CSV - Intermediate

Computer System Validation – Maintaining the Validated State

Changes can be sneaky little things. There are many ways a system can move out of a validated state. Changes directly to the software are the obvious ones that could impact the validated state and procedures need to be defined as to how the changes are controlled and the system re-validated following the change (and of course, before deployment). In this course we will guide you on how to maintain the validated states of your computer systems.

CEU Credits: 0.1

Course Code: ELM-166A

Duration: 45 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.1

Effective Date: 08/16/2021

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 9: Maintaining the Validated State

Meeting the Intended Use

How Can We Move Out of a Validated State?

Normal Use

Software Changes to Resolve Issues

Patches and Updates

Evolution

Infrastructure (Hardware)

Periodic Review

Dealing with Change

Change Documentation

Impact Assessment

Change Control

Re-Validation

Release Management

Conclusion

Final Assessment

Certification

Revision History

Minor Update: Course updated to modernize the course design.

V1.1

Author

Kevin Martin

Managing Partner at Azzur

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