title: Impact of the implementation of a well-designed electronic laboratory notebook on bioanalytical laboratory function.
abstract: This paper shares experiences of the Bristol-Myers Squibb Company during the design, validation and implementation of an electronic laboratory notebook (ELN) into the GLP/regulated bioanalytical analysis area, as well as addresses the impact on bioanalytical laboratory functions with the implementation of the electronic notebook. Some of the key points covered are: knowledge management - the project-based electronic notebook takes full advantage of the available technology that focuses on data organization and sharing so that scientific data generated by individual scientists became department knowledge; bioanalytical workflows in the ELN - the custom-built workflows that include data entry templates, validated calculation processes, integration with laboratory information management systems/laboratory instruments, and reporting capability improve the data quality and overall workflow efficiency; regulatory compliance - carefully designed notebook reviewing processes, cross referencing of distributed information, audit trail and software validation reduce compliance risks. By taking into consideration both data generation and project documentation needs, a well-designed ELN can deliver significant improvements in laboratory efficiency, work productivity, and regulatory compliance.
authors: Bioanalytical Sciences Department, Bristol-Myers Squibb Company, Rt. 206 & Province Line Road, Princeton, NJ 08540, USA. jianing.zeng@bms.com
authors: Jianing
authors: J
authors: Zeng
authors: Mark
authors: M
authors: Hillman
authors: Mark
authors: M
authors: Arnold
mesh_terms: D002623:Chemistry Techniques, Analytical / Q000379:methods* / Q000592:standards; D006801:Humans; D007753:Laboratories / Q000592:standards; D011786:Quality Control; D011996:Records; D012984:Software