Risk-Based Excel Spreadsheet Validation and FDA Compliance - Risk-Based CSV/CSA & Part 11

Overview:

FDA inspections and audits continue to put a bright spotlight on data integrity—especially when organizations rely on tools like Excel to create, calculate, analyze, transfer, or report GxP data. When a spreadsheet influences product quality decisions or regulated records, it can effectively function as a GxP system, and it must be supported by a validation approach that is defendable, risk-based, and inspection-ready.

In this webinar, we’ll walk through a practical, risk-based method for evaluating Excel spreadsheet applications used in FDA-regulated activities and determining the impact of failure on data integrity, process performance, product quality, and patient/consumer safety. You’ll learn how to apply SDLC principles to spreadsheet applications—starting with risk assessment and requirements definition, then moving through streamlined validation planning, testing, documentation, and lifecycle maintenance.

We’ll also clarify how Excel fits within common validation frameworks (including GAMP 5 concepts). For example, a standard installation may be treated differently than a spreadsheet that includes macros or other custom functionality, which increases risk and elevates validation expectations. The session will cover how to plan and execute validation activities—such as IQ/OQ-style evidence where appropriate—while still keeping the effort efficient and focused on proving that the spreadsheet application meets its intended use.

Finally, we’ll connect validation strategy to 21 CFR Part 11 expectations and broader data integrity controls, including the documentation, policies, procedures, and operational practices needed to keep spreadsheet applications in a validated state over time—and to be ready for FDA inspection questions with confidence.

Areas covered in the session:

This webinar includes the following key objectives:

• Learn how to identify spreadsheet applications that are considered to be “GxP” Systems
• Discuss the Computer System Validation (CSV) approach based on FDA requirements to ensure a spreadsheet application will meet requirements and will be suitable for its intended task(s)
• Learn about Computer Software Assurance (CSA) and how this approach may streamline your validation work
• Learn about the System Development Life Cycle (SDLC) approach to validation, and how to apply this to Excel spreadsheet applications
• Discuss the best practices for documenting computer system validation efforts for spreadsheet applications, including requirements, design, development, testing and operational maintenance procedures
• Understand how to maintain a spreadsheet application in a validated state through the system’s entire life cycle
• Learn how to assure the integrity of data that supports GxP work done using the spreadsheet application
• Learn about the policies and procedures needed to support your validation process and ongoing maintenance of your systems in a validated state
• Understand the key components of 21 CFR Part 11 compliance for electronic records and signatures
• Know the regulatory influences that lead to FDA’s current thinking at any given time
• Learn how to conduct a risk assessment on a spreadsheet application that will provide the basis for developing a validation rationale
• Learn how to best prepare for an FDA inspection or audit of a GxP spreadsheet application
• Finally, understand the industry best practices that will enable you to optimize your approach to validating spreadsheet applications, based on risk assessment, to ensure data integrity is maintained throughout the entire data life cycle
• Q&A

Why Should You Attend?

Excel is still one of the most common tools used to support GxP work—yet it’s also one of the easiest places for data integrity and validation gaps to form. If your organization relies on spreadsheets for regulated activities, you need a clear, defensible approach to determine when a spreadsheet becomes a GxP system, what the real risk is, and what evidence FDA will expect to see during an inspection.

This session helps you move from uncertainty and inconsistent practices to a structured, risk-based validation strategy. You’ll learn how to apply SDLC thinking to spreadsheet applications—defining requirements, planning and executing efficient testing, and documenting what matters—so your validation effort is thorough without becoming overly burdensome.

You’ll also walk away with practical guidance on maintaining spreadsheet applications in a validated state over their lifecycle, aligning your approach with 21 CFR Part 11 expectations and current regulatory focus on data integrity. The result: stronger inspection readiness, clearer internal justification for your validation decisions, and a more reliable foundation for GxP data and product quality decisions.

Handouts:

Attendees will gain access to exclusive handouts, including presentation materials provided by the speaker and additional resources developed by Amorit Education to aid your teams in post-session implementation, such as:

• GxP Spreadsheet Validation Decision Kit (PDF)
• Streamlined SDLC Validation Pack for Excel Spreadsheet Applications (PDF)

Industries that will benefit from this 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?

Personnel in the following roles will benefit:

• Information Technology (IT) developers, testers, support resources
• 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