- 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
Client Engagement Manager,
Michael J. Hayes
About the Authors
Joe Rajarao, Ph.D is Client Engagement Manager at IDBS. In this capacity, Joe is focused on nurturing relationships with strategic customers to increase the value of their investment in the IDBS platform. Prior to this, as a Lead Consultant at IDBS, Joe implemented scientific data and workflow management systems in laboratories across pharmaceutical, biotech and contract research organizations. In addition, Joe’s responsibilities included oversight of IDBS’ Bioanalysis Solution, a suite of workflows that support small and large molecule bioanalysis in both regulated and non-regulated environments. Prior to joining IDBS, Joe was a Senior Scientist at Wyeth Research (acquired by Pfizer) where he led assay development and validation for drug development programs. Joe obtained his PhD in Pharmacology from The Penn State College of Medicine, and also earned an MBA from The Pennsylvania State University. Joe’s publication record spans functional genomics, bioinformatics, in vitro pharmacology and neuropsychiatric drug development.
Michael J. Hayes
Michael J. Hayes, Ph.D. is a member of the Drug Metabolism department at the Novartis Institutes for Biomedical Research (NJ, USA). He has extensive experience in providing bioanalytical support for all aspects of the drug development process, including drug discovery, pre-clinical GLP studies, clinical support and post registration drug level monitoring. He is currently global head of the electronic notebook and Watson laboratory information management system and project tracking systems for the Novartis DMPK department. Michael is heavily involved with all aspects of electronic data management and archiving operations, including the development of strategies for more effective use of electronic data systems to share data and fulfill both regulatory and intellectual property requirements. He received his B.S. in chemistry from the Lowell Institute of Technology (MA, USA). After receiving his Bachelor’s degree, he worked as a synthetic chemist at Northeastern University (MA, USA) and as an analytical chemist with Arthur D. Little, Inc. (MA, USA) working in the area of environmental analysis. He received his Ph.D. in chemistry from Northeastern University and has published over 33 scientific papers.
Electronic notebooks in the bioanalytical lab: a perspective on determining return on investment (ROI)
Advances in laboratory systems have expanded the sheer magnitude of data generated by a bioanalytical laboratory. Recording this data falls into two distinct categories, electronic and paper. Electronic records, such as instrument output files, can be stored and curated in a consistent manner. On the other hand, paper records, such as sample preparation notes and logbooks, tend to defy order and structure. In addition, the burden of curating paper records is significant. Electronic laboratory notebooks (ELNs), which effectively eliminate paper records, have evolved from simple paper replacement mechanisms (so-called, ‘paper on glass’) to drivers of process improvement. This transformation, however, comes at a price that must be justified. This price is in the form of both direct costs and opportunity costs. A return on investment (ROI) calculation is one of the ways such a decision can be objectively, and quantifiably, assessed.
I. Why go electronic?
a. Background – issues facing the bioanalytical lab and a role for electronic laboratory notebooks (ELNs)
Electronic tools have revolutionized the execution of bioanalytical (BA) processes in the laboratory. The turn of the last century ushered the advent of more precise scientific instrumentation as well as a plethora of specialized software solutions to streamline lab processes and manage the data deluge. These systems, sporting monikers such as laboratory information management systems (LIMS), electronic documentation management systems (EDMS) and chromatography data systems (CDS), have revolutionized how BA scientists generate and analyze the data gained from their precious samples. Further, CROs face the additional burden of implementing systems that manage commercial aspects of the operation, such as enterprise resource planning (ERP) and customer relationship management (CRM). As such, most BA labs now manage a constellation of software applications that each manage a portion of the overall operation.
It quickly becomes obvious that each of the above applications plays a role in a very specific niche. Whether dealing with data acquisition, sample management, method/protocol management or data analysis, these tools are highly specialized and have become critical to the BA enterprise. However, documenting the primary activity of the laboratory chemist is usually relegated to a paper record – prone to loss, damage and manual quality control. In spite of laboratory methods being deployed as standardized forms, with structured entry fields, the paper lab notebook remains the de facto standard format for record keeping. Given that the paper record has proven itself from the time of Da Vinci and Galileo, it is sometimes the last aspect of the lab operation that managers wish to disrupt.
However, changes in three main areas necessitate a re-evaluation of this paper-based paradigm: