Why you need an ELN

Two hundred years ago, when Sir Isaac Newton and his colleagues implemented a major paradigm shift from alchemy to science ? rational thought, hypothesis, test, repeat - it was fine to record results on paper. Observation was everything, and the only types of scientific data they had could be represented with numbers, letters, and simple sketches. These scientists worked in isolation for years, until finally presenting their results to the Royal Academy.

That model doesn't work as well today. Science is more collaborative, more dispersed, and more immediate. Collaborators are down the hall as well as across oceans, and we need to collaborate instantly, because we aren't the only ones fighting for that grant/patent/publication. Everything has to happen now ? it needs to be validated and time-date stamped, and it must adhere to standards and regulations.

Add to that the fact that we are generating more data, and more elaborate types of data; paper just doesn't cut it anymore.

So what are the benefits of a well-designed, well-implemented electronic laboratory notebook (ELN)? 1.Better, faster collaboration

An ELN gives collaborators an instant view of all of the information they are permitted to access. This includes not only files and folders, but also notebooks of your peers and colleagues; you can see their work as they are doing it. But a good ELN is much more than that – it allows users to annotate entries on other individuals' notebooks, the digital equivalent of adding a sticky note. By leaving comments and feedback, or even files and protocols, on an electronic lab notebook, instantaneous collaboration is achieved. This eliminates the need to wait for others to finish using their notebooks or for a colleague to finish reviewing it ? multiple users can simultaneously see the same notebook.

This collaboration works whether you are in the same building or on opposite sides of the planet ? a good ELN allows access to the information anytime, anywhere, and it performs crucial validation and signature steps.

2.IP security and automatic compliance (time/date/user stamps, audit trails)

Securing your Intellectual Property (IP) is crucial. Even an academic lab faces competition from other researchers. In the race to patent or publish, nothing is more important than time. That means getting there first, and being able to prove it. The 21CFR11 requirements mandate time, date, and user stamps (as well as audit trails) for all research done in an ELN. Data validation requires both researcher and manager to sign off on the data. How many companies have lost a patent battle because of logistical pitfalls that mean signing can happen only when all the individuals involved are physically in the same room? Monthly signing parties are the standard at some organizations ? which means that the life-blood IP is not secure until well after it was created.

With an ELN, all data entered into the system are automatically time-, date-, and user-stamped ? saving the researcher precious seconds, which over the course of days, months, and years significantly add up. More important, audit trails track all the changes to the record (including access tracking, which is important in verifying protocol compliance or finding out who read a specific set of data, and when). An ELN does all of this automatically.

Why you need an ELN. Copyright © 2009 Rescentris, Inc. All rights reserved. By Wolfgang Rumpf, Ph.D.www.rescentris.com

A last, important consideration is that an ELN allows the digital signature workflow to occur asynchronously. In other words, a user can sign off on her work and move on to the next experiment while the ELN system functions as a "witness." The peers and managers, in turn, can review the work electronically (from anywhere) and cosign when they are ready. There is no waiting until the end of the month; the signing can be completed whenever, wherever ? most likely sooner than in the paper notebook world.

3.No more reinventing the wheel

There is more to securing intellectual property than simply making sure the basics of time/date/user stamp and resource audit trails have been properly captured. While this is sufficient to ensure legal compliance, the real advantage of securing IP is that it will be readily available to anyone in your organization.

In the paper world, notebooks are single-instance ? you can't easily create backup copies, you can't search a notebook by keyword, and your archived notebooks are essentially lost. Trying to find information in a paper notebook is often so cumbersome and difficult that it's faster to redo the experiment. Have you ever had to re-run a gel just to get a pretty picture because the original had notes written on it? How many hours - days - weeks of rework is done simply because we don't have easy and quick access to the original data?

The problem is really worse, because a researcher may repeat an experiment if he doesn't know that the organization already has the data. Pharmaceutical companies report that a large proportion of their experiments (as high as 66%) are inadvertent duplicates. They aren't repeating the science to validate it, but because they simply don't have good access to their own intellectual property.

A well-designed ELN with good search capabilities can prevent both of these problems. It will still be up to the user to actually do the search in advance of a new study (to avoid duplication), but the time savings are potentially huge. Imagine spending a few seconds doing a query every time a new project is started ? a small investment of time ? only to discover that someone has already optimized a protocol for those specific conditions? Even if that only happens once a year it will still be time well-spent and a huge cost savings for the organization.

4.Rapid approval and validation

Building on the above, it should seem obvious how the ability to sign off on an experiment rapidly and asynchronously could be applied to protocols, SOPs, and IRBs. An ELN can manage and track the design and approval of such documents as well as automate compliance, and the audit trail easily enables managers to see who has (or has not) read and signed off on any of these documents.

5.Reduced cost of recordkeeping and archiving

Many researchers may not realize that their paper notebooks can cost a significant amount of money ? much more than the simple composition book that it appears to be. Even a simple notebook costs something ? the more sophisticated paper notebooks used in the pharmaceutical and biotech industries involve tracking and management, and can cost significantly more. Now add in the cost of the archivist and librarians involved in this management, as well as the cost of archiving the paper, which may involve anything from duplication and preservation locally to off-site secure archiving for several years, if not decades. These costs rapidly become non-trivial, and by contrast an ELN can end up saving the

Why you need an ELN. Copyright © 2009 Rescentris, Inc. All rights reserved. By Wolfgang Rumpf, Ph.D.www.rescentris.com

organization money simply by reducing the archival costs (and by offering better search and retrieval, as outlined above).

Paper notebooks may cost more just for daily progress report meetings where each scientist creates duplicate copies of vital experiments and hands them out to every attendee, only to have these duplicates discarded at meeting's end. How much easier it is to connect a laptop to an overhead projector, display the results, and send direct in-system links via the ELN to the data so that each scientist can peruse the data directly ? with no additional cost, or waste of time.

6.Data/Notebook portability

There's a lot of transience in science ? particularly in academia. A question that frequently arises from academics is "who gets to keep the notebooks?"

After spending several months to several years on a project, it's nice to have something to show for it. It's common for graduate students and post-docs to "liberate" their notebooks when they leave the lab. Who can blame them, other than the PI, who also worked tirelessly on the project? Other than the grant- managing institution, which technically owns the data?

Notebooks can be photocopied, but the labor and resources involved often prevents this from happening. And what about data that are not amenable to duplication? An example is legacy data in the form of large auto-rads (exposed x-ray films) of polyacrylamide sequencing gels. These auto-rads were on the order of 20" x 50" in size ? not something that can be tucked into a notebook, and definitely not something easily duplicated. Today data comes off high-speed sequencers and micro-array machines and in-situ imagers that can all be pre-loaded with days' worth of runs, resulting in a profusion of data.You just can't take it all with you.

Enter the well-designed ELN. It deals with all data, all formats, and all sizes. No more copying and pasting (in the literal sense, using scissors and tape and glue). ELNs offer nightly incremental backups of everything ? lab data, journal articles, and notebooks. And, if the ELN is truly well designed, it promotes data portability. You should expect to get PDF printouts of the entire notebook (or portions) ? beautifully rendered, containing everything the scientist put into the experiment, and best of all, it is legible. Your ELN should export portable archives of notebooks, ready to import into the next ELN system that researcher works with. Finally, a good ELN gives you exported, portable archives of all the actual data files - text files, spreadsheets, instrument data, everything!

The above is hardly an exclusive list, but we hope you've found some compelling arguments for why an ELN is not just useful, but essential, to any organization that wants to stay competitive in the modern world of science. The question shouldn't be "Do we need an ELN?" rather the questions should be "Which ELN is right for us?"

About us: Rescentris, Inc. is the provider of CERF - enterprise software to help organizations protect their R&D investments and intellectual knowledge assets. CERF combines electronic lab notebook (ELN) and scientific content management to collect, secure, share, and leverage data and lab records in collaborative projects.

Why you need an ELN. Copyright © 2009 Rescentris, Inc. All rights reserved.