Why move from pencil and paper lab notebooks to an Electronic Lab Notebook (ELN)?
It's clearly time to make the change to the paperless lab. In tough economic times, research organizations all over the word are placing increasing emphasis on legal accountability, commercial patent protection, secure collaboration and intellectual property rights. Subsequently, many researchers are finding that taking notes with pencil and paper, and storing digital information in ad-hoc, unstandardized or non-compliant systems can be legally risky, expensive and inefficient. More and more organizations are seeing the benefits of storing and managing their research assets in a centralized server-client system that allows workgroup organization, controlled access, advanced searching and authenticated audit trails. Finally, administrators can instantly see WHO is performing research, WHEN and WHY they did it, and exactly WHAT was discovered and recorded.
ELN solutions (also known as Electronic Lab Notebooks. ) ELNs can help organizations of any size gather, track and manage research data. A good ELN is also highly customizable and extensible, capable of interfacing with other sources of data in ways that administrators can closely control.
The best ELNs are usually created by former research scientists and offer free trials to customers who aren't quite sure how laboratory notebook software can help them.
If you know of any research groups that are about to embark on an expensive new research project, a risky collaborative venture, or research in a strictly regulated or legally "high stake" sector, I would strongly urge you to tell them to investigate the use of ELN software as way to protect their R&D investment and avoid accountability issues that can be the consequence of inaccurate research record-keeping. If you or your organization needs help with this difficult decision, you might want to contact a good ELN consultanting firm like Lab-Ally.
A good ELN enables
scientific organizations to securely record their research and
capitalize on their knowledge assets.ELNs replaces both the
traditional pencil and paper lab notebook and the cumbersome, bulging
file cabinets still common in many laboratories. ELNs promote
efficiency, reduces costs and protects your R&D investment. It
also brings your laboratory into compliance with increasingly
stringent government and institutional regulations that specify how
research data must be recorded, archived and submitted during legal
proceedings.
With
With a good ELN you can:
• Gather
research data from any source, in any format, from scattered physical locations and securely store these assets in a central secure server.
• Digitally authenticate research data using customized signature workflows and maintain audit trails and that meet government guidelines such as 21CFR11.
• Control user access in subtle yet powerful ways that allow organizations to carefully decide who has access to data and what they are allowed to do with it.
• Use full text searches or our proprietary semantic metadata searches to locate and track information in ways our competitors cannot match.
• Easily duplicate, archive, distribute copy and organize any amount of data.
• Interface
with other databases and technologies to allow diverse forms of
access, interaction and collaboration.
• Avoid redundancy and repetition of work by coordinating research efforts across entire organizations.
• Scale from single users to multinational corporate enterprises with ease.
• Organize your scientists into logical collaborative workgroups without regard to their physical location.
• Organize, document and securely share your lab procedures, protocols, literature, thoughts and ideas.
• Coordinate
and supervise research teams, no matter where they are, or who they
report to.
A good ELN is sophisticated but not complicated
- it has the rich set of customizable features to fit the rules and
workflows of your organization and the individual work habits of your
users. It is easy to use and fast to deploy. The advanced functions are kept where
only those who need them have rapid access, and end users are quick
to adopt daily use. A good ELN should be very flexible, with
multiple modes for data entry and support for many manual and
automated data acquisition paths. A good ELN lets you work right “in the
notebook” to author and edit content in real time rather than
working offline, and then having to duplicate all your work to a
secure server later. IA good ELN is not just a data reporting tool – you
can also manage all your documents and keep a full record of past
versions of anything you work with. You can quickly find supporting
literature using our advanced semantic searches, monitor the progress
of collaborative documents written by many co-authors, annotate the
latest version of a paper written by a single graduate student in
your lab, or digitally sign a dissertation chapter submitted by a
student whose committee meeting you could not attend. A good ELN manages
and connects you to other people and projects in your organization
and notifies you whenever action is required. It’s like having your
own personal assistant!
.
Collaboration
– Six Risks to Intellectual Property
that
can be avoided by using
Electronic
Laboratory Notebooks
By
Jeff Spitzner, Ph.D.
Full text available here.
While partnerships play an increasingly critical role in the drug development lifecycle, a poorly structured partnership can expose your intellectual property (IP) to considerable risk. By understanding six common sources of risk, you can take steps to protect your investment.
Documentation
If collaborators have inconsistent documentation practices, you must assume that IP defense will be judged on the lower of the two standards.
Advanced Disclosure
Disclosure of data before patents are filed is always a concern, but this risk is exponentially greater in a collaborative environment.
Adverse Data
Failure to identify and address adverse data findings is another source of risk for research organizations. During legal proceedings for patents or efficacy, these “skeletons” can put your investment at risk.
Organizational Risks
When considering the risks of collaboration, it’s natural to focus on paper and electronic records. Unfortunately, even the company’s personnel policies can create risk for your investment. If a partner loses a scientist affiliated with your project, you can lose access to months – even years – of knowledge.
Patent Filing and Defense
Once the research is completed, your partner must assist in identifying and protecting your research.
Preservation
Even after a patent has been protected, your partner’s procedures could still undermine the profitability of your investment. Regulatory agencies require many records be retained long-term, in some cases beyond even the end of the patent.
Conclusion
Partnerships
can deliver tremendous benefits through innovative technologies,
lower costs, greater speed and agility, and a range of talent and
expertise not practical to maintain within a single organization.
However, the value generated in a partnership is realized not through
the contents at the bottom of a test tube, but rather through the
creation, capture, and exploitation of the resulting knowledge,
records, and intellectual property (IP). With great opportunity
comes great risk, increasing the necessity of protecting your
investment by enforcing adequate procedural and technical controls
both within your organization and within your partner’s. Be
certain you can trust – and verify – the results of
collaboration; your success is at stake.
ELNs have demonstrated their scientific and business value for chemists in R&D organizations. Now, biologists are seeking these same benefits in an ELN product that fits their needs. Chemistry-focused ELNs have proven not to serve the demands of biologists, nor have these chemistry products been easily retrofitted for other user communities. Similarly, generic ELNs that basically substitute digital text files old paper lab notebook have not been very useful for biologists. Such products may bring some of the advantages of computer record keeping, but they do not help the scientists manage the complex data and processes associated with their R&D activities.
The inability of chemistry or generic ELN products to serve multidiscipline life scientists can be attributed in large part to differences in how biologists work. The varied nature of the biological research habits and information products includes free-form protocols, a complex mix of structured and unstructured data, a diversity of methods and materials, and a lack of common software applications, databases, and research workflows among a collection of biologists, even within a single organization. For these reasons, chemistry-based and generic ELNs lack the versatility to support the scientific work of biologists, and as a result, vendors of these products are failing to serve the multidiscipline life sciences market. In certain cases, chemistry ELNs have been used to support some record-keeping functions for biologists; however, the products are clearly not easily retooled to support the scientific work of biologists. Finally, many ELN products look like science but on closer examination we see that they actually just capture Microsoft OLE objects or attachments without gathering meaningful scientific metadata or tracking, annotating, reporting, or signing of the real data.
Wikipedia entry for Electronic Lab Notebooks
The digital lab; trends in ELN software
