- GxP spreadsheet identification and inventory management
- Risk assessment for determining validation scope
- CSV versus CSA approaches for spreadsheet assurance
- SDLC application to spreadsheet design and testing
- Requirements, testing evidence, and lifecycle documentation
- Data integrity and 21 CFR Part 11 considerations
- Maintaining validated spreadsheets through change and ongoing use
- FDA inspection preparation for GxP spreadsheet applications
When Excel supports GxP activities, teams must determine which spreadsheets require validation, how much testing is appropriate, and which controls must remain active.
This session structures a risk-based approach to spreadsheet assessment, validation planning, testing, documentation, lifecycle maintenance, and electronic records compliance.
The session moves from spreadsheet classification and inventory into validation planning, testing, and lifecycle control. It distinguishes standard Excel use from customized applications, examines CSV and CSA approaches, and connects requirements, system suitability, data integrity, maintenance, and inspection preparation into a practical validation process.
Carolyn Troiano brings more than 45 years of computer system validation experience across FDA-regulated industries. Her work in CSV, data integrity, large-scale system implementation, and 21 CFR Part 11 development provides direct context for evaluating spreadsheet risk, selecting appropriate validation activities, and maintaining Excel applications in a controlled state throughout their GxP lifecycle.