Part 11, Data Integrity & Documentation for SaaS/PaaS Validation - 3-Hour Course
Description
This 3-Hour 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.
Why This Training Matters:
Cloud systems complicate attribution, audit trails, data movement, and shared controls — all areas inspectors examine closely. CSA Validation and Cloud Assurance helps teams understand how Part 11 applies when vendors host records, automate functions, and push updates that impact validated states. Weak documentation or misplaced assumptions about vendor responsibility often lead to significant findings. A risk-based validation approach grounded in data integrity keeps oversight sharp and defensible. CSA Validation and Cloud Assurance provides a lean, structured model for documentation, change control, and inspection readiness across SaaS and PaaS environments.
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
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
