Future Trends in 21 CFR 11 compliance for (Excel Spreadsheets)

Overview: Spreadsheet Applications such as MS Excel are frequently used in 21 CFR 11 compliant environments, but they were not specifically designed for regulated environments and their development is not optimized for 21 CFR 11 compliance. Areas Covered in the Session: Requirements for Excel Spreadsheets FDA Part 11 Validation Guidance Compliance Problems with Spreadsheets Design Specifications for 21 CFR 11 compliance Documentation for Part 11 Who Will Benefit: Quality Managers Quality Engineers Small Business Owners GxP Consultants