ISBN: 978-1-910419-66-3 (Online)

Editor: Chad Briscoe (PRA Health Sciences) & Ling He (Daiichi-Sankyo)

 

Contents:

Foreward

This foreword provides an introduction to the use of computerized systems in bioanalysis and a breakdown of the content in this eBook.

 

Chapter 1: Laboratory informatics for the bioanalytical laboratory

This chapter covers the use of various informatics applications to automate the core business process of a bioanalytical laboratory.

 

Chapter 2: Laboratory information management systems (LIMS) for bioanalysis

This chapter discusses what a laboratory information management system (LIMS) is and the functions that it automates within a bioanalytical laboratory.

 

Chapter 3: Development of an integrated informatics solution for advanced bioanalytical business analytics

This chapter details how a centralized informatics platform will uniquely position the bioanalytical laboratory in the achievement of near real-time information, greater control, improved communication and reduced operational costs.

 

Chapter 4: Electronic notebooks in the bioanalytical lab: a perspective on determining return on investment (ROI)

In this chapter the return on investment (ROI) metric to evaluate the value of electronic laboratory notebooks is covered.

 

Chapter 5: Electronic notebooks: the paperless laboratory

In this chapter some of the benefits of and several key considerations for the implementation of an electronic laboratory notebook are discussed.

 

Chapter 6: Computerized system validation

In this chapter the four major elements of computerized system validation – the system life cycle, software classification, documented evidence and risk assessment – are presented and discussed.

 

Chapter 7: Importance and application of electronic standards in bioanalysis

This chapter provides a description of the problems associated with the language barrier, or lack of electronic standards or their effective application and the benefits of building standards into the applications and systems that support bioanalysis.

 

Chapter 8: Automation tools

In this chapter the implementation of SMART– simple and intuitive to use, Mindful of user errors, Assay class automation, Rugged, robust and reliable, and Tied in with the organization’s IT systems – automation software tools for the wet chemistry side of the bioanalytical lab is discussed.

 

Chapter 9: The future of big data in regulated bioanalysis: clouds, trends and transparency

In this chapter three major bioanalytical trends deriving from changes in computing in the clinical trial area will be discussed here.

 

Appendix: Pertinent Regulations and Guidances in Electronic Data Use

This appendix table serves as a summary introduction to some of the more significant documents, which can be used use this as a guide to begin you own investigation and development of appropriate Standard Operating Procedures.