Description
Why should you Attend
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. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.
Areas Covered in the Session
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
Quality Managers
Quality Engineers
Small business owners
Internal and external auditors
Management Reps
FDA inspectors
Consultants
Why should you Attend
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. However, the FDA expects that spreadsheets be compliant and lack of compliance can result in a warning letter. Consequently, validation of Excel Spreadsheet Applications is required as part of a 21 CFR 11 compliant environment.
Areas Covered in the Session
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
Quality Managers
Quality Engineers
Small business owners
Internal and external auditors
Management Reps
FDA inspectors
Consultants
