ABSTRACT

There is no substitute for extensive testing when it comes to IT systems. Recognition that problems are easier and cheaper to fix before the system is in use (rather than after), has turned testing into a cost-effective tool. However, when developing computer systems for pharmaceuticals manufacturing, testing to meet regulatory requirements adds an

chapter 1|2 pages

Purpose

chapter 2|2 pages

Scope

chapter 3|2 pages

Why Do We Test?

chapter 4|6 pages

What to Test

chapter 5|14 pages

The Test Strategy

chapter 8|14 pages

Good Testing Practices

chapter 16|4 pages

Appendix F – Risk-Based Testing

chapter 17|6 pages

Appendix G – Traceability Matrices

chapter 18|8 pages

Appendix H – Test Script Templates

chapter 19|6 pages

Appendix I – Checklists