Purpose

This paper reviews the principles of risk management in software development of GxP systems, elaborates on the well-known risk management approaches and identifies some of the important concepts of proactive management of risks throughout the software development lifecycle.

Audience

This Technical paper is applicable to audiences as identified below:

1. Project Managers
2. IT Validation Consultants
3. QA Consultants.

Prerequisites

The list below provides prerequisites for the users of the Technical Paper:

1. Familiarity with ANSI/AAMI/IEC 62304
2. Familiarity with GAMP 5
3. Familiarity with TIR36:2007
4. General Knowledge of risk management.

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