This interactive webinar explains how to configure and validate GxP-compliant spreadsheet applications to avoid FDA 483s. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. Understand how to validate your application with minimal documentation. Bring your laptop and use Excel for your own needs. This session will make you a better Excel user, saving you time and costs.
WHY SHOULD YOU ATTEND?
- Develop spreadsheet applications that are GxP-compliant.
- Learn how to use Excel’s built-in 21 CFR Part 11 features.
- Apply features required for GxP environments without programming macros.
- Follow along as we configure Excel for audit trails, security features, data verification, and multiple concurrent users.
- Avoid 483s and Warning Letters.
- How to use cell and file protections.
- Reduce validation time and costs.
- Increase compliance while lowering resource needs.
- Validate your application with minimal documentation.
- Understand what does and does not need to be validated.
- How to specify and test your application.
LEARNING OBJECTIVES
1. Why are spreadsheets so popular?
- Spreadsheet overview.
- What are they used for?
2. Why is compliance a problem?
- How is it different from a calculator?
3. Developing Part 11 applications.
- Security.
- Versioning.
- Cell protection.
- Data entry checks.
- Audit trail.
- Data output formatting.
4. Validation.
- Fill-in-the-blank validation templates.
- Step-by-step validation.
5. Using the validated application.
- Maintaining, upgrading, re-validation.
6. Examples.
- Requirements.
- Specifications.
- Test cases.
7. How to turn on the audit trail.
- How to view the audit trail.
WHO WILL BENEFIT?
- All Excel users.
- IT.
- QA.
- QC.
- Laboratory staff.
- Managers.
- Executives.
- Auditors.
- GMP, GCP, GLP, regulatory professionals.
- Develop spreadsheet applications that are GxP-compliant.
- Learn how to use Excel’s built-in 21 CFR Part 11 features.
- Apply features required for GxP environments without programming macros.
- Follow along as we configure Excel for audit trails, security features, data verification, and multiple concurrent users.
- Avoid 483s and Warning Letters.
- How to use cell and file protections.
- Reduce validation time and costs.
- Increase compliance while lowering resource needs.
- Validate your application with minimal documentation.
- Understand what does and does not need to be validated.
- How to specify and test your application.
1. Why are spreadsheets so popular?
- Spreadsheet overview.
- What are they used for?
2. Why is compliance a problem?
- How is it different from a calculator?
3. Developing Part 11 applications.
- Security.
- Versioning.
- Cell protection.
- Data entry checks.
- Audit trail.
- Data output formatting.
4. Validation.
- Fill-in-the-blank validation templates.
- Step-by-step validation.
5. Using the validated application.
- Maintaining, upgrading, re-validation.
6. Examples.
- Requirements.
- Specifications.
- Test cases.
7. How to turn on the audit trail.
- How to view the audit trail.
- All Excel users.
- IT.
- QA.
- QC.
- Laboratory staff.
- Managers.
- Executives.
- Auditors.
- GMP, GCP, GLP, regulatory professionals.
