- Chapter 1: Laboratory informatics for the bioanalytical laboratory
- Chapter 2: Laboratory information management systems (LIMS) for bioanalysis
- Chapter 3: Development of an integrated informatics solution for advanced bioanalytical business analytics
- Chapter 4: Electronic notebooks in the bioanalytical lab: a perspective on determining return on investment (ROI)
- Chapter 5: Electronic notebooks: the paperless laboratory
- Chapter 6: Computerized system validation
- Chapter 7: Importance and application of electronic standards in bioanalysis
- Chapter 8: Automation tools
- Chapter 9: The future of big data in regulated bioanalysis: clouds, trends and transparency
- Appendix: Pertinent Regulations and Guidances in Electronic Data Use
Sarah K Peters
Linda L Sloup
Bioanalytical Method Development Technical Writer
About the Authors
Sarah K Peters
Sarah K Peters is a senior scientist at Celerion. In addition to developing methods for large-molecule analysis, she is a system administrator for the electronic laboratory notebook (ELN) in use at Celerion and was involved in the global implementation of the ELN system for bioanalysis within the company.
Linda L Sloup
Linda L Sloup is a bioanalytical method development technical writer at Celerion with experience in medical laboratory science and method development/validation for small-molecule bioanalysis. She is a system administrator for the electronic laboratory notebook (ELN) used by Celerion and has been involved in the company’s global implementation of ELN for bioanalysis and early clinical research.
Electronic notebooks: the paperless laboratory
For the past two decades, the paperless laboratory has been heralded as the “holy-grail” for documentation in bioanalytical laboratories. More recently, academic laboratories are also starting to realize and benefit from digital documentation systems. As compliance has become more and more important in the bioanalytical laboratory, the pressure to develop an electronic laboratory notebook (ELN) system has increased. Furthermore, as regulatory agencies have uncovered serious compliance and traceability issues with some bioanalytical laboratories, the bioanalytical community is now beginning to fully realize the advantage ELNs have in eliminating many compliance issues. Included in the discussion below are just some of the benefits of and several key considerations for implementing an ELN in the quest to achieve a paperless laboratory.
ELNs are not just a replacement for paper laboratory documentation; attempts to do so in the 1990s were market failures . Rather, ELNs offer the flexibility to modify or implement new processes in a secure environment while at the same time providing the rigidity necessary to ensure that processes stay within mandated design. An ELN can provide a centralized location for the documentation of experiments and can also provide the templates to ensure the experiments are run as methodology dictates. It can integrate the use of laboratory equipment to provide one electronic, centralized location for all laboratory and study information in one environment, as opposed to multiple documentation locations. It allows for data collaboration, accessibility, review and sharing within a single laboratory, or across bioanalytical sites in multiple countries or continents while still maintaining all the information in a secure, shared location. Essentially, ELNs are not just the means of recording laboratory information; they must also provide usability of the electronically recorded information .