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.

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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

1 min 01 secs

Learning Objectives

1 min 31 secs

Who Should Take This Course?

1 min 21 secs

Course Modules

1 min 10 secs

Module 1: Background

Where is Software Used?

1 min 05 sec

Validation is More than Testing

1 min 10 secs

Scope of this Course

1 min 10 secs

Why Validate – Part 1

1 min 10 secs

Why Validate – Part 2

1 min 07 secs

Hope Through Validation

1 min 24 secs

Regulations, Standards and Guidance

1 min 30 secs

Module 5: Risk

Risk Based Approach

1 min 12 secs

Where Does Risk Lie?

1 mins 29 secs

Baseline Set of Definitions

1 min 20 secs

Risk Management

1 min 25 secs

Risk Management Tools

1 mins 11 secs

Scoring the Risk

1 min 09 secs

The Various Steps

1 mins 23 secs

Step 0: The Players

1 min 11 secs

Step 1: Initial Assessment

1 min 14 secs

Step 1: Identify Impacting Functions

1 min 07 secs

Step 1: Identify Impacting Functions – Continued

1 min 22 secs

Step 2: Assess Risk

1 min 40 secs

Step 2: Assess Risk – Continued

1 min 09 secs

Step 3: Identify Controls

1 min 18 secs

Step 3: Identify Controls – Continued

1 min 18 secs

Step 4: Implement Controls

1 min 05 secs

Step 4: Verify Controls

1 min 39 secs

Step 5: Review Risk

1 min 19 secs

Conclusion

Final Assessment

Certification

Author

Kevin Martin

Managing Partner at Azzur

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