Electronic lab notebook

An electronic lab notebook (also known as electronic laboratory notebook, or ELN) is a software program designed to replace paper laboratory notebooks. Lab notebooks in general are used by scientists and technicians to document research, experiments and procedures performed in a laboratory. A lab 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.

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.

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 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 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) 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.).

External links

* [http://www.e-lab-book.com Non-commercial/Academic ELN information]
* [http://www.genengnews.com/articles/chitem.aspx?aid=1075 Tutorial: Electronic Laboratory Notebook Systems (Genetic Engineering News)]
* [http://www.scientific-computing.com/scwjunjul06elns.html ELNS Worthy of note (Scientific Computing World)]
* [http://www.scientific-computing.com/features/feature.php?feature_id=50 The State of the ELN Market (Scientific Computing World)]
* [http://www.isoiec17025.com ISO/IEC 17025 Resource Center]