result is an Electronic Laboratory Notebook solution that integrates instrument data collection andanalysts input with laboratory procedures and systems within a controlled and automatedenvironment. Page | 18
  19. 19. Reduce the Cost of Data QualityIn today’s competitive and challenging economic climate laboratories face a real challenge as theybalance the need to maintain the high quality of the data that they produce while having to cope withthe necessity of keeping operating costs at a minimum.One way to address that challenge is by introducing automation and control over the everydaylaboratory tests that are carried out manually and recorded on paper forms or in notebooks.These paper based analyses depend on costly and time consuming manual review procedures andinvestigations to ensure data quality. With these manual procedures, errors are often caught after theanalysis is complete so there is also an added cost for rework that can be prevented if proceduralerrors and omissions are prevented at the time of analysis.In this article we will show how an Electronic Laboratory Notebook (ELN) for Routine Analyses meetsthe challenge of maintaining or even improving on the high level of quality that already exists whilereducing the cost of data quality on three fronts: 1. Reducing the amount of time spent on data review 2. Reducing the amount of rework that the laboratory needs to do 3. Reducing the amount of time spent on investigation and resolution when problems do occurSpend less time on reviewPaper-based, manual processes are inherently open to errors in data recording, calculations andtranscription. There is a rule of thumb in the industry that every level of manual data transcriptionincurs a 3% - 5% error rate. So the two simple steps of recording a sample result manually and thenkeying it into a software application like Excel or LIMS, will add a 6% - 10% margin of error to the data.Of course a 6% - 10% error rate is unacceptable, so laboratories need to carry out thorough multi-levelreviews to confirm the quality and accuracy of the manually recorded data. Each review takes time andoften requires a senior person, so there is a significant cost to the laboratory.Manual processes are also open to risk of error in procedural execution - forgetting to complete a stepin a process, using an instrument that hasn’t been calibrated, selecting a reagent that has expired, etc.Review processes also need to be in place to catch any actions, or lack of action, that may haveoccurred during the analysis that would affect the quality of the end results.Having to manage paper documents through a review process can be also be costly and be an exercisein frustration. File folders can get “lost” in somebody’s “In” tray. If a customer calls in to find out iftheir test results are ready, there can be a frantic search to see whose desk those results are on and if Page | 19
  20. 20. they have been approved or not. The amount of time spent on reviewing results can be extremelyinefficient simply because everything is recorded on paper.An ELN for Routine Analyses reduces the amount of review that laboratories need to conduct for theirroutine analyses and simplifies the process of carrying out the review. Automated data collection, calculations and recording eliminates manual errors and the need to review for manual errors “Right first time” procedural control ensures that SOP requirements are met every time eliminating the need to review for procedural errors On-line management of electronic documents eliminates “paper shuffle”, simplifying the review and approval processSpend less time on reworkWhenever the quality of a test result is in question, valuable personnel time has to be diverted awayfrom regular lab activity and over to determining the cause of the possible errors, correcting thesituation and rerunning the test. In addition to the time costs, the cost of any supplies that are used inthe process of the test (solutions, reagents, etc) is increased when samples need to be re-analyzed.As we have already seen, the automation and procedural controls that an ELN for Routine Analysesprovides are going to reduce the amount of rework that needs to be done by reducing the number oferrors that occur in the laboratory. In addition, speeding up the review and approval process bymanaging it on-line means that any problems that do occur are discovered sooner and rework isassigned faster.In addition to those two benefits, there is one more way that an ELN can speed up the rework processin order to reduce costs for the laboratory.For most routine analyses, the sample result from the test is expected to fall within certain limits ortest specifications. An ELN for Routine Analyses can apply those specifications to each sample result, asit is collected or calculated, to see if it is within specification.If a sample is out of specification it can be highlighted so that the analyst will know right away, at thebench level, that something needs to be done. They can then take immediate action to either rerun thesample or to ensure that all of the necessary materials are retained in order to facilitate a properinvestigation of the result.Reducing the possibility of errors, automating the process of identifying errors and speeding up theprocess of initiating rework are all benefits that an ELN for Routine Analyses can introduce to reducethe amount of time spent on rework and the cost of rework for a laboratory. Page | 20
  21. 21. Spend less time on problem resolutionWith all of the automation and control that an ELN for Routine Analyses can provide, there will befewer errors and problems for the laboratory to investigate and resolve, so less time will need to befocused on these activities. However, even in this controlled environment problems are going to occur.For example, an analysis may use a reagent that the laboratory purchases from an outside source. Thesupplier may discover that there is a problem with that reagent and send the laboratory notificationthat results for any tests that used that reagent may not be accurate. The laboratory then needs todetermine the scope of the problem - how many samples may have been affected, how many resultshave already been reported, etc.In this scenario an on-line, electronic system delivers significant benefits and cost savings over a paper-based system.Instead of having to search through boxes of documents that might be stacked away in a store room orat an offsite storage facility, one person can do a quick on-line search to find out exactly which samplesmay have been affected by the suspect material.The sheer speed and ease of searching electronically combined with the accuracy of an electronicsearch provides a clear advantage over searching manually.The laboratory spends less time identifying the extent of the problem allowing them to act quickly andeffectively to initiate an appropriate resolution for the problem.ConclusionLaboratories that use an ELN for Routine Analyses to transfer their paperbased processes into highly automated and controlled electronic Free ROI Calculator for ELNprocesses are able to spend less time on review, rework and problem Determine the real dollars and centsresolution without sacrificing the high standards of data quality that are value of an ELN project at your lab.critical to their success. Click here to download.Lowering the cost of quality can make the laboratory more profitableand more competitive by lowering their internal costs for each analysis.Spending less time on monitoring quality can increase laboratory sample handling capacity opening upopportunities to bring new clients on board while maintaining high standards of quality and service. Page | 21
  22. 22. Grow Green - the right choice for yourbusiness and the environmentDeciding to “grow green” - improving business capabilities while simultaneously making the rightenvironmental choices - is a choice that forward looking organizations are making in order to ensurelong term success and sustainability for both their business and for the world we live in.Laboratories that are currently using paper worksheets and SOPs to carry out their everyday routineanalyses can make the choice to “grow green” by transforming their paper based processes into online,electronic procedures that deliver real benefit to their business… Making them more efficient and more productive Reducing operating costs Increasing revenue and profitability… and also deliver a strong “green” advantage on a daily basis.How much paper can a laboratory save?At Labtronics we are working with a life sciences company that has selected Nexxis ELN to createelectronic versions of the paper forms and documents that they are currently using in their QAdepartment. Their decision to use Nexxis ELN is based primarily on the improved efficiency that theywill gain in workflow management, input validation and automated calculations and by having onlineaccess to their electronic forms rather than having to spend time searching for paper documents.However, they are also able to estimate the green advantage that an ELN will provide by reducingpaper usage.Their QA department performs approximately 12,000 tests a year and each of those tests uses a pre-printed form. The forms vary in size from one page to five pages, but in some cases they also attachprint outs of instrument data so the final data packet for a test could be up to 30 pages.On average a data packet is somewhere between 5 and 10 pages, so their estimate is that they willsave between 60,000 and 120,000 pages per year in that one department alone, by using ELN tomanage their test data and documentation electronically. Page | 22
  23. 23. What is the environmental impact of not using 100,000 pieces of paperper year?If you go on-line and type in the question “How many pieces of paper come out of one tree? “,onecommon answer is that 1 tree produces 8,333.3 sheets of paper. Using that number, we can calculatethat ELN saves approximately 12 trees every year – one tree every month, or 1 tree for every 1,000tests that they run.Saving twelve trees is a great step in the right direction for one department in one lab. If we multiplythat by all of the laboratories that use paper documents for routine testing on a daily basis, then wecan clearly see that there is a significant environmental advantage to having laboratories “gopaperless” for their routine analytical procedures.Grow Green, the right choiceTake the “green advantage” of reducing paper use. Add on the benefits of eliminating the costs ofpurchasing, managing and storing paper. Toss in the improvements in workflow management and testexecution. It all adds up to “growing green” as the right choice for your business and for theenvironment. Page | 23
  24. 24. The Benefits of Web-Based Applicationsfor the LaboratoryThe increased opportunity to use web-based applications brings significant benefits to a number ofwork environments including the laboratory. Primary among these benefits are issues related to theease of installation and validation; the advantages that the architecture of these applications provide;and the ability to potentially have multiple users access the applications from a variety of locations.Specific advantages are detailed below.Ease of DeploymentThe use of web-based applications significantly reduces client-side issues such as software deployment,management and updates. Installation is as simple as pointing the browser to a url. The client of web-based applications is always consistent across all of your workstations. No need for scheduling accesstimes to physical PCs and adjusting work schedules of users.Less ValidationValidation activity related to installation and operation can be significantly reduced as a result of theremoval of the requirement for individual physical installation processes on PCs. The absence of atraditional client application removes the requirement to spend time and resources testing the installof that client on individual PCs.Tiering of ComponentsConsider a traditional PC-based application that includes everything required to run (the user interface,data storage, business logic, etc.). This configuration can be viewed as single tiered or 1-Tier. Theprimary drawback of this approach is the lack of separation of components resulting in a lack ofscalability.A 2-tier architecture is essentially a terminal-to-server or browser-to-server environment. The clientusually handles the display, while the server handles the information storage. The business logic maybe handled in either or both of these levels. The basic model of a web server pushing pages to abrowser can be considered an example of 2-tier. This improves upon scalability, but still lacks a highdegree of separation of components thus restricting scalability.The typical approach today for business and web applications is a 3-tier architecture. In a typicalexample of the web browser acting as the client, an application server handles the business logic andthe database is managed in a separate tier. Page | 24
  25. 25. Breaking down the function of any of these tiers further leads to an n-tier environment, which furtherincreases the potential for easy scalability. It typically results in a more modular approach with thepotential to scale to your particular needs. A web-based application designed to be n-tier can be runfrom the full range of a single PC deployment, all the way up to a large-scale enterprise installation.Reduced Client Hardware RequirementsWeb-based applications have lower hardware requirements than locally installed programs. Since theapplication is run on a server, the users are not likely to encounter frustration related to anunderpowered PC running a traditional application.Multi-User EnvironmentsWeb-based applications by design are able to be accessed and used by multiple users from multiplephysical locations, all at the same time. Users simply need to be able to access the server resourcesover the network in order to launch and interact with the system.CentralizationAdministrative costs are reduced by centralizing data storage and administrative activity. Thisdecreases risks of data loss by users as a result of local PC activity (i.e. hard drive crashes and viruses).This also significantly improves aspects related to disaster recovery and business continuity planning.Use of Standardized TechnologiesSince web-applications are designed around web standards, training for both end users andadministrative members are simplified. In addition, the use of standardized technologies provides adegree of future-proofing the application over time as new operating systems and technologies arise.ConclusionApplications that are web-based have significant advantages over traditional standalone orclient/server applications. These advantages result in the savings of time and resources in today’sworkplace. Installation, administrative and management tasks are reduced through the use of thesetechnologies and architectures. Training and administrative tasks are also simplified. The centralizationof data storage saves administrative activity, related to backing up data and potentially restoringsystems. The use of web technology allows systems to be presented to users through a mechanismthat they are comfortable with – a web browser. Page | 25
  26. 26. The Paperless Laboratory: Realities andExpectationsIs it possible for a laboratory to become fully paperless with the technology available today? Theanswer is ‘yes’ – while the process may not be painless, it does offer tremendous improvements inboth the efficiency and quality of the data collected.Laboratories are highly automated, but much of that automation is in the form of instrumentation andinstrument data systems. When you look at the flow of information and the management of dailyactivities in laboratories, you quickly realize that much of this is still performed manually.The Laboratory Information Management System (LIMS) is the major system used to automate a lab,and its use is quite prevalent; it is used to track samples and their results, and can also be used toproduce a work list (although this is often produced as a printed report).The LIMS can also be used to receive sample results electronically from instruments. A recent surveyindicated, however, that although many companies may have a few instruments interfaced, very fewlabs have all of them interfaced and a significant number have no instruments integrated. Whereintegration does exist, it is usually fairly basic. Results are sent to the LIMS, but work lists are usuallynot sent to the instrument. The information collected is limited to what that specific instrumentproduces, and much of the associated metadata is missing.LIMS is not a particularly good tool for managing workflow in a laboratory. This may come as a surpriseto the reader, but LIMS has a fundamental limitation in its ability to control workflow. Since it wasoriginally designed to store sample information, it is not involved with the analyst at the bench level, inreal time, minute by minute. It does not control the testing or the analyst doing the testing, and as aresult the LIMS has limited control over workflow.Although instruments take centre-stage in a laboratory, the reality is that much of the work is stillmanual. Processes such as the preparation, weighing and movement of samples are usually all manual;taking measurements with simple instruments such as a pH meter, making reagents and making visualobservations are also manual. Many times, these manual steps use paper to both control the processand to collect data onto paper forms.WHY IS PAPER STILL SO PREVALENT?People like paper – they like to hold it and read it. There is some inherent comfort in creating paper –perhaps it makes us feel productive. It is also accepted that a signature or written sign-off somehowvalidates the data. Page | 26
  27. 27. Since existing procedures were specifically designed for paper, they also enforce the use of paper. It isinteresting to watch people move from paper procedures to electronic ones; they still want tomaintain their current procedure, even though it is not suitable for an electronic environment. To besuccessful, the procedure needs to be redesigned for the electronic system. This is time-consuming andcomplicated, and is one of the key reasons why people don’t automate.In general, laboratories use too many diverse software systems; in addition to the LIMS, there is theelectronic laboratory notebook (ELN), the scientific data management system (SDMS), the chemicalinventory, the training records module, the stats package and so on.Having all these systems is not a problem in itself; the real problem is that these systems do notfunction as one unit. There is no connectivity between them, and this means that manual paperprocedures are used to move data from the one to the other.The integration of systems is key to eliminating both manual procedures and paper.CAN A LABORATORY BECOME FULLY PAPERLESS?Tools are available today to remove at least 95 per cent of the paper in a laboratory. In order toachieve this, it requires a change in procedures and a high level of integration between systems.The following simple principles must guide the change: No piece of information should be entered more than once No piece of data should be written; it must be entered directly into a software system Data already in a system needs to be readily available, where and when it is neededTake the simple example of an ELN and a LIMS. Typically these are two separate systems, and in orderfor data to go from one to the other it must be manually transcribed. This dramatically reduces thevalue of the two automated systems.Following the above principles we can see how LIMS, ELN and other informatics systems can interactwithout using paper or manual processes: Sample information in LIMS must be available when it is needed in the ELN Results are recorded once in the ELN, and then automatically transferred to LIMS ELN, should be able to connect to the training module, check the analyst’s training records and prevent them from proceeding if they don’t have the correct level of training Training information – such as date of training and version of course – should be automatically added to the collected data as metadata. Page | 27
  28. 28. ELN should also be able to interact with other systems such as chemical inventory and instrument calibrations in the same way Completed ELN worksheets should be saved electronically (PDF) and sent to SDMS for long- term storage of the raw data. Sample results in LIMS should include a direct link to the raw data in the SDMS so that it is easy to look up the information.Integration is the key to making this happen. Each system operates as an independent application –but when integration is complete, they function as though they were one system, eliminating manualsteps and the need for paper.Is this integration available today?The answer is ‘yes’ – but only indirectly. The individual systems have not been designed to work wellwith each other. There are no integration standards and, despite the efforts of a number of groupsover the last 15 years, no standards are expected in the near future.The solution is to use a third-party integration tool, like LimsLink, that is configurable, generic and ableto integrate just about any system.Using LimsLink allows laboratories to continue to select ‘best of breed’ products for each applicationwith the understanding that LimsLink will be able to provide the integration with other systems.Laboratories also have the flexibility of replacing or updating one application without affecting theintegrity of the whole system.With LimsLink providing the integration between systems, there is no technological reason why thewhole process of managing samples and generating results cannot be paperless.WHAT ABOUT WORKFLOW CONTROL?Workflow control can be divided into two different processes: control of the individual analyst andcontrol of the laboratory as a whole.Workflow control of the individual analyst requires that a system control their every action on aminute-by minute basis. The system should be sophisticated enough to prevent the analyst frommaking a mistake. This can only be accomplished by a system working at the bench level, in real time,as the analyst is performing their job.The goal is to eliminate any variation from analyst to analyst, and this cannot be accomplished if thereis paper involved in the process. Everything needs to be electronic and automated. Page | 28
  29. 29. Each step of the analysis process needs to be controlled, and this control needs to be automatic and –for the most part - transparent to the user. Examples of having full control over the individual analystand the process include being able to: Validate the correctness of the data in real time Check training records before the procedure is started to ensure that the analyst has been trained. Check that the selected instrument is calibrated Confirm that the selected batch of reagent has not expiredThis functionality is available in Nexxis ELN, an ELN for the QA/QC lab that controls both the test that isbeing run and each individual step in the test. With Nexxis ELN, the technology exists today to make allof this possible. Once implemented, the whole process becomes paperless.But what about workflow control of the whole lab? Can it be a paperless process?Workflow control of the whole lab deals mostly with scheduling and allocation of resources – bothequipment and human. Many systems claim to have ‘workflow management’ capabilities, and they doprovide some aspect of the functionality – but despite these claims, true workflow management doesnot exist as a commercial offering. Until it does, labs will not be completely paperless.SO WHAT IS COMING DOWN THE PIPELINE?Perhaps the most interesting development in the last couple of years has been the introduction of anew type of laboratory system called an iLAB or Integrated Lab. This system is a total lab solution thatenhances existing systems, like LIMS and chromatography data systems (CDS), by integrating them andadding missing functionality such as real-time workflow control. The system works at both the benchlevel and the lab level, giving it the potential to provide complete workflow control in the future.For the analyst, the iLAB functions in a similar way to Microsoft Outlook. It provides a work schedule,messaging system and planner, as well as a simple way to access the various applications operating inthe lab. It becomes the analyst’s dashboard and access point to their work, providing easy access tothe LIMS, ELN, SDMS and CDS at the same time.For the manager, iLAB provides a control and real-time monitoring system for the whole lab. Aresource shortage is easily identified; approaching deadlines are highlighted; resources arerescheduled as needed; and problems in the lab are automatically flagged so that immediate correctiveaction can be taken.With the introduction of the iLAB the possibility of a paperless lab has taken a huge step forward. Thekey is the ability to integrate independent applications into a single system that provides real-time Page | 29
  30. 30. automation and control at every level in the laboratory, eliminating manual processes and the paperwork that goes with them.The process of going paperless still won’t be painless – but it will deliver tremendous improvements inboth the efficiency of the laboratory and the quality of the data collected. Page | 30
  31. 31. Configuring an ELN for Routine AnalysesIn laboratories that are performing routine analyses on a regular and on-going basis, there are realadvantages to having an ELN that simply records results and observations. Even more benefit can bedelivered to the laboratory by expanding the role of the ELN, making it a pro-active componentcontrolling the analytical process and ensuring that every aspect of an SOP is being fulfilled.In this article we will take a step by step approach to configuring an electronic laboratory notebook,starting with the most basic implementation and then showing the additional layers of automation,logic and control that can be applied and the additional benefits that are introduced at each step of theway.Step 1 – Start by Eliminating the PaperThe most basic goal of an ELN for Routine Analysis is to move from paper based systems to electronicsystems. So we can start by simply doing that, taking existing paper worksheets, documents or SOPsthat are used on a regular basis and creating simple electronic versions that can be managed by theELN.It’s a real eye-opener to see how much benefit can be delivered by taking that first step and removingthe costs and inefficiencies associated with managing paper.Eliminate illegibility problems created by hard to read manual datarecordingAn immediate advantage for even the simplest electronic worksheet is that you completely eliminatethe problem of having to decipher results that are hard to read because of illegible handwriting. Asimple electronic worksheet that lets analysts key in results, eliminates any doubts surrounding“legibility”Eliminate problems due to lost or damaged paper formsPaper forms and note books are extremely vulnerable to being misplaced or exposed to all kinds ofdamage in the laboratory environment. With a simple electronic form we can quickly eliminate thosepossibilities.Simplify management of the worksheet lifecycleEven if we assume that paper worksheets never get lost or damaged, we still need to deal withphysically moving the paper through the cycle of scheduling, monitoring and reviewing completedworksheets. Knowing where a certain worksheet is in that process can be a real challenge when youare dealing with paper. Page | 31
  32. 32. Eliminate paper storage and retrieval costsMoving from paper to electronic documents not only saves on physical storage costs, it also reducesdocument retrieval time with direct on-line access to completed worksheets.Provide better access to dataWith a paper system, when you finish your testing you still have a lot of work to do to make that dataavailable within the organization. Even a simple electronic worksheet can be setup to store results in adatabase, where it is immediately accessible and ready to use.So you can see that simply moving from paper to electronic documents delivers real and significantadvantages by increasing confidence in the data that is reported, simplifying management processes,reducing storage and retrieval costs and providing better access to data.Step 2 - Add automated data collection, calculations and limit checksWith a simple, basic electronic worksheet in place, we continue to configure our ELN by addingautomation capabilities that deliver added value when executing routine analyses.Collect data directly from instrumentsThe simple worksheets that we have discussed so far have depended on the analyst to key in testresults, which is an improvement over writing them down on a piece of paper but it is still a processthat is open to error.There is a rule of thumb in the industry that every level of transcription Nexxis ELN includes anincurs a 3 – 5% error rate. We can eliminate that possibility for error by Instrument Library that simplifiesconnecting with the lab instruments and collecting data directly from data collection from over 400 ofthe instruments right into the electronic worksheet. the most popular laboratoryInstead of manually entering results, analysts can automatically collect instruments.and record data with a single click of a button.With that one additional layer of automation we ensure that the data generated by the instrument isthe same data that is recorded in the worksheet, each and every time.Automate calculations to ensure consistency and accuracyOnce the data has been automatically collected into the worksheet, it makes sense to automate themanual calculations that the analyst may need to do in order to produce a reportable result. These caninclude weight corrections, applying dilution factors, averaging of results and so on.Our users have told us that if there is one place in the lab where mistakes occur on a regular basis it iswith manual calculations and that significant time needs to be spent checking and correctingcalculation errors. When we automate these functions for them in the electronic worksheet, they not Page | 32
  33. 33. only save time for the analyst, they also get a 100% reduction in calculation errors and get back thetime that is being spent reviewing the manual calculations.They now have a consistent, accurate and documented process for calculations - that is being appliedeach and every time.Automate limit checksA result that comes directly from an instrument or that is the result of an automated calculation isusually expected to fall within certain limits or test specifications.Another layer of automation that we can build into our ELN is to apply those specifications to eachsample result, as it is collected or calculated, to see if it is within expected limits.If a sample is out of limits, it can be highlighted so that the analyst will know right away, at the benchlevel, if a sample fails the limit check. They can then take immediate action to either rerun the sampleor to ensure that all of the necessary materials are retained in order to facilitate a proper investigationof the result.Figure 1 Automate limit checks so analysts know right away if samples are out of specificationThat completes the next step in configuring our ELN for routine analysis, taking the simple electronicworksheet that we started with and adding automation that reduces analysts’ workload and increasesthe consistency and quality of the process, by automating basic day to day data managementfunctions.Step 3 - Provide step-by-step control over execution of the SOPThe next step in configuring an ELN for Routine Analyses is to add a layer of logic to control completionof the electronic worksheet.In an environment where you are executing routine tests on a repeated basis, an ELN can be used tocreate a very controlled environment that ensures that every aspect of an SOP is being followed andthat procedures are carried out the same way, every time. Page | 33
  34. 34. Use Logon ID to control access to worksheetsWe can start by controlling access to the electronic worksheets based on the user that has logged ontothe system. Analysts can be limited to only working with worksheets that they are authorized to workwith. If an analyst isn’t authorized to run a certain test, then that analyst won’t have access to theworksheet for that test.Assign specific instruments to specific testsWe can also apply the same principle to equipment and instrumentation that is used in the analyticalprocess. Electronic worksheets can be associated with specific pieces of equipment in the lab thatmeet the requirements of the SOP. If a weighing application requires a balance that weighs to 5decimal places then the worksheet can be setup to only allow analysts to use balances that meet thatrequirement. Figure 2: Analysts can select from a drop down list of balances that meet the requirements of the SOP.Ensure that each step in the SOP is completed correctly before continuingThe worksheet can also be setup to provide step by step access to the procedure, only allowing theanalyst to move to the next step if they have fully and accurately completed all the requirements forthe current step.For example, in Fig 2 you can see that an error message has been generated because the analyst triedto take a pH reading for the first buffer without entering a buffer Lot number. You can also see that theanalyst can’t proceed to take a reading from the next buffer until the first reading has beensuccessfully completed.Figure 3 Warning messages ensure that analysts follow SOP requirements Page | 34
  35. 35. Include conditional branches (calibration, out-of specification)Logical controls can also be incorporated into the electronic worksheet so that if a particular conditionoccurs (an instrument needs to be calibrated or a result is out of specification) the worksheet canbranch to a path that takes the analyst through the right steps to follow for that condition.For example if a balance needs to be calibrated, the ELN worksheet can automatically branch to acalibration procedure that needs to be successfully completed before continuing with the analysis.Real time control over the execution of the analysis ensures that the SOP is followed, each and everytime.Step 4 - Create a fully integrated informatics infrastructureWe have one more layer to add before we finish configuring our ELN for Routine analyses – connectingthe ELN with other laboratory systems.One of the strong advantages that we have seen of moving from paper to PC is that electronic data ismore accessible. So it makes perfect sense to share data and information between the ELN and yourother applications.Instead of making analysts access a number of different applications to retrieve the information theyneed or to update applications, a fully integrated informatics infrastructure delivers information to theanalyst and automatically updates other applications as work in the ELN is completed.Connect with LIMS…An obvious and common example is to automatically send sample results from the ELN to LIMS. Butthat is only half of the equation.LIMS stores sample information, results from other tests, limit tables, etc, that is important to theanalytical process. Rather than have the analysts looking up this information it is more efficient to havethe ELN automatically retrieve this information from LIMS and deliver it to the analyst as they aredoing the analysis.The exchange of data between the ELN and other systems is best if it is a two way exchange and if ittakes place in real time at the point of analysis.Connect with inventory management…Another good example of two way information exchange is to have the ELN worksheet interact with aninventory management system.The worksheet can be setup to collect information from a bar code on the container of a solution thatis being used in a step of the worksheet. Page | 35
  36. 36. The ELN can use that information to query an inventory system to confirm, right then and there, thatthe solution is the right one for that step and that it has not passed its expiry date. When the step hassuccessfully completed, the ELN can automatically update the inventory to reflect the amount ofsolution that was used in that step.Connect with any informatics application…That principle of real time integration can be applied to the automated transfer of information backand forth between the ELN and virtually any informatics application (calibration management, trainingrecords, etc).A fully integrated informatics infrastructure ensures that the information contained in all of yoursystems is automatically included and updated as analyses are carried out.Configuring an ELN for Routine Analyses – step by stepWe have seen how an ELN for Routine Analysis can deliver immediate benefit by simply eliminatingpaper and then be built up from that point to include automation of manual tasks, control over SOPrequirements and integration with other informatics applications, delivering increasing benefits ateach step of the way.A properly selected ELN will allow you to select where in that process you want to start with theimplementation. It will let you convert paper worksheets into simple electronic documents as astarting phase and then add automated data collection and calculations as needed.When all of the automation has been added the result is a sophisticated electronic laboratorynotebook that transforms paper based manual analyses into electronic processes that are fullyintegrated into the day to day operation of the laboratory. Page | 36
  37. 37. Laboratory Resource Management - If itisn’t in real-time, when is it?Management of laboratory resources (i.e. personnel, inventory and instrumentation) has developed intwo directions - paper based systems and electronic systems (spreadsheets, stand-alone applications,LIMS modules). Both systems are used to record and store information regarding resource suitability,availability and usage.Both of these approaches suffer from two inherent drawbacks:1. They are open to inaccuracies due to errors and omissions because they depend on laboratory personnel to manually keep them up to date and accurate.2. They are not able to control resource use because they are not directly connected with the activities in the laboratory that use resources.In this article we will see how both of these drawbacks can be eliminated through real-time, eventdriven integration of resource management with laboratory activities.What is real-time, event driven integration?In the context of laboratory informatics, real-time, event driven integration refers to the ability totransfer information between two separate processes or applications - at precisely the time that theinformation is needed or generated. A specific event is used to identify exactly when the transfer ofinformation should take place.A simple example is that of using an interfacing solution like LimsLink to transfer data from alaboratory instrument to a LIMS. As soon as the instrument creates a result, LimsLink captures thatresult and transfers it to LIMS. The integration is driven by a specific event (generation of the result)and it is happening in real-time (as soon as the result is available).How does that get applied to resource management?As we mentioned earlier there are two drawbacks to resource management that want to resolve. Wewant to be able to control the use of resources and we want to be sure that the information we haveabout resources is always accurate and up to date. So there are two points, where we can apply real-time, event driven integration - when resources need to be used and when resources are created orupdated. Page | 37
  38. 38. ExampleA chemist needs to weigh out 5 grams of chemical A. To do that the chemist needs to use tworesources - a balance and chemical A.Without real-time event driven integration, the chemist needs to take a number of manual steps inorder to make sure that these two resources are available and suitable - does the balance meet theprecision requirements of the SOP, has the balance been calibrated, is the material that they have intheir hand actually chemical A and is it within its expiry date?Most of the time, those checks will be done and done correctly. But because they are manualprocesses, there will be occasion when errors and omissions will occur.With real-time, event driven integration that single event - the need to weigh 5 grams of chemical A -will initiate real-time integration with two applications. There will be an automatic check with thecalibration management application to confirm that the balance has been calibrated and that it meetsthe SOP requirements. There will also be an automated check with the inventory managementapplication to confirm the suitability and availability of chemical A.The next event, actually weighing out the material, provides another opportunity for real-timeintegration. Instead of depending on the analyst to subtract the 5 grams of chemical A from inventory,we can use real-time integration to automatically adjust the inventory level.When a resource is needed - real-time, event driven integration can automatically check to see if it isavailable and if it meets the requirements for the procedure (is the analyst fully trained, is theinstrument calibrated, is the chemical within its expiry date).When a resource is used or created - real-time, event driven integration can automatically update theapplication managing that resource (record completion of training, record calibration of instrument,adjust inventory levels)How do you create real time, event driven resource management?The very first step in creating real-time, event driven resource management is to get rid of paper.Paper based systems can’t be automated and they can’t talk to each other.Your resource management applications (training, inventory, calibration) need to move from paper (orspreadsheets) to database applications that can be queried and updated in real time. This can be donewithin LIMS or using stand-alone applications. The key is that these applications need to be able tocommunicate with other applications. Page | 38
  39. 39. You also need to transform the many resource intensive activities in the laboratory, like samplepreparation, that are paper based. An Electronic Laboratory Notebook (ELN) can replace that paperwith electronic forms that control the step by step execution of the procedure and communicate withother applications, as the procedure is being carried out. With the paper gone, the ELN becomes thefocal point for real-time, event driven resource management.Every time an event in a process uses a resource, the ELN can confirm with the appropriate resourcemanagement application that the resource is available and meets the SOP requirements. Every time aresource is used or created, the ELN can automatically update the appropriate resource manager.What are the benefits of real-time, event driven resource management?At the beginning of this article we identified two significant drawbacks to most resource managementsystems - inaccuracies due to errors and omissions in manual processes and lack of control over theuse of resources.The process we have described for implementing real-time, event driven resource managementintroduces real benefits for the laboratory by overcoming those drawbacks: Mistakes are caught before they happen o Availability and suitability of resources is confirmed before they are used Resource information is always accurate and up to date o Event driven automation removes the human factor from resource management Reduced overhead for analysts o Manual tasks are taken away giving them more time to focus on execution Documentation is quickly and easily available electronically for investigation, audit or inspection o Electronic forms are stored in SDMSA totally integrated lab solution can provide these benefits today. Page | 39
  40. 40. Why Doesn’t a Traditional ElectronicLaboratory Notebook Work in a QA/QCLab?Historically, Electronic Laboratory Notebooks have been designed to accommodate researchlaboratories. Little, if any, consideration has been given to the needs of QA/QC labs. However, therequirements of QA/QC labs are significantly different from research labs. This article will discuss thesedifferences and identify the requirements of an ELN for the QA/QC lab.R&D RequirementsThe traditional view of an ELN is that it is an R&D tool. It provides three main functions to the R&D lab: A means to document and protect intellectual property and meet legal requirements for patenting new discoveries Documentation throughout the discovery process to meet regulatory requirements A collaboration platform so that scientists can share their research with their colleaguesIn an R&D environment the ideal ELN is one that provides the most flexibility and freedom for theresearcher – a blank page that allows the researcher to do anything that they would in a papernotebook. The researcher should be able to record data, make observations, describe procedures andinclude images, drawings and diagrams.All information related to their research should be stored electronically in a format that allows for easyretrieval and sharing with other researchers. The format also needs to be flexible enough to adapt tochanging requirements as the research program moves through successive stages.QA/AC RequirementsThe requirements for an ELN are quite different in a QA/QC environment. Quality Departmentstypically conduct routine tests. They, therefore, need a structured environment to ensure that theyconduct these tests the same way every time. To do this they use worksheets and/or StandardOperating Procedures to help guide the analysts through the testing process. Page | 40
  41. 41. Sample of a paper worksheet converted to an electronic spreadsheetAn ELN for the QA/QC lab should create an electronic version of your existing worksheet. An ELNshould not dictate how you do business; it should just help you to get it done more efficiently andeffectively.The freedom and flexibility that is found in the R&D lab gives way to the need in the QA/QC lab tocontrol the information that is recorded, in order to ensure that it provides a consistent and accuratebase for monitoring production quality. This requires a more structured environment for datacollection that ensures analysts adhere to established SOPs laid out in the worksheet.Once the worksheet is completed it typically needs to be approved and in many cases that approvalprocess is multi-layered. An ELN can help to manage and expedite that approval process to ensure it isfollowed and completed without anyone having to track down a paper worksheet.The data that is collected in the QA lab must be available to existing systems such as LaboratoryInformation Management Systems (LIMS), Process Information Management Systems (PIMS), andEnterprise Resource Planning (ERP) systems such as SAP. All of this must be accomplished in anenvironment that fully meets the laboratory and regulatory security requirements.Based on the requirements we have identified for the R&D lab versus the QA/QC lab it is easy to seewhy a traditional ELN that has been developed for an R&D lab does not satisfy the needs of a QA/QClab. The remainder of this article will focus on providing an overview of how an ELN can be designed toaccommodate the needs of the Quality Department.A Structured Environment for Data CollectionThe starting point for creating a structured environment for data collection is to eliminate manualtranscription of data. Automatically collecting data directly from the instruments ensures that the datagenerated by the samples is the data that is recorded in the ELN. There is no room in the QA/QC lab forinaccurate or inconsistent data that is the result of manual data collection and entry errors. Page | 41
  42. 42. An ELN that automatically collects data directly from your instruments provides many benefits: Eliminate manual data entry Reduce transcription errors Automate calculations Ensure data falls within specified limitsAutomate and Control the SOPIn a QA/QC lab Standard Operating Procedures are developed to ensure the accuracy and consistencyof sample data. It is essential that these procedures be followed exactly, for each and every analysis. Ifa sample result is out of range the lab knows that it is because of something in the sample and not inthe way it was analyzed.Ensuring that an SOP is being followed means monitoring and controlling all the parameters involved inthe analysis including: Ensuring the appropriate instrumentation is being used to conduct the test Ensuring instrumentation has been properly calibrated Verifying the analyst is qualified to conduct the test Controlling the execution of each specific step of the procedureAutomating the worksheet ensures full control and documentation of every aspect of the analysis.Integrate With Existing SystemsFor many QA/QC laboratories, being able to store data in the ELN would be a duplication of thecapabilities they currently have with their existing storage facilities.If a laboratory already has a LIMS, ERP or other data management system, it makes sense to use theseapplications to store the data collected by the ELN. An ELN that can integrate with these systems willprovide the most effective and productive use of existing resources.Not only should an ELN be able to store data in these systems, the ELN should also use them as asource of information that is critical to the SOP. The ELN can query a LIMS for a worklist of samplesthat need to be run, or automatically look up calibration records for the instrument that is being used,or even check sample results against a table of limits for the analysis that is being run.The ability to interact with a wide variety of existing systems and to fully incorporate those systemsinto the automation of the SOP leverages your current investment in technologies. Page | 42
  43. 43. Meet Security RequirementsData security and regulatory compliance are important issues for any QA/QC laboratory. Put quitesimply, data that is captured electronically must be protected from any possible means of corruption atany point in the creation, collection and reporting system.Password protection, electronic signatures, audit trails and archiving are all components that can beimplemented to provide the level of security that meets regulatory compliance requirements.An ELN for the QA/QC LabThis article has discussed how the requirements for an ELN in a quality environment are quite differentthan those in R&D. QA/QC labs have routine tests that they conduct using standard worksheets. AnELN needs to automate those existing worksheets to make it easy for analysts to use.In the QA/QC lab, the need for freedom and flexibility found in the R&D lab is replaced by a need forstructure and control.An ELN that uses instrument interfacing and SOP and approval process management as its corecomponents can meet QA/QC laboratory requirements in a way that is unmatched by any othersolution. This solution allows the laboratory to create a secure, structured data collection andinformation management environment that is based on their established practices and procedures andis fully integrated with their existing information management systems. Page | 43
  44. 44. Chapter 3: Understanding the role of ELNin the Lab Page | 44
  45. 45. The Automation DilemmaThe automation dilemma exists between customers and vendors. The customer understands theirbusiness and the specific problem that they need to solve, but they don’t fully understand the best wayto use available technology to solve the problems. In fairness to the customer it is always hard tovisualize a solution without seeing it. The vendor understands the technology and knows how to solveproblems with their products. Unfortunately they really don’t understand the specific problems of acustomer.This is the automation dilemma; two parties who do not really understand each other’s problems andsolutions.The Laboratory Automation Plan (LAP)In an effort to solve the automation dilemma, Labtronics Inc developed the Laboratory AutomationPlan (LAP). This plan follows a 4 step process: Step 1. Labtronics engineers perform a site visit so that they can see the lab workflow first hand. They interview management to better understand the key problem areas of the business. They also spend time with the analysts to get a detailed understanding of the workflow and the processes used. Step 2. Labtronics uses the information gained to develop a detailed analysis of the workflow, identifying bottlenecks and areas which could be improved by automation. Step 3. Labtronics develops a detailed automation plan to solve the key problems Step 4. Labtronics and the customer review the plan so that there is full understanding on both sides of the table.To better understand the benefits of a Laboratory Automation Plan it is instructional to examine one inmore detail. The following description uses examples from an actual LAP with some of the nameschanged to protect the confidentiality of the client.The ProblemsThis client is a service testing laboratory that approached Labtronics with a couple of general problems.Firstly, they had a centralized LIMS that tracked results, but most of the analytical data resided onpaper in a number of satellite labs. Reviewing any data except final results was a very laboriousprocess.Secondly, they felt that they should be able to improve operational efficiency by eliminating some ofthe paper currently being used in their processes. Page | 45