Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance

Why Should You Attend:

This course will train attendees on best practices to create a spreadsheet that is GxP compliant using Microsoft Excel. Attendees will understand how to validate applications with minimal documentation. The course will also offer step-by-step instructions to configure Excel for audit trails, security features, and data entry verification. This session will also include an interactive workshop for participants to learn important techniques for using Excel spreadsheets for GxP data.

Areas Covered in the Webinar:

• Avoid 483s and Warning Letters.
• Ensure compliance with 21 CFR Part 11 when using Excel spreadsheets for GxP data.
• How to use cell and file protections.
• How to use Excel’s audit trail.
• Reduce validation time and costs.
• Increase compliance while lowering resource needs.
• Understand what validation documentation is required.
• Hands-on workshop to address your specific needs.

Instructor Profile:

David Nettleton
FDA Compliance Specialist, ComputerSystemValidation

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 260 mission critical laboratory, clinical, and manufacturing software implementation projects. His most popular book is Risk Based Software Validation - Ten easy Steps, which provides fill-in-the-blank templates for completing a COTS software validation project.