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Risk-based Excel Spreadsheet Validation - 2026 Updates

Master risk-based Excel spreadsheet validation for FDA-regulated environments — covering GAMP 5, SDLC, 21 CFR Part 11, data integrity, and inspection readiness.

4.8(0 reviews)
90 minutesFriday, September 4, 2026
Carolyn Troiano

Instructor

Carolyn Troiano

FDA Compliance & Computer System Validation Consultant

What You'll Learn

Identify when Excel spreadsheets become GxP systems requiring formal validation
Apply the correct GAMP 5 category (1 vs. 5) to Excel-based tools and understand the validation implications
Choose between CSV and CSA approaches based on risk and intended use
Apply the SDLC to spreadsheet design, testing, and maintenance
Define and document requirements, testing protocols, and system suitability criteria
Ensure 21 CFR Part 11 compliance for electronic records and signatures in Excel
Conduct a practical, risk-based assessment for spreadsheet validation
Keep spreadsheets in a validated state across their full lifecycle with clear role definitions
Prepare for FDA inspections of GxP spreadsheet applications

About This Event

Discover the strategic approach and best practices for evaluating Excel spreadsheets used in FDA-regulated activities. We'll assess the potential risks associated with spreadsheet failures on data integrity, process quality, and safety. Explore the System Development Life Cycle (SDLC) validation approach, emphasizing risk assessment, and delve into the significance of managing electronic records and signatures according to 21 CFR Part 11. Our webinar will guide you through the validation process for Excel spreadsheets used in FDA-regulated tasks. Excel, categorized as a GAMP 5 Category 1 system during installation, must be handled with precision. However, once macros or custom functionalities are added, it becomes a GAMP 5 Category 5 system, necessitating validation to ensure accurate coding. We'll detail the planning and validation activities required for custom Excel applications. While full validation, including Installation Qualification (IQ) and Operational Qualification (OQ), is essential, we'll streamline the process. Learn how to define and test requirements, incorporate system suitability with input from Subject Matter Experts (SMEs), and ensure compliance with FDA validation, Part 11, and data integrity requirements. Explore the creation of essential policies, procedures, and supporting documentation for spreadsheet compliance. Maintain your validated spreadsheet application effectively and prepare for FDA inspections with our insights. Code: FDB3644

Curriculum

Identifying GxP Excel Spreadsheets and Creating a Spreadsheet Inventory
20 min
GAMP 5 Category 1 vs. Category 5 — What Changes When Macros Are Added
15 min
CSV vs. CSA — Choosing the Right Validation Approach for Spreadsheets
15 min

Requirements

  • IT, QA, QC, or validation professionals in FDA-regulated industries working with Excel-based tools
  • Applicable to computer system validation specialists, compliance managers, lab managers, and business stakeholders using GxP spreadsheets

Who Should Attend

Information Technology (IT) Analysts, IT Developers, IT Support Staff, QC/QA Managers and Analysts, Production Managers and Supervisors, Clinical Data Managers and Scientists, Compliance Managers and Auditors, Lab Managers and Analysts, Computer System Validation Specialists, GMP/GLP/GCP Training Specialists, Business Stakeholders using Computer Systems regulated by FDA, Regulatory Affairs Personnel, Consultants in the Life Sciences and Tobacco Industries.

Areas Covered

Identifying when Excel spreadsheets become GxP systems
GAMP 5 Category 1 vs. Category 5 classification
CSV vs CSA — choosing the right validation approach
SDLC application to spreadsheet design and testing
Documentation essentials — requirements, testing, and maintenance
Lifecycle management — roles, responsibilities, and change control
21 CFR Part 11 and data integrity compliance in Excel
Risk-based assessment for spreadsheet validation
FDA inspection readiness for GxP spreadsheet applications

Meet Your Instructor

Carolyn Troiano

Carolyn Troiano

FDA Compliance & Computer System Validation Consultant

Carolyn Troiano has more than 45 years of experience in computer system validation in the pharmaceutical, medical device, biotechnology, tobacco, and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, Computer System Validation (CSV), and large-scale IT system implementation projects. Carolyn participated in the FDA/Industry Partnership to develop 21 CFR Part 11, the FDA's Guidance for Electronic Records and Electronic Signatures.

45+ Years CSV Experience21 CFR Part 11 Co-DeveloperIndependent FDA Consultant
Quantity
1

Single Access

$240.00
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Certificate of completion

Event Details

Format

Live Webinar

Duration

90 minutes

Certificate

Included

Date

Friday, September 4, 2026

Topics

Excel ValidationCSVCSAGAMP 521 CFR Part 11Data IntegrityGxPRisk-Based ApproachFDASDLCValidation

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