Fundamentals Series

The Fundamentals of Computer System Validation

Whether you are configuring a new system or making a change in a validated system (e.g., upgrades, patches), CSV processes are based on applicable regulations and guidance, best practices for the industry, and the characteristics of the system being validated.

This course is designed to give you a high-level understanding of applicable regulations, the benefits of using a CSV process, the non-compliance risks, scope, and applicability to various systems utilized in the life sciences industry.

Computer System Validation generally comprises both computer hardware as well as computer software. Not everyone at a company plays a direct role in CSV processes, but support from many different areas is required for successful implementation.

For this reason, it’s crucial to understand what entails CSV processes, why it’s so important and how various roles impact regulatory compliance.

CEU Credits: 0.1
Course Code: ELM-230
Duration: 25 mins
Skill Level: Basic
Language: Chinese (Simplified), English, French (France), German, Italian, Japanese, Portuguese (Brazil), Spanish (Spain)
Final Exam: Yes
Certification: Yes
Version: V1.2
Effective Date: 24/02/2023

Curriculum for this course

Course Overview
1 min 45 secs
What You'll Learn
34 secs
CSV Definition
1 min 40 secs
CSV Global Regulations
1 min 40 secs
CSV Purpose and Benefits
1 min 12 secs
Non-Compliance Risks
1 min 20 secs
Systems Applicability
37 secs
Roles and Responsibilities
1 min 7 secs
System Risk Assessment
1 min 9 secs
System Risk Mitigation
39 secs
CSV Methodologies
1 min 8 secs
CSV Process Overview/System Development Life Cycle
1 min 30 secs
Data Migration and Data Transfer
1 min 21 secs
COTS, Cloud, Saas, PaaS, IaaS
2 min 31 secs
FDA CSA Draft Guidance (Sept 2022)
2 min 20 secs


Test Your Knowledge

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Ritesh Betala

Managed Services Program Validation Lead/IT Project Manager


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