Excel Spreadsheets; Develop and Validate for 21 CFR Part 11 Compliance

Spreadsheets are everywhere in GxP work, and poorly controlled ones lead to FDA 483s. This interactive 75-minute webinar shows how to develop and validate Excel spreadsheets for 21 CFR Part 11 compliance, step by step.

You'll follow along as Excel is configured for audit trails, security, versioning, cell protection, data entry checks, output formatting and multiple concurrent users, using Excel's built-in Part 11 features rather than macros. Bring your laptop and work on your own spreadsheets.

The session then covers validation with fill-in-the-blank templates and minimal documentation, what does and doesn't need validating, and how to maintain, upgrade and revalidate the application.

• Develop GxP-compliant spreadsheet applications in Excel
• Use Excel's built-in 21 CFR Part 11 features without programming macros
• Configure audit trails, security, data verification and cell and file protection
• Specify and test a spreadsheet application
• Validate the application with minimal documentation
• Decide what does and does not need to be validated

1. Why spreadsheets are so popular

• Spreadsheet overview
• What spreadsheets are used for

2. Why compliance is a problem

• How a spreadsheet differs from a calculator

3. Developing Part 11 applications

• Security
• Versioning
• Cell and file protection
• Data entry checks
• Audit trail
• Data output formatting
• Multiple concurrent users

4. Validation

• Fill-in-the-blank validation templates
• Step-by-step validation
• What does and does not need to be validated

5. Using the validated application

• Maintaining, upgrading and revalidating

6. Examples

• Requirements
• Specifications
• Test cases

7. Audit trail in practice

• How to turn on the audit trail
• How to view the audit trail

Spreadsheets are hard to keep compliant, and gaps can lead to 483s and Warning Letters. This session shows how to build GxP-compliant spreadsheet applications, raise compliance while using fewer resources, and cut validation time and cost.

It suits all Excel users, IT, QA, QC, laboratory staff, managers, executives, auditors, and GMP, GCP, GLP and regulatory professionals.

• All Excel users.
• IT.
• QA.
• QC.
• Laboratory staff.
• Managers.
• Executives.
• Auditors.
• GMP, GCP, GLP, regulatory professionals.

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.