1. Introduction ...................................................................................................... 9 1.1 Scope and purpose of this document ..................................... 10 1.2 Ownership, status & relationship to other documents ........ 11 1.2.1 Ownership of the document ......................................................................... 11 The status of this document .......................................................................... 11 Relationship to other documents ................................................................ 11 2. An overview of the Project ............................................................................ 13 2.1 A description of the Project .................................................... 14 2.1.1 Standard Modules ............................................................................................. 14 Application Modules ........................................................................................ 17 Other module types ........................................................................................ 22 2.2 Objective and benefits ............................................................. 23 2.3 Regulations and standards ...................................................... 23 2.3.1 GxP requirements ............................................................................................ 24 Regulations, legislation and standards ......................................................... 24 2.4 Background to the Project ...................................................... 25