Electronic laboratory notebook

An electronic laboratory notebook (also known as electronic lab notebook or ELN) is a software program or package designed to replace more traditional paper laboratory notebooks. Laboratory notebooks in general are used by scientists and technicians to document, store, retrieve, and share fully electronic laboratory records in ways that meet all legal, regulatory, technical and scientific requirements. A laboratory notebook is often maintained to be a legal document and may be used in a court of law as evidence. Similar to an inventor's notebook, the lab notebook is also often referred to in patent prosecution and intellectual property litigation.

Electronic lab notebooks are a fairly new technology and offer many benefits to the user as well as organizations. For example electronic lab notebooks are easier to search upon, support collaboration amongst many users, and can be made more secure than their paper counterparts.

History of the ELN

While some credit Dr. Keith Caserta with the concept of an electronic version of the laboratory notebook, it's likely that others had similar early ideas on how to integrate computing into the process of laboratory note taking. Significant discussion concerning the transition from a pen-and-paper laboratory notebook to an electronic format was already in full swing in the early 1990s. During the 206th National Meeting of the American Chemical Society in August, 1993, an entire day of the conference was dedicated to talking about "electronic notebooks" and ELNs. "A tetherless electronic equivalent of the paper notebook would be welcomed by the working scientist," noted Virginia Polytechnic Institute's Dr. Raymond E. Dessy for the conference. Dessy had in the mid-1980s begun postulating on the idea of an electronic notebook, and by 1994 he provided one of the first working examples of an ELN.

By 1997, a special interest group called the Collaborative Electronic Notebook Systems Association (CENSA) formed. Supported by 11 major pharmaceutical and chemical companies, the consortium worked with scientific software and hardware vendors to facilitate the creation of an ELN that met the technical and regulatory needs of its members. The consortium at that time envisioned a collaborative ELN that "teams of scientists worldwide can use to reliably capture, manage, securely share, and permanently archive and retrieve all common data and records generated by research and development and testing labs."

In 1998 one of the first web-based versions of an ELN was introduced in the form of the University of Oregon's Virtual Notebook Environment (ViNE), "a platform-independent, web-based interface designed to support a range of scientific activities across distributed, heterogeneous computing platforms." This innovation would go on to inspire vendors in the 2000s to develop web-based thin-client ELNs for laboratories everywhere. Yet it likely wasn't until the Electronic Signatures in Global and National Commerce Act (ESIGN) in June 2000 that the true legal implications of a fully electronic laboratory notebook would have on the industry. If an ELN were to be responsible for providing validation during the patent processes and be valid for other types of audits, a mechanism for authenticating the origin of the ideas would be necessary. The ESIGN act meant that electronic records could be authenticated and digital signatures made legally binding, lending further relevancy to ELNs.

Enthusiasm for ELNs began to pick up again in the early 2000s, with a strong case for further data integration into ELNs being made at the CENSA-sponsored International Quality & Productivity Center (IQPC) conference in London during September 2004. During that conference the push for stronger data integration was made, with the base premise that "ELNs would improve corporate strategy by allowing information to be used more intelligently with the help of decision-support software." By early 2007, industry-specific ELNs were pushing growth in the market: Scientific Computing World estimated 83 percent of related organizations declaring interest in ELNs, with 43 percent of those organizations seriously considering an evaluation or purchase. Scientists and academics — traditionally slow to adopt technological change — were gradually warming up to the benefits of an electronic laboratory notebook. And despite the beginnings of economic downturn, Atrium Research estimated in June 2009 that ELN's market potential was around $1.7 billion.

Regulations and legal aspects

The laboratory accreditation criteria found in the ISO 17025 standard needs to be considered for the protection and computer backup of electronic records. These criteria can be found specifically in clause 4.13.1.4 of the standard.

Electronic lab notebooks used for development or research in regulated industries, such as medical devices or pharmaceuticals, are expected to comply with U.S. Food and Drug Administration (FDA) regulations related to software validation.<ref="21CFR11">"The Code of Federal Regulations Title 21 Part 11". U.S. Food and Drug Administration. 1 April 2010. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=11&showFR=1. Retrieved 2011-05-04.  </ref> The purpose of the regulations is to ensure the integrity of the entries in terms of time, authorship, and content. Unlike ELNs for patent protection, the FDA is not concerned with patent interference proceedings, but rather with avoidance of falsification.

Typical provisions related to software validation are included in the medical device regulations at 21 CFR 820 (et seq.) and 21 CFR 11. Essentially, the requirements are that the software has been designed and implemented to be suitable for its intended purposes. Evidence to show that this is the case is often provided by a software requirements specification (SRS) that lays out the intended uses and needs that the ELN will meet. The SRS typically includes one or more testing protocols that, when followed, demonstrate that the ELN meets the requirements of the specification and that the requirements are satisfied under worst-case conditions. Security, audit trails, prevention of unauthorized changes without substantial collusion of otherwise independent personnel (i.e. those having no interest in the content of the ELN such as independent quality unit personnel) are all fundamental to the ELN. Finally, one or more reports demonstrating the results of the testing in accordance with the predefined protocols are required prior to release of the ELN software for use. If the reports show that the software failed to satisfy any of the SRS requirements, then corrective and preventive action (CAPA) must be undertaken and documented. Such CAPA may extend to minor software revisions, or changes in architecture or major revisions. CAPA activities need to be documented as well.

Modern features of an ELN

ELNs can be divided into two categories:

• "Specific ELNs" contain features designed to work with specific applications, scientific instrumentation or data types.

• "Cross-disciplinary ELNs" or "Generic ELNs" are designed to support access to all data and information that needs to be recorded in a lab notebook.

A good electronic laboratory notebook should offer both a secure environment to protect the integrity of both data and process, whilst also affording the flexibility to adopt new processes or changes to existing processes without recourse to further software development. The package architecture should be a modular design, so as to offer the benefit of minimizing validation costs of any subsequent changes that you may wish to make in the future as your needs change.

A good electronic laboratory notebook should be an "out of the box" solution that as standard has fully configurable forms to comply with the requirements of regulated analytical groups through to a sophisticated ELN for inclusion of structures, spectra, chromatograms, pictures, text, etc where a preconfigured form is less appropriate. All data within the system should be stored in a database (eg. MySQL, MS-SQL, Oracle) and therefore be fully searchable. The system should enable data to be collected, stored and retrieved through any combination of forms and/or ELN that best meets the requirements of the user.

The application should enable secure forms to be generated that accept laboratory data input via PCs and/or laptops / palmtops, and should be directly linked to electronic devices such as laboratory balances, pH meters, etc. Networked or wireless communications should be accommodated for by the package which will allow data to be interrogated, tabulated, checked, approved, stored and archived to comply with the latest regulatory guidance and legislation. A system should also include a scheduling option for routine procedures such as equipment qualification and study related timelines. It should include configurable qualification requirements to automatically verify that instruments have been cleaned and calibrated within a specified time period, that reagents have been QC'd and are not expired, and that workers are trained and authorized to use the equipment and perform the procedures.