LIVE WEBINAR

Excel Spreadsheets – Ensuring Data Integrity and

21 CFR Part 11 Compliance

ABOUT THE COURSE

Excel workbooks often support GxP decisions without clear configuration standards, leaving teams to determine what truly requires validation and documented controls. This session establishes a structured approach to configuring spreadsheet applications with built-in controls, aligning security, auditability, and validation scope to 21 CFR Part 11 expectations.

The session follows a stepwise configuration of a working spreadsheet, demonstrating security settings, audit trail activation, and data verification controls in real time. It then connects those configurations to validation planning, specification writing, and testing decisions so documentation remains proportionate and clearly justified.

Designed for professionals responsible for electronic records integrity and controlled spreadsheet use within regulated environments.

KEY AREAS COVERED

How to develop GxP compliant spreadsheet applications
Learn how to use Excel’s built in 21 CFR Part 11 features
Apply features required for GxP environments without programming macros.
Follow along as we configure Excel for audit trails, security features, data verification, and multiple concurrent users
Avoid 483s and Warning Letters
How to use cell and file protections
Reduce validation time and costs
Increase compliance while lowering resource needs
Validate your application with minimal documentation
Understand what does and does not need to be validated.
How to specify and test your application

Course Director

David Nettleton

David Nettleton is an FDA compliance specialist focused on 21 CFR Part 11 and computer system validation. With more than 185 software validation projects completed, he brings practical experience configuring and validating regulated applications. His work in gap analysis, remediation, and risk-based validation directly supports controlled spreadsheet implementation in GxP environments.

FDB3451

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