Best Practices in Preparation for an FDA Computer System Audit

Overview:

In 2025, the FDA's expectations for validated computer systems have never been higher—or more closely watched. Whether you’re in pharmaceuticals, biotech, medical devices, or clinical research, if your systems support GxP activities—like production, quality management, lab data handling, or clinical trial operations—then you can expect them to be audited and inspected. And when the FDA walks through your doors, they’ll be looking for more than just a validation plan—they’ll expect to see complete, risk-based, real-world evidence that your system works as intended, protects data integrity, and complies with regulatory standards.

This session is designed to help you get there. We’ll walk you through exactly what the FDA wants to see during a computer system inspection, how those expectations have changed in recent years, and what audit-readiness really looks like in today’s landscape. Whether your audit is internal, driven by a third party, or part of an official FDA inspection, the preparation approach must be the same: proactive, structured, and risk-informed.

We’ll begin by examining the current state of Computer System Validation (CSV)—the traditional, documentation-driven approach—and why it’s still a cornerstone of compliance. But we’ll also explore how new technologies, evolving software development practices, and the rise of cloud-based platforms have made it more difficult to apply CSV in a one-size-fits-all way. That’s where the FDA’s draft guidance on Computer Software Assurance (CSA), released in September 2022, comes into play.

CSA offers a more flexible, modern validation approach that prioritizes critical thinking, system risk, and intended use over exhaustive documentation. While it’s still in draft form as of mid‑2025, many companies are already using CSA principles to streamline validation efforts—especially when it comes to production and quality system software. We’ll also tie in GAMP®5, 2nd Edition, which provides a practical framework for applying CSA and supports both Agile and Waterfall development methodologies.

But understanding CSA and CSV is only part of the story. To be fully audit- and inspection-ready, you also need to anticipate how the FDA will evaluate your systems in practice. That means understanding their inspection process, knowing what triggers their attention, and preparing the right documentation and controls in advance. We’ll cover real-world FDA findings and recent enforcement trends, showing where companies often fall short—and how you can avoid those same pitfalls.

We’ll also discuss data integrity in depth, including how the FDA continues to enforce the ALCOA+ principles: making sure your data is attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, and available. If your systems involve third-party vendors, SaaS platforms, or cloud services, you’ll learn how to maintain oversight and ensure your validation, access control, and archival practices are defensible during an inspection.

Throughout the session, we’ll bring the theory into real-world focus: how to plan, document, and rehearse for an FDA system audit; how to structure your risk assessments; how to organize your audit room and inspection day logistics; and how to prepare your team to respond confidently to investigator questions.

Whether you’re building your validation strategy from scratch or looking to upgrade existing systems to align with FDA expectations, this webinar will give you the clarity, tools, and forward-looking insight needed to navigate your next audit or inspection with confidence—and come out ahead.

Areas covered during the session:

• Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
• Computer Software Assurance (CSA), Draft Guidance from FDA issued September 2022
• GAMP®5, 2nd Edition, published by ISPE in July 2022, and alignment with CSA
• Waterfall and Agile, as Software Development, Testing, and Release Life Cycle Methodologies
• “GxP” – Good Manufacturing, Laboratory and Clinical Practices
• 21 CFR Part 11, Electronic Records/Electronic Signatures (ER/ES)
• Data Integrity and the “ALCOA+” Principles (attributable, legible, contemporaneous, original or “true copy,” accurate, complete, consistent, enduring, and available)
• Data Archival and Governance to ensure security, integrity and compliance
• Validation Strategy that will take into account the system risk assessment and system categorization (GAMP®5) processes
• Recent FDA findings and citations for companies in regulated industries
• The resources, documentation and room preparation necessary to adequately prepare for FDA inspection
• Q&A

Handouts included:

Attendees will receive two exclusive downloadable handouts, including:

• FDA Computer System Inspection Preparation Checklist
• CSV vs. CSA Comparison Quick Reference Guide

Why Should You Attend?

If your company relies on computer systems to support GxP activities, you’re already operating in a high-risk compliance environment. FDA inspections can happen with little notice, and when they do, your validation practices, documentation, and system controls will be under the microscope. This webinar will help you understand what the FDA looks for—so you’re not scrambling to respond when that day comes.

You’ll gain clarity on the difference between traditional CSV and the newer CSA approach, and learn how to apply the right validation strategy based on your system’s risk, function, and regulatory exposure. Whether you're overseeing a cloud-based platform, legacy infrastructure, or a newly developed software solution, you'll leave with practical methods for preparing your systems for scrutiny.

Most importantly, this session will walk you through what real inspection readiness looks like—how to plan, what to document, how to communicate, and how to ensure your systems, your team, and your records all stand up to FDA expectations.

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?

• Information Technology Analysts
• QC/QA Managers
• QC/QA Analysts
• Clinical Data Managers
• Clinical Data Scientists
• Analytical Chemists
• Compliance Managers
• Laboratory Managers
• Automation Analysts
• Manufacturing Managers
• Manufacturing 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

ABOUT PRESENTER:

Carolyn Troiano has more than 40 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation

Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

NOTE FOR ATTENDEES:

Live attendees will receive a WebEx meeting invitation upon successfully completing the registration.

Please note that if you have registered two or more attendees, each participant will receive their own WebEx invitation from the organizer at a later time. The registered user will receive an email from the organizer requesting details for all other participants.

Participants who have opted for the recorded version of the program will receive a WebEx link within 8 hours after the event's completion. Using this link, participants can view or download the event at their convenience.