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An electronic lab notebook or electronic laboratory notebook (ELN) is a
computer program A computer program is a sequence or set of instructions in a programming language for a computer to Execution (computing), execute. It is one component of software, which also includes software documentation, documentation and other intangibl ...
designed to replace paper laboratory notebooks. Lab notebooks in general are used by
scientist A scientist is a person who Scientific method, researches to advance knowledge in an Branches of science, area of the natural sciences. In classical antiquity, there was no real ancient analog of a modern scientist. Instead, philosophers engag ...
s,
engineer Engineers, as practitioners of engineering, are professionals who Invention, invent, design, build, maintain and test machines, complex systems, structures, gadgets and materials. They aim to fulfill functional objectives and requirements while ...
s, and
technician A technician is a worker in a field of technology who is proficient in the relevant skill and technique, with a relatively practical understanding of the theoretical principles. Specialisation The term technician covers many different special ...
s to document
research Research is creative and systematic work undertaken to increase the stock of knowledge. It involves the collection, organization, and analysis of evidence to increase understanding of a topic, characterized by a particular attentiveness to ...
,
experiment An experiment is a procedure carried out to support or refute a hypothesis, or determine the efficacy or likelihood of something previously untried. Experiments provide insight into cause-and-effect by demonstrating what outcome occurs whe ...
s, and procedures performed in a laboratory. A lab notebook is often maintained to be a
legal document Legal instrument is a legal term of art that is used for any formally executed written document that can be formally attributed to its author, records and formally expresses a legally enforceable act, process, or contractual duty, obligation, o ...
and may be used in a
court of law A court is an institution, often a government entity, with the authority to adjudicate legal disputes between Party (law), parties and Administration of justice, administer justice in Civil law (common law), civil, Criminal law, criminal, an ...
as
evidence Evidence for a proposition is what supports the proposition. It is usually understood as an indication that the proposition is truth, true. The exact definition and role of evidence vary across different fields. In epistemology, evidence is what J ...
. Similar to an
inventor's notebook An inventor's notebook is used by inventors, scientists and engineers to record their ideas, invention process, experimental tests and results and observations. It is not a legal document but is valuable, if properly organized and maintained, since ...
, the lab notebook is also often referred to in
patent A patent is a type of intellectual property that gives its owner the legal right to exclude others from making, using, or selling an invention for a limited period of time in exchange for publishing an sufficiency of disclosure, enabling discl ...
prosecution and
intellectual property Intellectual property (IP) is a category of property that includes intangible creations of the human intellect. There are many types of intellectual property, and some countries recognize more than others. The best-known types are patents, co ...
litigation A lawsuit is a proceeding by one or more parties (the plaintiff or claimant) against one or more parties (the defendant) in a civil court of law. The archaic term "suit in law" is found in only a small number of laws still in effect today. ...
. Electronic lab notebooks offer many benefits to the user as well as organizations; they are easier to
search Searching may refer to: Music * "Searchin', Searchin", a 1957 song originally performed by The Coasters * Searching (China Black song), "Searching" (China Black song), a 1991 song by China Black * Searchin' (CeCe Peniston song), "Searchin" (C ...
upon, simplify data copying and
backup In information technology, a backup, or data backup is a copy of computer data taken and stored elsewhere so that it may be used to restore the original after a data loss event. The verb form, referring to the process of doing so, is "wikt:back ...
s, and support
collaboration Collaboration (from Latin ''com-'' "with" + ''laborare'' "to labor", "to work") is the process of two or more people, entities or organizations working together to complete a task or achieve a goal. Collaboration is similar to cooperation. The ...
amongst many users. ELNs can have fine-grained access controls, and can be more secure than their paper counterparts. They also allow the direct incorporation of data from instruments, replacing the practice of printing out data to be stapled into a paper notebook.


Types

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. * Lab Platforms that combine an ELN, LIMS, and scientific data management together, all-in-one configurable software environment. Solutions range from specialized programs designed from the ground up for use as an ELN, to modifications or direct use of more general programs. Examples of using more general software as an ELN include using OpenWetWare, a
MediaWiki MediaWiki is free and open-source wiki software originally developed by Magnus Manske for use on Wikipedia on January 25, 2002, and further improved by Lee Daniel Crocker,mailarchive:wikipedia-l/2001-August/000382.html, Magnus Manske's announc ...
install (running the same software that Wikipedia uses),
WordPress WordPress (WP, or WordPress.org) is a web content management system. It was originally created as a tool to publish blogs but has evolved to support publishing other web content, including more traditional websites, electronic mailing list, ma ...
, or the use of general note taking software such as OneNote as an ELN. ELN's come in many different forms. They can be standalone programs, use a client-server model, or be entirely web-based. Some use a lab-notebook approach, others resemble a blog. ELNs are embracing artificial intelligence and LLM technology to provide scientific AI chat assistants. A good many variations on the "ELN" acronym have appeared. Differences between systems with different names are often subtle, with considerable functional overlap between them. Examples include "ERN" (Electronic Research Notebook), "ERMS" (Electronic Resource (or Research or Records) Management System (or Software) and SDMS (Scientific Data (or Document) Management System (or Software). Ultimately, these types of systems all strive to do the same thing: Capture, record, centralize and protect scientific data in a way that is highly searchable, historically accurate, and legally stringent, and which also promotes secure collaboration, greater efficiency, reduced mistakes and lowered total research costs.


Objectives

A good electronic laboratory notebook should offer 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 may be stored in a database (e.g. MySQL, MS-SQL, Oracle) and be fully searchable. The system should enable data to be collected, stored and retrieved through any combination of forms 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 quality-checked and have not expired, and that workers are trained and authorized to use the equipment and perform the procedures.


Regulatory and legal aspects

The laboratory accreditation criteria found in the
ISO 17025 ISO/ IEC 17025 General requirements for the competence of testing and calibration laboratories is the main standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accr ...
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 FDA regulations related to software validation. 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, FDA is not concerned with patent interference proceedings, but is concerned with avoidance of falsification. Typical provisions related to software validation are included in the medical device regulations at 21 CFR 820 (et seq.) and
Title 21 CFR Part 11 Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures (ERES). Part 11, as it is commonly ca ...
.United States. Food and Drug Administration. Department of Health and Human Resources. Code of Federal Regulations - Title 21 Part 11 Electronic Records; Electronic Signatures. FDA.gov. Authority: 21 U.S.C. 321-393; 42 U.S.C. 262., 20 Mar. 1997. Web. 16 Nov. 2011. . 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) setting forth the intended uses and the needs that the ELN will meet; 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) and similar tests are fundamental. 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. Aside from the requirements to follow such steps for regulated industry, such an approach is generally a good practice in terms of development and release of any software to assure its quality and fitness for use. There are standards related to software development and testing that can be applied (see ref.).


See also

* List of ELN software packages *
Data management Data management comprises all disciplines related to handling data as a valuable resource, it is the practice of managing an organization's data so it can be analyzed for decision making. Concept The concept of data management emerged alongsi ...
*
Laboratory informatics Laboratory informatics is the specialized application of information technology aimed at optimizing and extending laboratory operations. It encompasses data acquisition (e.g. through sensors and hardware or voice), instrument interfacing, laborator ...
* Jupyter


References


Further reading

* * * {{DEFAULTSORT:Electronic Lab Notebook Research Scientific documents Notebooks Electronic documents Data management Content management systems Data management software