Change Control for SaaS and AI Systems

Description Traditional change control processes were designed for static, on-premise systems with infrequent updates. Today's SaaS platforms and AI-enabled applications operate in a rapidly evolving environment where software updates, configuration changes, vendor releases, model updates, integrations, and cloud infrastructure modifications occur continuously. Organizations must maintain compliance and validated states without creating overwhelming validation backlogs or slowing innovation. This webinar provides a practical, risk-based framework for managing change in SaaS and AI systems while maintaining regulatory compliance and inspection readiness. Participants will learn how to identify and control configuration drift, assess the impact of vendor-driven changes, determine when revalidation is required, and implement efficient change management strategies that align with FDA CSA principles, GAMP® 5 Second Edition guidance, and modern regulatory expectations for computerized systems and AI-enabled technologies. LEARNING OBJECTIVES: By the end of this session, attendees will be able to: • Learn how to maintain compliance without treating every SaaS update as a full revalidation effort. • Understand how to implement risk-based change control processes that support both compliance and business agility. • Gain practical methods for identifying and controlling configuration drift before it creates compliance risks. • Develop defensible criteria for determining when testing, revalidation, or documentation updates are necessary. • Reduce validation bottlenecks that consume resources and delay system improvements. • Improve oversight of vendor-managed and AI-driven changes while maintaining accountability. • Align your change management practices with FDA CSA principles, GAMP 5 guidance, and current industry expectations. • Strengthen your organization's ability to adopt cloud and AI technologies confidently while remaining inspection-ready. • Receive practical tools and approaches that can be immediately applied to regulated SaaS and AI environments. AREAS COVERED: • Regulatory expectations for change control in SaaS, cloud-based, and AI-enabled systems • Applying FDA Computer Software Assurance (CSA) principles to change management activities • GAMP® 5 Second Edition guidance on modern change and lifecycle management • Understanding configuration drift and its impact on validated systems • Differentiating vendor-controlled, customer-controlled, and shared-responsibility changes • Risk-based impact assessments for SaaS releases, patches, and feature updates • Managing AI model updates, retraining activities, and algorithm changes • Determining when revalidation, regression testing, or documentation updates are required • Establishing scalable approval workflows for high-frequency system changes • Leveraging vendor documentation, release notes, and assurance evidence • Maintaining traceability and validation status in continuously evolving systems • Change control strategies for integrations, APIs, middleware, and connected platforms • Metrics and governance approaches to prevent change and validation backlogs • Inspection readiness considerations and documentation expectations • Case studies demonstrating effective management of SaaS and AI system changes WHO SHOULD ATTEND: • Quality Assurance Departments • Validation and CSA Practitioners • IT and Digital Transformation Leaders • System Owners • Data Integrity Specialists • Compliance Managers • CSV Professionals • AI Governance Teams • Regulatory Affairs Departments • Everyone responsible for maintaining compliant and validated cloud-based and AI-enabled systems. Course Director: CAROLYN TROIANO 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 consulting and training, including CSV, 21 CFR Part 11, Data Integrity, and many other related compliance topics of interest to the life science industries.