Computer Software Assurance (CSA): Building Risk-Based Validation for AI, SaaS & Digital Tools Moving from Documentation Burden to Evidence of Assurance

Life sciences organizations increasingly depend on digital technologies to manage manufacturing, quality, laboratory, and clinical operations. Cloud platforms, SaaS applications, automation tools, and AI-enabled analytics systems now play critical roles in ensuring product quality and patient safety.

However, many companies still apply traditional Computer System Validation (CSV) methods that were designed decades ago for static, on-premise software. These legacy approaches rely heavily on scripted testing, extensive screenshots, and large volumes of documentation intended primarily to prove compliance rather than demonstrate real assurance. The result is slow implementation cycles, excessive paperwork, and delayed innovation without meaningful risk reduction.

Computer Software Assurance (CSA) represents the FDA’s modernized approach to validation. Rather than focusing on documentation volume, CSA emphasizes critical thinking, risk-based testing, and objective evidence that systems function as intended. The goal is simple: apply the most effort where risk is highest and avoid unnecessary activities where risk is low. This shift enables organizations to deploy and update digital systems faster while still protecting patient safety, product quality, and data integrity.

This webinar explains how CSA replaces checklist-style validation with smarter, more targeted practices. Participants will learn how to evaluate system functions based on their potential impact and determine appropriate levels of testing and documentation. Instead of writing lengthy scripts for every feature, teams focus on critical workflows and use a mix of scripted, exploratory, and automated testing to generate meaningful evidence. Digital logs, automated outputs, and vendor documentation become acceptable proof of assurance, reducing reliance on manual screenshots and redundant paperwork.

The session also addresses today’s technology landscape. SaaS and cloud platforms follow shared responsibility models where vendors maintain infrastructure and core functionality, while users validate configuration and intended use. CSA encourages leveraging vendor testing and certifications as part of the overall assurance strategy. Similarly, AI and machine learning systems require lifecycle monitoring, model validation, and drift detection rather than one-time testing. These modern approaches better reflect how technology actually operates.

Participants will explore how to integrate CSA into existing quality systems, change control, and CAPA processes.

Emphasis is placed on right-sized documentation, electronic records, traceability, and metrics that demonstrate ongoing control. When implemented effectively, CSA reduces validation cycle times, improves collaboration between QA and IT, and supports faster adoption of innovative tools without compromising compliance.

By the end of the webinar, attendees will understand how to transition from traditional CSV to CSA and build a sustainable, risk-based validation program that delivers both efficiency and regulatory confidence.

Why should you Attend:
If your validation process feels slow, paperwork-heavy, and disconnected from real risk, this webinar will show you how to modernize it without sacrificing compliance. You’ll learn how to apply CSA principles to focus testing where it matters most, leverage vendor and automated evidence, streamline documentation, and validate today's SaaS and AI systems more efficiently. The result is faster system deployment, fewer validation bottlenecks, and stronger inspection readiness - helping your organization innovate confidently while meeting regulatory expectations

Areas Covered in the Session:

• Welcome & Objectives (5 min)
• Why traditional CSV is no longer sustainable
• FDA’s shift toward Computer Software Assurance (CSA)
• Impact of cloud, SaaS, and AI technologies
• Session goals and expected outcomes
• Learning objectives
• From CSV to CSA – Why Change Was Needed (8 min)
• Overview of Computer System Validation (CSV)
• Paper-heavy, script-driven validation
• Over-documentation without added assurance
• Slow system deployment and change cycles
• Barriers to innovation
• Regulatory drivers for modernization
• CSA Core Philosophy & Regulatory Foundations (8 min)
• “Assure what matters; document what’s necessary”
• Risk-based thinking
• Evidence over paperwork
• 21 CFR Parts 210, 211, 820, 11 alignment
• Integration with ICH Q9 risk management
• Alignment with ISO 13485/9001 frameworks
• Risk-Based Approach in Practice (10 min)
• Identifying critical system functions
• Patient safety, product quality, data integrity focus
• Risk categorization (high/medium/low)
• Proportional testing depth
• Recording rationale
• Practical risk scoring methods
• Mapping risk to test effort
• Testing That Matters (10 min)
• Scripted testing for high-risk functions
• Unscripted/exploratory testing
• Automated regression testing
• Digital evidence capture
• Avoiding unnecessary screenshots
• Using logs and system outputs
• Combining methods effectively
• Leveraging Vendors, SaaS, and Cloud Providers (7 min)
• Shared responsibility model
• Accepting vendor evidence
• Supplier qualification practices
• Configuration vs infrastructure validation
• Change notification management
• Documentation expectations
• AI/ML and Modern Digital Tools (6 min)
• Adaptive systems and lifecycle validation
• Model training and monitoring
• Drift detection
• Data provenance
• Human oversight controls
• Continuous verification concepts
• Documentation Under CSA (4 min)
• Right-sized documentation
• Traceability requirements
• Electronic validation tools
• Part 11 compliant records
• Clear, concise evidence packages
• Metrics, Audit Readiness & Continuous Assurance (5 min)
• Validation cycle time
• Defect detection effectiveness
• Automation coverage
• Living evidence trails
• Audit readiness practices
• Management review integration
• Key Takeaways & Wrap-Up (2 min)
• Focus on assurance, not paperwork
• Risk drives effort
• Automation enables efficiency
• Vendor evidence is valuable
• CSA supports faster innovation
• Compliance and agility can coexist

• Quality Assurance (QA)
• Quality Control (QC)
• Regulatory Affairs
• Compliance and Governance
• Internal Audit
• Manufacturing Operations
• Production Management
• Validation and Engineering
• Training and Learning & Development
• Document Control and Technical Writing
• CAPA and Investigation Teams
• Risk Management
• Supplier Quality Management
• Laboratory Operations
• Site and Plant Leadership
• Continuous Improvement / Operational Excellence
• Data Integrity and CSV/CSA Teams
• Clinical Operations (GCP environments)
• Contract Manufacturing Oversight
• Executive Quality and Compliance Leadership