Risk-based Excel Spreadsheet Validation

Description

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…