Introduction

This introduction presents an overview of the key concepts discussed in the subsequent chapters of this book. The book contains a high-level description of the validation process applicable to computer systems to achieve and maintain proper performance, correct operation, system integrity and product quality by computer systems in a manufacturing environment. It considers expectations by regulatory authorities from the US, Australia, Brazil, Canada, China, United Kingdom, and Japan. The book covers common factors and e-compliance practices followed in computer systems validation (CSV). It discusses the key issues in the implementation and maintenance of the requirements. The book provides the concepts for the qualification of infrastructure. It recommends an approach to the correlation between the system life cycle (SLC) and e-records life cycle using the EU Annex 11 SLC. The book suggests an organization structure supporting CSV programs.