Why take this course?
Cloud and digital GxP systems have changed how validation decisions are made, especially where single-tenant, multi-tenant, and SaaS models shift technical control away from the regulated company. FDA has regulated computer system validation for decades, and 21 CFR Part 11 established the baseline expectations for electronic records and electronic signatures in regulated environments. What has become harder is determining validation scope, ownership, and evidence when the system is not on-premise and the provider controls much of the infrastructure.
A risk-based approach remains central. System size, complexity, business criticality, GAMP®5 category, and risk rating drive how much testing is needed to protect data integrity and product safety. This requires a structured decision process, supported by SDLC thinking and system qualification tools, so validation rationale is tied to actual system use rather than generic templates. The distinction between CSV and CSA also matters, particularly where streamlined testing is appropriate but accountability remains unchanged. This program focuses on cloud-specific validation planning, supplier oversight, and inspection readiness.
Key Areas Covered
Carolyn Troiano
Carolyn Troiano has more than 45 years of experience in computer system validation across pharmaceutical, medical device, biotechnology, tobacco, and other FDA-regulated industries. She has advised companies on FDA compliance, CSV, and large-scale IT implementations, and participated in the FDA/Industry Partnership that developed 21 CFR Part 11 for electronic records and electronic signatures.
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