Doc: ps2001-5-1101-001 Rev: R02. 00



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PS2001-5-1101-001-URS
1486357009-URS, URS
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


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