Data Integrity and Data Governance for Computer Systems Regulated by FDA in 2025

Overview:

As regulatory scrutiny intensifies, data integrity and governance have become cornerstone issues for companies operating within FDA-regulated environments—particularly those relying on computerized systems to manage critical GxP processes. Ensuring data is accurate, complete, and secure across its lifecycle is not only a regulatory requirement but a business imperative, as compliance gaps can result in costly warning letters, product recalls, or even criminal liability.

This webinar offers a deep exploration into the dual pillars of Data Integrity (DI) and Data Governance (DG), and how they intersect with the FDA’s expectations around Computer System Validation (CSV). Whether you're involved in manufacturing, clinical trials, or laboratory operations, the integrity of your data—and the systems managing that data—plays a pivotal role in product quality and patient safety.

We will walk you through the FDA’s evolving approach to data oversight, highlighting practical strategies to establish a robust data governance framework that supports compliance, reduces risk, and enhances operational efficiency. The session will clarify how CSV ties into DI assurance, offering detailed insights into key components like risk-based validation, the GAMP 5 “V” Model, and software categorization, all of which serve as critical foundations for system reliability and data trustworthiness.

Moreover, as digital technologies evolve—introducing cloud systems, automation, and AI—the stakes for governance grow higher. This webinar will cover essential elements such as access control, audit trails, disaster recovery, and business continuity—all tailored to reflect modern challenges. Attendees will also gain actionable guidance on how to sustain a validated state across the system lifecycle, from development through retirement, with a strong focus on policy enforcement, staff training, and change management.

Whether you’re initiating a new system or auditing your existing environment, this session will equip you with the tools to ensure that your data isn’t just technically compliant but fundamentally trustworthy—a key differentiator in today’s risk-conscious regulatory landscape.

Areas covered in the session:

• Computer System Validation (CSV)
• System Development Life Cycle (SDLC) Methodology
• Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
• Data Integrity (DI)
• Data Governance (DG)
• Validation Strategy, Planning and Execution
• System Risk Assessment
• GAMP 5 “V” Model and Software Categorization
• 21 CFR Part 11, FDA’s Guidance on Electronic Records/Electronic Signatures (ER/ES)
• Security, Access, Change Control and Audit Trail
• Criteria required to ensure data is created and maintained with integrity through its life cycle
• Policies and Procedures to support CSV and DI assurance
• Training and Organizational Change Management
• Current FDA Trends in Compliance and Enforcement
• Industry Best Practices and Common Pitfalls
• Q&A

Why should you attend?

This webinar offers a focused and practical overview of how data integrity and governance principles apply to computer systems subject to FDA regulation. If you’re involved in validation, quality assurance, or compliance functions, attending this session can help you better understand the FDA’s expectations and how to align your systems accordingly.

You’ll gain insight into how data governance connects with system validation and what measures are needed to ensure data remains accurate, consistent, and trustworthy across its lifecycle. Topics like GAMP 5, system risk assessment, and the role of supporting policies and procedures will also be explored.

Whether you’re maintaining an existing system or preparing for upcoming changes, this session will offer clear guidance on strengthening your compliance practices and keeping your systems in a state of readiness.

What industries will benefit from your training?

Manufacturing, Testing, Packaging and Distribution companies in the following industries that are regulated by FDA are required to follow GxPs:

• Pharmaceutical (for drug products introduced using a medical device)
• Medical Device
• Biologicals (for biological products introduced using a medical device)
• Tobacco (based on the Tobacco Control Act of 2009)
• E-Liquid/Vapor (based on the “Deeming” Act of 2016)
• E-Cigarette (based on the “Deeming” Act of 2016)
• Cigar (based on the “Deeming” Act of 2016)
• Third-Party companies that support those in the above industries, including Contract Research Organizations (CROs)
• Colleges and Universities offering programs of study in Clinical Trial Management and Regulatory Affairs/Matters related to FDA

Who Will Benefit?

This webinar is ideal for professionals responsible for maintaining compliance of FDA-regulated computer systems and ensuring data integrity across the organization. Those include:

• Quality Assurance Managers
• Regulatory Affairs Professionals
• Validation Engineers
• Compliance Officers
• IT Managers and System Administrators
• Data Integrity Specialists
• Documentation and Records Managers
• Manufacturing and Operations Managers
• Clinical and Laboratory QA Professionals
• R&D and Product Development Staff
• CSV Consultants
• Internal Auditors
• Training and Change Management Leads
• GxP Professionals in the Life Sciences Industry