Modular Course for Practitioners

Why This Training Matters

Cloud-native platforms, rapid-release pipelines, and automated deployments have reshaped how GxP technologies behave in regulated environments. Digital Validation and Cloud Assurance for SaaS, PaaS and Automated Pipelines under CSA helps teams understand how to maintain control when software changes faster than traditional validation can respond. Companies face real pressure: vendor-driven updates, opaque architecture, limited test evidence, and shared responsibility models that blur accountability. When these challenges collide with data integrity expectations, Part 11 requirements, and risk-based validation principles, the cracks become obvious during audits.

The shift to Computer Software Assurance pushes organizations to focus on what matters — intended use, critical workflows, and measurable risk. Yet many teams still cling to CSV habits that fail under cloud velocity. Digital Validation and Cloud Assurance for SaaS, PaaS and Automated Pipelines under CSA provides the clarity needed to validate SaaS, PaaS, APIs, integrations, and CI/CD pipelines without slowing innovation. By grounding decisions in modern assurance thinking, companies achieve compliance, reliability, and operational confidence. With rising FDA attention on automated systems and cloud vendors, Digital Validation and Cloud Assurance for SaaS, PaaS and Automated Pipelines under CSA becomes essential.

Who This Training Is Designed For

• Quality Assurance (QA)
• Quality Control (QC)
• Regulatory Affairs (RA)
• Validation / Computerized System Validation (CSV)
• Information Technology / Information Systems (IT/IS)
• Cloud Engineering and Automation Teams
• Manufacturing and Production Leadership
• Data Governance and Data Integrity Teams
• R&D and Digital Development Teams
• Lab Informatics and LIMS/ELN Administrators
• Compliance, Audit, and Inspection Readiness Teams
• Design and Software Development Engineers

MODULE 1: The Smart Way to Classify Cloud GxP Systems Before You Validate

January 21, 2026

This course helps teams classify cloud systems accurately before validation begins, using CSA thinking to avoid unnecessary work and eliminate blind spots. It sharpens decision-making around GxP impact, risk, and shared responsibility so validation effort is targeted, defensible, and efficient.

AGENDA:

• FDA’s shift from CSV → CSA
• Identifying GxP systems in modern digital/cloud environments
• Intended Use
• Risk assessment (complexity, criticality, GAMP 5, failure risk)
• CSV foundation (requirements → design → testing → release)
• Why CSV fails in cloud environments
• DI basics (ALCOA+++, raw data integrity)
• Introduction to Shared Responsibility

MODULE 2: The CSA Playbook for SaaS, PaaS & Modern Digital Platforms

January 22, 2026

This course gives teams a clear, practical CSA playbook for SaaS and PaaS systems — how to trust vendors appropriately, verify what matters, and maintain airtight documentation. It simplifies cloud oversight without sacrificing compliance or speed.

AGENDA:

• Cloud architecture explained (simple, GxP-focused)
• SaaS vs PaaS vs IaaS responsibilities
• Vendor audit and oversight
• Leveraging SOC 2, ISO 27001, CSA STAR, wiz.io?
• Supplier testing → assurance mapping
• Documentation expectations for SaaS/PaaS validation
• Intake of vendor updates + change notifications
• Config vs code (critical distinction under CSA)

MODULE 3: How to Validate Automated Pipelines Under CSA

January 23, 2026

This course teaches teams how to validate high-velocity pipelines without losing control of evidence, risk, or audit readiness. It turns CSA principles into clear steps for automated testing, CI/CD oversight, and defensible documentation in digital environments that never stop moving.

AGENDA:

• Why automated pipelines break CSV
• Validating CI/CD, DevOps, rapid-release systems
• Challenge-based testing under CSA
• Automated test evidence
• Bots, scripts & AI-assisted validation
• AI/ML model drift expectations
• Impact analysis for constant updates
• Integrations + APIs + data movement integrity

MODULE 4: Part 11, Data Integrity & Documentation for SaaS/PaaS Validation

January 26, 2026

This course strengthens your Part 11 and data integrity approach for cloud systems, delivering a practical model for documentation, shared controls, and maintaining a validated state through vendor-driven updates.

AGENDA:

• 21 CFR Part 11 for SaaS/PaaS/API-driven systems
• Audit trails, signatures, attribution
• Data integrity risks in cloud environments
• Lightweight CSA documentation package
• Maintaining validated state
• Change management for vendor-driven updates
• Inspection readiness
• What FDA asks during cloud system audits
• Examples from Warning Letters