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GAMP Microlearning: Validation and Data Integrity for Spreadsheets and End User Applications

GAMP® Microlearning: Validation and Data Integrity for Spreadsheets and End User Applications

ISPE has created mirolearning offerings based on the GAMP® Basic Principles (T45) training course.  This section focuses on Spreadsheets. The "Validation and Data Integrity for Spreadsheets and End User Applications" section of the GAMP® Basic Principles (T45) training course addresses the unique risks and regulatory expectations associated with spreadsheets and other end-user developed tools in GxP environments. Participants learn how these tools, while convenient and powerful, often lack formal controls, posing significant data integrity risks. The module explores common FDA warning letter findings, spreadsheet components, and the challenges of ensuring accuracy, reliability, and security. A risk-based approach is emphasized, with validation and control strategies tailored to the complexity and GxP impact of the application. Learners examine use cases ranging from simple calculations to complex macros, and gain practical guidance on procedural and technical controls, including when replacement with a formal application may be warranted.
165.00