Scientists have traditionally used paper notebooks to keeptrack of their experimental ideas, observations and researchresults. Maintenance of accurate records of the experi-ments performed is an important aspect of all laboratorywork. Among scientific documentation, the laboratorynotebook is the most prominent, being the official recordof laboratory measurements and observations. For theresearcher, a properly maintained notebook can be a sourceof useful information for many years. For a scientific orga-nization, lab notebooks are a potential goldmine of knowl-edge and experience. Enabling electronic access to labnotebook data might greatly improve knowledge manage-ment capabilities, eliminate the waste of information thatis inherent in the paper system and improve efficiency byhelping to reduce work duplication.

After the rapid adoption of digital technologies duringthe last decade it might appear a curiosity that paper labnotebooks still persist. The main reasons for this are thatlaboratory notebooks can contain important legal infor-mation related to priority of patent claims, as well asverification of compliance with regulations such as GxP.A precondition for shifting towards electronic laboratorynotebooks (ELNs) is that the new medium must be ac-ceptable in all legal proceedings. This has so far not beenproven in practice, causing many initial ELN initiativesto stall.

In reality, the adoption of electronic media for labora-tory notebooks is not a revolutionary change, but an evo-lutionary process that has been going on for some time.Think for a moment about just how ‘paper’ your lab note-book of today really is. Looking around your lab, what doyou see? For over a decade now, almost all modern labinstruments have been producing digital output. Eventraditionally low-tech devices such as balances have beenconnected to computers. And can you even think of pro-ducing a chart without using spreadsheet software?

As a result, you have been literally cutting and pastingthese computer printouts. An unscientific poll in our or-ganization showed that, depending on the area of re-search, pasted printouts constituted 25% to 80% of all labnotebook content. The latter notebooks easily swell totriple their original size. It is a nightmare for archivists,not to mention a frustration to the intellectual propertystaff.

Manually copying documentation into a paper note-book is counterproductive and takes up the valuable timeof the highly qualified workforce. Worse still, in the grow-ing area of in silico studies, or in studies where massiveamounts of digital raw data is generated, the mere idea ofputting everything down in a bound paper notebookseems absurd. In addition, bound lab notebooks, sequen-tial in nature, are ill suited for documenting events occur-ring automatically and simultaneously, such as parallelsynthesis. The result of all this is a steadily decreasingquality of documentation that needs to be addressedimmediately.

‘Electronic’ is not ‘paperless’Many interested parties had been predicting that the legaladoption of electronic records in terms of evidence valuewas imminent and opted to wait for the legal precedent tohappen. Our personal opinion, and the experience ofrecent years, tells us that this might not be the case.

In the early years of computers, electronic records wereinferior to paper, being less reliable, easier to tamper withand more prone to inadvertent damage or destruction.Although the computer industry claims now that it has allthe components required to build reliable electronic docu-ments and signatures, the fact remains that by their nature,electronic records remain much less tangible than paper

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Electronic lab notebooks – a crossroadsis passed

‘…the adoption ofelectronic media for laboratorynotebooks is not arevolutionary change,but an evolutionaryprocess…’

Mats Kihlén, Head of ResearchInformatics, Biovitrum AB and Martin Waligorski, Systems Architect,Guide Konsult AB

www.drugdiscoverytoday.com

and are likely to continue to prompt extra scrutiny incourt. From the legal perspective, these technologies arealso very much new and unproven. Only five years ago,the FDA was the first legislative body to acknowledge theuse of electronic records and signatures for regulatorydocuments, but the related 21 CFR Part 11 has not beenfree of significant conceptual oversights.

All this has been bad news for the advocates of the ELN,simply because the ELN has been thought of as synony-mous with ‘paperless’. We do not think this is the case –and not just because of legal reasons. Often overlookedin the ELN debate, there is one more area in whichpaper records excel over electronic records – archiving.Considering that patent evidence is maintained for some-where around 30 years, in terms of durability and reliabil-ity, paper records are still far superior to their electroniccounterparts.

It would seem that the initial assumptions of an entirelypaperless ELN system were not realistic. Paper has to be in-volved at some stages of the process. Based on the currentstate-of-the-art, such a system would mean electronic dataentry and storage, augmented with signing and archivingin paper. Although it might sound like a compromise, it isnot – it is just a logical consequence of recognizing thedifferent strengths of paper and electronic media and usingthem to their best advantage.

Designing a solutionWe have listed a set of key requirements for a successfulhybrid ELN system:(1) End-user acceptance; the ELN must offer ease of use

comparable with or better than its paper counterpart.(2) Fully featured; an electronic system must be constructed

in such a way that paper notebooks can be altogethereliminated.

(3) Availability; like a paper notebook, the ELN must allowfor instant note taking as observations are made. Accessto a personal ELN must be provided to each scientist atall the usual workplaces.

(4) Legal; the system must provide legal evidence forpatent protection of the same or higher quality thanthe currently used paper notebooks.

(5) Flexibility; data differ significantly between scientificdisciplines. An electronic system must be able to ac-commodate all kinds of scientific data.

(6) Access; all lab notebook records should be categorizedand fully searchable.

(7) Longevity; the system shall support archiving of alllab records for a period of at least 30 years – beyondthe projected lifetime of computers running the ELNsystem.

Formulation of these requirements leads us to the insight that a successful ELN solution must not onlycomprise a piece of software, but also the organization ofthe work environment and procedures, supported with thenecessary hardware and material.

From the legal perspective, a hybrid system still pro-duces a signed original document on paper, so the evi-dence value of the records in potential court dispute isretained. As for the burden of manual signing andcountersigning records, proper procedures can make itabout as easy (or awkward, depending on your prefer-ence) as your lab notebook of today. For example, imag-ine that once every few days you decide to print a fewpages containing the newest additions to your ELN. Youthen pick the printed pages from the nearby printer, signthem, and go over to a colleague to get them verified andcountersigned. Once ready, you put the signed sheets intoa special envelope addressed ‘ELN Archive’, and puteverything in the outgoing mail basket. Difficult? Hardly.And you still have the electronic record available at yourcomputer to read, search or produce secondary copies foryour own use.

We are convinced that such a hybrid system will providean effective ELN solution. It is fully feasible today, providingthat a few points are given further attention. For example,although for legal purposes the system relies on paper, it isstill different from handwritten bound notebooks. In addi-tion, the old lab notebooks contain bound, pre-numberedpages, whereas computer printouts come on loose sheetsof paper. The risk of tampering with individual pages there-fore needs to be addressed. It can be done with a num-bering system identifying each experiment and sheet toensure that no alterations or deletions of paper recordshave been made.

The temptation of making the ELN generate therecords automatically should be avoided. However attrac-tive it might sound, it should be remembered that theprimary goal of a laboratory notebook is to take notes onobservations. Humans, not machines, should write thesenotes. Notes can contain things and ideas that arespontaneous, out of the ordinary and that do not fit inpredefined templates. Therefore, before doing anythingelse, the ELN system must be an effective notepad, pro-moting note taking rather than merely collecting datafrom automatic sources.

Make ELN the good news in your organizationOn a final note, it should be remembered that electronic ornot, badly maintained records are always harder to defendin court than orderly records. If a computer system helpsto keep orderly records, it might help to demonstrate in

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court the care and accuracy with which lab notes werecreated. Our experience shows that ELN often lead to betterand more complete notes, and most definitely more read-able ones! The ELN system might also provide supportinglegal evidence in the form of timestamps, chronology ofevents, audit trail data and so on.

So our conclusion is – there is no need to wait. If ELNsare compatible with your knowledge management strategy,they are well worth using. The technology is there, legalissues are manageable, as is the work process associated withthe hybrid system. By following the guidelines describedhere, by taking the holistic approach and by taking into

account the computer software, policies, work processesand quality in your organization, you have a great chancefor success!

Mats KihlénBiovitrum AB

SE-112 76 Stockholm, Swedene-mail: mats.kihlen@biovitrum.com

Martin WaligorskiGuide Konsult AB

Strandbergsgatan 12SE-112 51 Stockholm, Sweden

e-mail: martin.waligorski@guide.se

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