ABSTRACT

Compliance practices for computer systems have been presented in line with current expectations of GxP regulatory authorities and industry practice. This chapter now concludes the first part of this book by reviewing some fundamental concepts and industry trends that will affect how we validate in the 21st century. Specific guidance for different types of computer system can be found in the case studies presented in the second part of this book. The authors of these case studies are themselves experienced practitioners and they have been encouraged to focus their papers on the key issues impacting their respective subject matter.