Validation and Use of Excel® Spreadsheets in Regulated Environments 2012

Key Topics

• How to design spreadsheets for part 11/GxP/SOS/HIPAA compliance
• FDA and other agency’s requirements for spreadsheet validation - What do inspectors ask and what documents should be available
• When, what and how much to test?
• Validation during design, development, installation and on-going use
• How to ensure and validate spreadsheet integrity for GxP and part 11?
• Dealing standard Excel functions: Recommendations from GAMP® 5
• Validation of `ad hoc` spreadsheet applications
• How to apply risk based validation to spreadsheet applications
• How to document planning, specifications, installation, testing and changes
• How to ensure spreadsheet security and integrity for Part 11 and EU Annex 11

The Validation and Use of Excel® Spreadsheets in Regulated Environments brings together All developers and users of spreadsheet applications, Pharmaceutical and medical device industry, QA managers and personnel, Validation specialists, Production and lab managers, Regulatory affairs, Documentation department, Training department and Consultants.