Risk-based Excel Spreadsheet Validation - 2026 Updates

Discover the latest strategic approach and best practices for evaluating Excel spreadsheets used in FDA-regulated activities in 2026. 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. Additionally, gain insights into industry best practices, focusing on data integrity and risk assessment, to enhance your GxP operations.

| AREAS COVERED

• Identifying when Excel spreadsheets become GxP systems
• Creating a spreadsheet inventory to create simple templates with extended capabilities
• CSV vs CSA — choosing the right validation approach
• Applying the SDLC to spreadsheet design and testing
• Documentation essentials — requirements, testing, and maintenance
• Keeping spreadsheets in a validated state across their lifecycle – clarity of roles/responsibilities
• Ensuring data integrity and Part 11 compliance in Excel
• Conducting a practical, risk-based assessment for spreadsheet validation
• Preparing for FDA inspections of GxP spreadsheet applications

| WHO SHOULD ATTEND

• Information Technology (IT) Analysts
• IT Developers
• IT Support Staff
• IT Security Staff
• QC/QA Managers and Analysts
• Production Managers and Supervisors
• Supply Chain 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
• Interns working at the companies listed above

Course Director: Carolyn Troiano

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. During her career she has provided training, including CSV, 21 CFR Part 11, Data Integrity, and many other related compliance topics of interest to the life science industries.