CSV - Intermediate

Computer System Validation – Risk Management

Risk, risk-based approach, risk-based decisions, and on and on. Clearly, expectations are to consider risk. But what does that mean? What does taking a “risk-based approach” to validation mean? In essence, the degree to which a computerized system is validated, and the level of controls implemented is based on risk. Are the risks associated with the application sufficiently controlled to minimize the effects? In this course we will cover in a clear concise manner how risk applies to your CSV projects.

CEU Credits: 0.1

Course Code: ELM-162

Duration: 60 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Introduction

Overview

Learning Objectives

Who Should Take This Course?

Course Modules

Module 1: Background

Where is Software Used?

Validation is More than Testing

Scope of this Course

Why Validate – Part 1

Why Validate – Part 2

Hope Through Validation

Regulations, Standards and Guidance

Module 5: Risk

Risk Based Approach

Where Does Risk Lie?

Baseline Set of Definitions

Risk Management

Risk Management Tools

Scoring the Risk

The Various Steps

Step 0: The Players

Step 1: Initial Assessment

Step 1: Identify Impacting Functions

Step 1: Identify Impacting Functions – Continued

Step 2: Assess Risk

Step 2: Assess Risk – Continued

Step 3: Identify Controls

Step 3: Identify Controls – Continued

Step 4: Implement Controls

Step 4: Verify Controls

Step 5: Review Risk

Conclusion

Final Assessment

Certification

Author

Kevin Martin

Managing Partner at Azzur

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