Do I receive a certificate after completing Part 11, Data Integrity & Documentation for SaaS/PaaS Validation — 3-Hour Course?

Yes, a certificate of completion is included with your registration.

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Recorded WebinarNew

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.

4.9(0 reviews)

3 hours

Instructor

Carolyn Troiano

FDA Compliance & Computer System Validation Consultant

Part 11, Data Integrity & Documentation for SaaS/PaaS Validation — 3-Hour Course

Quantity

Recording – 1 Viewer

$498.00

Buy Now

Secure payment via Stripe

Certificate of completion

What You'll Learn

21 CFR Part 11 requirements for SaaS/PaaS and API-driven systems

Audit trails, electronic signatures, and attribution in cloud environments

Data integrity risks specific to cloud-hosted GxP systems

Lightweight CSA documentation package for cloud validation

Maintaining validated state through vendor-driven updates

Change management for cloud systems and FDA inspection readiness for cloud audits

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

21 CFR Part 11 for SaaS/PaaS and API-Driven Systems

20 min

Audit Trails, Signatures, Attribution in Cloud Systems

20 min

Data Integrity Risks in Cloud Environments

20 min

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.

45+ Years CSV Experience21 CFR Part 11 Co-DeveloperIndependent FDA Consultant

Quantity

Recording – 1 Viewer

$498.00

Buy Now

Secure payment via Stripe

Certificate of completion

Event Details

Format

Recorded Webinar

Duration

3 hours

Certificate

Included

Access

Lifetime

Topics

21 CFR Part 11 Data Integrity SaaS PaaS Cloud Validation CSA Audit Trail ALCOA+

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