- 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
Executive Director, Bioanalysis
PRA Health Sciences
11070 Strang Line Road
Lenexa, KS 66221
About the author
Chad received his Bachelor of Science degree in Chemistry from Alma College in Michigan and a Master’s degree in Analytical Chemistry from the University of Michigan with a focus in the use of LC-MS/MS in protein and peptide analysis. Chad’s Doctorate of Philosophy at the University of Nebraska was focused on studies of protein binding via affinity LC-MS/MS and computer simulations. Chad is currently the Executive Director of Bioanalytical Science at PRA Health Science. He was previously the Director of Bioanalysis at the Lincoln site of MDS Pharma services. He has become well known in the bioanalytical community on such diverse issues as the use of advanced LC-MS/MS technology applied to high-throughput analysis, system suitability in high-throughput LC-MS/MS and bioanalytical software validation. He has recently been an invited speaker on these topics at the Land O’Lakes Bioanalytical Conference, the Applied Biosystems American Society of Mass Spectrometry (ASMS) User’s Meeting, The Clinical and Pharmaceutical Solutions Through Analysis (CPSA) Meeting and the Boston Society’s Applied Pharmaceutical Analysis (APA) and Applied Pharmaceutical Software (APS) Meetings. Chad was also the Team Leader of the Global Bioanalysis Consortium’s Analytical Instrument Qualification Team and the editor for the Management and Leadership column in Bioanalysis. Chad was previously with Dow Corning where he specialized in LC-MS/MS techniques and high-resolution MS and GC solutions. He is also on the planning committees and has been chairperson for the Land O’Lakes Bioanalytical Meeting, Clinical and Pharmaceutical Solutions through Analysis Meeting and the Boston Society’s APS meeting.
Computers have enabled many of the recent advances in society. This is as true in bioanalysis and the pharmaceutical industry in general as in any other discipline. Bioanalysis does not just rely on computers and software but also a tremendous amount of computerized systems utilizing a complex interplay of hardware, firmware and software control. I would challenge you to find an article published about bioanalysis since its inception just a few years ago that did not have a computerized system of some sort as one of the enabling technologies at its core. I still frequently hear stories of someone cutting and weighing chromatographic peaks back in the “old days”; thankfully, electronic data acquisition systems are now a standard. Even the integrators that many of us used early in our careers had a computer chip at their core.
This text is focused on various aspects of computerized systems. It covers everything from application strategy to software validation and proper use of all types of computerized systems we see in our laboratories. While the emphasis of the chapters is on bioanalysis, it has broad applicability to any laboratory environment. There have been several important milestone moments in analytical and bioanalytical chemistry that relate directly to computerized systems but I don’t know that a single text has ever focused specifically on the accomplishments of these contributors to our field. These milestones have included electronic instruments, integrators, data acquisition systems, robotics, laboratory information management systems (LIMS) and electronica laboratory notebooks (ELNs), to name some of the more prominent.
With recent consolidations and cost-savings initiatives in the industry, we find that more than ever we are asked to do less with more. In bioanalysis, the push to increase output generally means to improve sample throughput. The answer to this challenge in many cases is with computerized systems such as new instruments, robotics or efficient laboratory execution system software. This text called on experts in computerized systems from a wide range of different areas, such as paperless laboratories, compliance issues and laboratory robotics, to help us ease the burden of implementing computerized systems as solutions to these problems. We are fortunate that they have found the time, probably in evenings and weekends, to share their experiences with us.
With that, I won’t take any more of your valuable time. I invite you to take a few moments from your day to read through this unique text focused on computerized systems. I am confident you will find information in this edition that will help you increase the performance of your laboratory operation through computerized systems. Enjoy your reading, appropriately delivered, electronically!