Risk-Based Excel Spreadsheet Validation

  • Instructor : Carolyn Troiano
  • Level : Intermediate
  • Study time : 94 minutes
  • Course ID: TF3644
  • Included in Subscription Pack
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ABOUT THE COURSE

Are your Excel spreadsheets GxP-compliant and Part 11 ready?
Do macros or formulas in your sheets expose you to validation risks?
Would your spreadsheet controls survive an FDA audit?


This course shows you how to apply a practical risk-based validation framework to Excel spreadsheets used in FDA-regulated environments — without wasting time or failing compliance checks.


WHAT WILL YOU GAIN
  • Confidence to validate GxP-critical Excel spreadsheets efficiently and correctly
  • Clear understanding of applying SDLC and CSA principles to Excel files
  • Tools to ensure spreadsheet integrity, audit readiness, and 21 CFR Part 11 compliance


WHY TAKE THIS COURSE
  • Spreadsheet failures are a real regulatory risk — and fully preventable
  • You'll learn validation techniques tailored to your workload and risk level
  • Get audit-ready with minimal rework or documentation gaps


KEY AREAS COVERED
  • Risk assessment and validation of Excel spreadsheets used in GxP operations
  • Applying SDLC and Computer Software Assurance (CSA) to spreadsheet compliance
  • Managing macros and custom code as GAMP 5 Category 5 systems
  • Maintaining validated state and documentation throughout the lifecycle
  • Ensuring data integrity and 21 CFR Part 11 compliance in spreadsheet environments
  • Preparing for FDA inspections with the right validation rationale and documentation
This course shows you how to apply a practical risk-based validation framework to Excel spreadsheets used in FDA-regulated environments — without wasting time or failing compliance checks.


WHAT WILL YOU GAIN
  • Confidence to validate GxP-critical Excel spreadsheets efficiently and correctly
  • Clear understanding of applying SDLC and CSA principles to Excel files
  • Tools to ensure spreadsheet integrity, audit readiness, and 21 CFR Part 11 compliance


WHY TAKE THIS COURSE
  • Spreadsheet failures are a real regulatory risk — and fully preventable
  • You'll learn validation techniques tailored to your workload and risk level
  • Get audit-ready with minimal rework or documentation gaps


KEY AREAS COVERED
  • Risk assessment and validation of Excel spreadsheets used in GxP operations
  • Applying SDLC and Computer Software Assurance (CSA) to spreadsheet compliance
  • Managing macros and custom code as GAMP 5 Category 5 systems
  • Maintaining validated state and documentation throughout the lifecycle
  • Ensuring data integrity and 21 CFR Part 11 compliance in spreadsheet environments
  • Preparing for FDA inspections with the right validation rationale and documentation
"

Quality training, expert insights, and answers that matter. Know your Expert

CAROLYN TROIANO

Carolyn Troiano is one of the industry's most experienced voices on computer system validation. With 30+ years in FDA-regulated sectors and direct involvement in shaping 21 CFR Part 11, she’s led countless companies through validation and audit readiness. Her training is sharp, strategic, and built for real-world compliance.

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