Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR

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Carolyn Troiano

Speaker: Carolyn Troiano

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Date
27 October, 2026 (Tuesday)
Time
12:00 PM PDT | 03:00 PM EDT
Duration
90 Minutes

Overview

Cloud services, SaaS, IaaS, PaaS, software as a medical device and mobile devices all add new questions to computer system validation (CSV). This 90-minute data integrity and 21 CFR Part 11 webinar reviews current technology trends alongside FDA compliance and enforcement.

You'll see why the FDA encourages Computer Software Assurance (CSA) over traditional CSV, and how critical thinking and risk lead the test effort: each requirement is tested according to the risk if it fails. The session also looks at agile vs waterfall development and automated testing.

The trainer covers data integrity, 21 CFR Part 11 for electronic records and signatures, EU Annex 11, the General Data Protection Regulation (GDPR) and related requirements. You'll walk through the validation process, common pitfalls and industry best practices, and how to keep a regulated system in a validated state across its life cycle.

Area Covered

  • Identifying GxP systems and the right type and level of validation
  • The computer system validation (CSV) approach based on FDA requirements
  • The system development life cycle (SDLC) approach and how to adapt it to alternatives such as Computer Software Assurance (CSA), covered in FDA draft guidance
  • ISPE GAMP 5 guidance: categorizing software and testing based on risk
  • COTS, functionally configurable and custom-coded systems and FDA requirements
  • Cloud computing and SaaS, and the best approach to validating them
  • Keeping a system in a validated state through its entire life cycle
  • Policies and procedures that support validation and ongoing maintenance
  • Key components of 21 CFR Part 11 for electronic records and signatures, and EU Annex 11
  • The regulatory influences behind FDA's current thinking
  • Preparing for an FDA inspection or audit of a GxP computer system
  • Why a thorough vendor audit matters for oversight of products and services
  • Industry best practices for risk-based validation that protects data integrity across the data life cycle
  • Q&A

Why Should You Attend

Validation approaches built for on-premise, custom software often struggle with cloud, SaaS and agile delivery. This session shows how to apply risk-based thinking so validation effort protects data integrity, product quality and patient safety.

It is meant for people who plan, run or support computer system validation in FDA-regulated industries, including pharmaceutical, medical device, biologics, tobacco and tobacco-related products. Relevant functions include R&D, manufacturing, quality control, distribution, clinical testing, labeling, adverse events and post-marketing surveillance.

Who Will Benefit?

  • Information Technology Developers, Analysts, Testers, and Support Personnel
  • QC/QA Analysts, Supervisors, and Managers
  • Clinical Data Scientists, Supervisors, and Managers
  • Analytical Chemists, Supervisors, and Managers
  • Compliance Specialists and Managers
  • Laboratory Personnel, Managers, and Supervisors
  • Manufacturing Personnel Managers, and Supervisors
  • Supply Chain Specialists
  • Computer System Validation Specialists
  • GMP Training Specialists
  • Business Stakeholders responsible for computer system validation planning, execution, reporting, compliance, maintenance, and audit
  • Consultants working in the life sciences industry who are involved in computer system implementation, validation, and compliance
  • Auditors engaged in the internal inspection of labeling records and practices

Speaker

Carolyn Troiano has more than 35 years of experience in computer system validation in the tobacco, pharmaceutical, medical device and other FDA-regulated industries. She has worked directly, or on a consulting basis, for many of the larger pharmaceutical and tobacco companies in the US and Europe. She is currently building an FDA computer system validation compliance strategy at a vapor company. Carolyn has participated in industry conferences, and is currently active in the Association of Information Technology Professionals (AITP), and Project Management Institute (PMI) chapters in the Richmond, VA area. Carolyn also volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

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