Computer Software Assurance for Life Sciences

FDA inspections have repeatedly shown that traditional Computer System Validation (CSV) practices can misdirect effort, over-validating low-risk software while under-focusing critical manufacturing risks. In response, the FDA introduced Computer Software Assurance (CSA), a modern, risk-based approach designed to improve how life-science companies validate production and quality-system software.

In this course, you’ll explore how CSA reshapes validation through structured risk assessment, critical thinking, and proportionate assurance activities. You’ll learn how to align software validation with real process risk while maintaining compliance with 21 CFR Part 11, Part 820, EU Annex 11, and GAMP 5.

Developed by experts in U.S. and global life-science software compliance, this self-paced course equips learners with the knowledge and confidence to implement CSA effectively and to explain why this modern approach is the future of software validation.

Upon successful completion, you will receive a validated certificate accredited with CPD/CEU credits, suitable for audit and compliance documentation.

✅ Who should enroll?

• Validation, Quality Assurance, and Quality Control professionals
• Regulatory Affairs specialists involved in software compliance
• IT and software engineers supporting GxP-regulated systems
• Project managers implementing production or quality-system software
• Audit and compliance teams assessing software assurance programs

🎯 What you’ll learn?

• Define CSA and differentiate it from traditional CSV approaches
• Understand key FDA regulations and international standards (21 CFR Part 11, Part 820, EU Annex 11, GAMP 5)
• Apply the CSA risk-based framework to evaluate software risk and determine assurance activities
• Leverage critical thinking and intended-use assessment to optimize validation efforts
• Integrate CSA practices into quality systems, change control, and audit-ready documentation

Curriculum:

Lesson 1: Introduction to Computer Software Assurance (CSA)
Lesson 2: CSA Regulation and Standards
Lesson 3: Understanding the Risk-Based Framework in CSA
Lesson 4: Risk-Based Framework – Identifying the Intended Use of Software
Lesson 5: Determining Software Risk and Applying Critical Thinking
Lesson 6: Managing Software Changes Using CSA Logic
Lesson 7: Selecting the Right Assurance Activities
Lesson 8: Integrating, Measuring, and Improving CSA
Conclusion
Assessment