This course shows teams how to validate fast-moving cloud systems without drowning in outdated CSV practices. It transforms CSA concepts into clear, practical steps that protect data integrity, strengthen Part 11 readiness, and keep SaaS, PaaS, and automated pipelines fully defensible during FDA inspections.
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.
Modules:
- Module 1: The Smart Way to Classify Cloud GxP Systems Before You Validate (January 21, 2026)
- Module 2: The CSA Playbook for SaaS, PaaS & Modern Digital Platforms (January 22, 2026)
- Module 3: How to Validate Automated Pipelines Under CSA (January 23, 2026)
- Module 4: Part 11, Data Integrity & Documentation for SaaS/PaaS Validation (January 26, 2026)
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.
Course Content
Module Details
AGENDA:
AGENDA:
AGENDA:
AGENDA:
Speaker
Carolyn Troiano brings decades of real-world validation leadership across pharma, medical devices, biotech, and other FDA-regulated sectors. She helped shape early CSV approaches, contributed to 21 CFR Part 11 discussions, and has guided global companies through complex system implementations. Her style is practical, clear, and rooted in hands-on experience with modern cloud and CSA expectations.Who Should Attend
- 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
