Part 11, Data Integrity & Documentation for SaaS/PaaS Validation — 3-Hour Course
A 3-hour deep dive into 21 CFR Part 11 and data integrity for SaaS/PaaS cloud systems — covering audit trails, shared responsibility, change management, and FDA inspection readiness.
Instructor
Carolyn Troiano
FDA Compliance & Computer System Validation Consultant
What You'll Learn
About the event
About this event
Cloud systems complicate attribution, audit trails, data movement, and shared controls — all areas inspectors examine closely. 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.
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.
This is Module 4 of the Practitioner Course "Digital Validation and Cloud Assurance: Validating SaaS, PaaS and Automated Pipelines under CSA."
Code: SEM13454
Curriculum
Requirements
- QA, QC, Regulatory Affairs, Validation, IT, and Cloud Engineering professionals
- Applicable to data governance teams, lab informatics administrators, and compliance teams
Meet Your Instructor
Carolyn Troiano
FDA Compliance & Computer System Validation Consultant
Carolyn Troiano has more than 45 years of experience in computer system validation in the pharmaceutical, medical device, biotechnology, tobacco, and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, Computer System Validation (CSV), and large-scale IT system implementation projects. Carolyn participated in the FDA/Industry Partnership to develop 21 CFR Part 11, the FDA's Guidance for Electronic Records and Electronic Signatures. During her career she has provided training on CSV, 21 CFR Part 11, Data Integrity, and many other compliance topics of interest to the life science industries.
Event Details
Format
Recorded Webinar
Duration
3 hours
Certificate
Included
Access
Lifetime
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