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.
1. Why are spreadsheets so popular?
2. Why is compliance a problem?
3. Developing Part 11 applications.
4. Validation.
5. Using the validated application.
6. Examples.
7. How to turn on the audit trail.
1. Why are spreadsheets so popular?
2. Why is compliance a problem?
3. Developing Part 11 applications.
4. Validation.
5. Using the validated application.
6. Examples.
7. How to turn on the audit trail.
David Nettleton
Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, EU GDPR 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 300 mission-critical laboratory, clinical, and manufacturing software implementation projects. His most recent book is Software as a Service (SaaS) Risk-Based Validation With Time-Saving Templates, which provides fill-in-the-blank templates for completing a COTS software validation project.
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