Electronic Laboratory Notebooks in Pharmaceutical R&D: On the Road to Maturity

Abstract

Laboratory activities in pharmaceutical R&D, including planning, experimental design, execution, data collection, processing, and reporting, rely on computer systems significantly. New computer systems are routinely implemented to increase the efficiency and quality of work in every aspect of R&D. One notable exception is the laboratory notebooks, which have been slow to “go electronic.” Only in the last few years, technology began to improve and more companies started to implement electronic laboratory notebooks (ELNs). Because the laboratory notebook is primary evidence for the ownership of intellectual property, concerns on whether electronic records can be used as evidence for invention is wide spread. Many early adopters of ELN technology took a hybrid approach: entering data electronically but printing and signing the printouts. However, there is very little basis for such concerns as regulatory agencies accept electronic records. What is important is that any records, electronic or paper, should be managed properly to ensure authenticity and trustworthiness. There are many benefits associated with ELNs, the most significant of which is the ability to search records electronically. The use of ELNs significantly increases productivity for scientists, peer reviewers, and supervisors in R&D. Time spent in searching for patent support data in discovery areas and on compliance and procedure-related tasks in regulated areas would be reduced, freeing time for other productive tasks. If integrated with other laboratory information systems, ELNs will also provide ability to directly drill down to hard data such as compound registration, biological assay, drug safety measurements, and pharmaceutical tests. Developing an information architecture that supports the complete spectrum of data will ensure proper interface between ELNs and other systems. The increased acceptance of ELN technology, combined with the maturing of R&D computing environment in the pharmaceutical industry, suggests that ELNs will have a wider acceptance in the near future. (JALA 2007;12:157–65)