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