Excel Spreadsheet in FDA Regulated Environment

Overview:

The use of Excel in FDA-regulated environments goes far beyond basic analysis. When spreadsheets touch GxP data—batch calculations, QC results, stability trending, complaint tracking, or clinical data listings—they become part of your quality system and must hold up to inspection. Recent FDA activity reinforces this: inspection-observation datasets for FY 2024 continue to cite records and data-control issues that often surface when spreadsheets are uncontrolled, unvalidated, or lack adequate traceability.

Real cases from 2024–2025 show the typical failure modes. In one 2025 warning letter, FDA cited a manufacturer for using an unvalidated Excel spreadsheet to calculate final concentrations; when batch sizes changed, the unvalidated formula path created risk of sub- or super-potent product—an avoidable problem had the spreadsheet been validated and verified against specifications. Across multiple letters and 483 themes, investigators continue to note gaps such as missing or incomplete audit trails, uncontrolled “master” workbooks, weak permission settings that allow undetected edits, and lack of documented verification of critical formulas—each of which undermines data reliability in a Part 11 context.

This webinar stays focused on those fundamentals. We’ll decode how to build and validate GxP-compliant spreadsheet applications using Excel’s native features (no macros required), show practical configurations for security, versioning, cell/file protection, input checks, and an inspectable change history, and walk through right-sized validation so critical calculations are verified without bloating documentation. We’ll also align terminology with FDA expectations around electronic records and signatures (21 CFR Part 11) and the role of audit trails in reconstructing “who, what, when, and why” for any record change—so your spreadsheets can withstand scrutiny and help you avoid avoidable 483s and Warning Letters.

Areas covered during the session include:

• Developing GxP compliant spreadsheet applications
• Utilizing Excel's built-in 21 CFR Part 11 features
• Apply features required for GxP environments without programming macros.
• Configuring Excel for audit trails, security features, data verification, and multiple concurrent users
• Avoid 483s and Warning Letters
• Implementing cell and file protections
• Understanding the validation scope and minimizing documentation
• Understand what does and does not need to be validated.
• Specifying and testing your application
• Q&A

Learning Objectives:

Why are spreadsheets so popular?

• Spreadsheet overview
• What are they used for?

Why is compliance a problem?

• How is it different from a calculator?

Developing Part 11 applications

• Security
• Versioning
• Cell protection
• Data entry checks
• Audit trail
• Data output formatting

Validation

• Fill-in-the-blank validation templates
• Step-by-step validation

Using the validated application

• Maintaining, upgrading, re-validation

Examples

• Requirements
• Specifications
• Test cases

How to turn on the audit trail

• How to view the audit trail

Why should you attend?

If your teams use Excel anywhere in GxP workflows, this session focuses on the essentials you can apply immediately: how to configure spreadsheets for audit trails, security, controlled access, versioning, and data-entry checks—using native Excel features, with no macros required.

You’ll learn a clear, step-by-step approach to specifying, testing, and validating critical calculations so your spreadsheets are consistent, traceable, and aligned with 21 CFR Part 11 expectations. We’ll show how to right-size documentation so you protect quality and integrity without unnecessary effort.

Attending helps you reduce avoidable issues that lead to 483s and Warning Letters, standardize a repeatable method your team can follow, and keep Excel a safe, efficient tool in your FDA-regulated environment.

Who will benefit?

This webinar is designed for professionals who regularly use Excel in GxP regulated environments, such as:

• Quality Assurance and Quality Control Managers
• Data Management and Statistics Professionals
• Regulatory Affairs Professionals
• Compliance Officers
• Laboratory Managers
• Validation Specialists
• IT Professionals in the Pharma, Biotech, and Medical Device Industries
• Clinical Data Managers and Scientists
• Analytical Scientists
• Any professional keen on enhancing their Excel competency and understanding of its use in an FDA-regulated environment.

Whether you're responsible for creating or validating spreadsheet applications, managing product compliance, or overseeing data management in clinical trials, this webinar can enhance your proficiency and ensure your work aligns with FDA regulations.

ABOUT PRESENTER:

David Nettleton Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU General Data Protection Regulation (GDPR), software validation, and computer system validation.

Mr. Nettleton is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 300 mission critical laboratory, clinical, and manufacturing software implementation projects.

Mr. Nettleton recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.

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.

Please be aware that, this particular webinar will not be recorded and will not be available for viewing after the live event has concluded. Therefore, we encourage you to attend the live event to gain full access to the information presented.