Computer Software Assurance (CSA)

This course is designed to give you a high-level understanding of Food & Drug Administration (FDA) Computer Software Assurance (CSA) (Sept 2022) that has recently been issued as a risk-based approach to establish confidence in the automation used for production or quality systems.

We will learn the background on fruition of CSA, the applicability and usage of evolving technologies and processes, the various methods and testing activities that may be applied to provide objective evidence to fulfill regulatory requirements, such as 21 CFR Part 820, and changes from existing approaches and organizational challenges in implementation.

CEU Credits: 0.1

Course Code: ELM-195

Duration: 15 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Effective Date: 11/08/2023

Curriculum for this course

Course Introduction

What You Will Learn

CSA Background

History

Industry Standards Overview

Rational: Risk-Based CSA

CSA Framework

Intended Use Identification

Where is Validation Not Required?

Risk-Based Approach Determination

Assurance Activities Determination

Establishing/ Retaining Evidence Records

Examples

Implementation Approach

Conclusion

Summary

Test Your Knowledge

Results

Revision History

Author

Ritesh Betala

Managed Services Program Validation Lead/IT Project Manager

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