Excel Spreadsheet Validation for FDA 21 CFR Part 11

Federal & State Resources

Date posted: 02/22/16

This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application. Areas Covered in the Webinar: 1. Requirements for Excel Spreadsheets 2. FDA Part 11 Validation Guidance 3. Compliance Problems with Spreadsheets 4. Design Specifications for 21 CFR 11 compliance 5. How does the FDA Design and Use spreadsheets 6. Documentation for Part 11 7. Future Trends in 21 CFR 11 compliance for Excel Spreadsheets Who Will Benefit: 1. Quality Managers 2. Quality Engineers 3. Small business owners 4. Internal and external auditors 5. Management Reps 6. FDA inspectors 7. Consultants