Excel Spreadsheets- How to Ensure 21 CFR Part 11 Compliance

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Presentation Description

Learn to create a GxP compliant Excel spreadsheet application. Understand how to validate Excel spreadsheets with minimal documentation. Learn to configure Excel for audit trails, security features, and data entry verification.

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Presentation Transcript

Excel Spreadsheets -How to Ensure 21 CFR Part 11 Compliance? :

Excel Spreadsheets -How to Ensure 21 CFR Part 11 Compliance?

What are Spread-sheets?:

What are Spread-sheets ?

FDA Expectations for Use of Spreadsheets :

FDA Expectations for Use of Spreadsheets

21 CFR Part 11 Requirements:

21 CFR Part 11 Requirements

Which Spreadsheets should be Compliant? :

Which Spreadsheets should be Compliant?

Best Practices to Comply with FDA Requirements:

Best Practices to Comply with FDA Requirements

Slide7:

Want to learn more about 21 CFR Part 11, its requirements and best practices to comply with them? ComplianceOnline webinars and seminars are a great training resource. Check out the following links: Excel Spreadsheets: Develop and Validate for 21 CFR Part 11 Compliance Design and Validation of Excel Spreadsheets: Step-by-Step Learning from Recent FDA Warning Letters Related to Part 11 Understanding and Implementing FDA'S 21 CFR Part 11 How to Comply with 21 CFR Part 11 Requirements for Electronic Medical Records Computerized System Validation - A Detailed Insight 21 CFR Part 11: How to Successfully Prepare for and Host an FDA Inspection Complying with 21CFR Part 11-Understanding the Role of Predicate Rules

Slide8:

Thank You To k now more on 21 CFR 11compliance visit www.complianceonline.com

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