Impact of the implementation of a well-designed electronic laboratory notebook on bioanalytical laboratory function

Author:

Zeng Jianing,Hillman Mark1,Arnold Mark2

Affiliation:

1. Research Informatics Department, Bristol-Myers Squibb Company, Princeton, NJ 08540, USA

2. Bioanalytical Sciences Department, Bristol-Myers Squibb Company, Rt. 206 & Province Line Road, Princeton, NJ 08540, USA

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.

Publisher

Future Science Ltd

Subject

Medical Laboratory Technology,Clinical Biochemistry,General Pharmacology, Toxicology and Pharmaceutics,General Medicine,Analytical Chemistry

Reference12 articles.

1. ZengJ, Hillman M, Arnold ME. Transitioning to the next generation bioanalytical process and data management through an integrated electronic notebook. Presented at:Applied Pharmaceutical Software Conference. Langhorne, PA, USA, 29 July 2009.

2. A Review of Electronic Laboratory Notebooks Available in the Market Today

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

4. ELN implementation challenges

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