- Speaker : David Nettleton
- Session Code : DNSEP1522
- Date : 15th September 2022
- Time : This Event is Over
- Duration : 90 Mins
Excel Spreadsheets in FDA Environment - Ensuring Data Integrity and 21 CFR Part 11 Compliance
Overview:
This interactive webinar explains how to configure and validate a 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.
Areas covered during the session:
- 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:
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
Who will benefit?
- Excel users in FDA Regulated Environment
- IT
- QA
- QC
- Laboratory staff
- Managers
- Executives
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 General Data Protection Regulation (GDPR), software validation, and computer system validation.
Mr. Nettleton 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.
Mr. Nettleton 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.