Excel Spreadsheet in FDA Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance

Overview:

Join us for an interactive webinar that demystifies the process of configuring and validating GxP compliant spreadsheet applications to prevent FDA 483s and enhance your Excel proficiency. In this hands-on session, we will guide you step by step through configuring Excel for audit trails, security features, data entry verification, and more. Learn how to validate your application with minimal documentation and adapt Excel to suit your unique needs.

This comprehensive webinar is designed to help you develop GxP compliant spreadsheet applications using Excel's built-in 21 CFR Part 11 features, without the need for programming macros. You will also discover practical techniques to avoid 483s and Warning Letters, streamline validation time and costs, and increase compliance while reducing resource requirements.

Areas covered during the session include:

• Developing GxP compliant spreadsheet applications
• Utilizing Excel's built-in 21 CFR Part 11 features
• Apply features required for GxP environments without programming macros.
• Configuring Excel for audit trails, security features, data verification, and multiple concurrent users
• Avoid 483s and Warning Letters
• Implementing cell and file protections
• Understanding the validation scope and minimizing documentation
• Understand what does and does not need to be validated.
• Specifying and testing your application
• Q&A

Learning Objectives:

Why are spreadsheets so popular?

• Spreadsheet overview
• What are they used for?

Why is compliance a problem?

•  How is it different from a calculator?

Developing Part 11 applications

• Security
• Versioning
• Cell protection
• Data entry checks
• Audit trail
• Data output formatting

Validation 

• Fill-in-the-blank validation templates
• Step-by-step validation

Using the validated application

• Maintaining, upgrading, re-validation

Examples

• Requirements
• Specifications
• Test cases

How to turn on the audit trail

• How to view the audit trail

Why should you attend?

Join our interactive, expert-led webinar to master the art of configuring and validating GxP compliant spreadsheet applications in Excel, minimizing the risk of FDA 483s. This hands-on session will not only enhance your Excel proficiency but also help you save time and reduce costs associated with spreadsheet validation and compliance.

Discover how to leverage Excel's built-in 21 CFR Part 11 features for GxP compliance without programming macros. Learn practical techniques for implementing audit trails, security features, data entry verification, and cell protection. Understand the scope of validation and how to minimize required documentation, streamlining the process and reducing resource needs.

Don't miss this valuable opportunity to sharpen your Excel skills, boost your confidence in GxP compliant spreadsheet applications, and stay ahead in the rapidly evolving landscape of computer system validation.

Who will benefit?

• Excel users in FDA Regulated Environment
• Quality Assurance Managers and Specialists
• Validation Engineers and Managers
• Regulatory Affairs Professionals
• IT Professionals -  IT professionals working in the life sciences industry need to understand how to configure and validate GxP compliant spreadsheet applications to ensure that the systems they support are in compliance with FDA regulations.
• Data Analysts and Managers
• Clinical Research Managers and Associates
• Laboratory Managers and Scientists