The status of electronic laboratory notebooks for chemistry and biology

Abstract

Documenting an experiment in a way that ensures that the record can act as evidence to support a patent claim or to demonstrate compliance with the US Food and Drug Administration's (FDA's) predicate rules, puts demands on an electronic laboratory notebook (ELN) that are not trivial. The 1996 General Agreement on Tariffs and Trade (GATT) allowed notebook records that were generated outside of the US to be used to claim precedence in US patent claims. This agreement spurred interest in the development of ELNs in Europe. The pharmaceutical research process became dependent on computer systems during the latter part of the 1990s, and this also led to a wider interest in ELNs. More recently, the FDA began to encourage submissions in an all-electronic form, leading to great interest in the use of ELNs in development and manufacturing. As a result of these influences, the pharmaceutical industry is now actively pursuing ELN evaluations and implementations. This article describes some of the early efforts and the recent drivers for ELN adoption. The state of the ELN market in 2005 is also described.