Excel Spreadsheets; Ensuring Data Integrity and 21 CFR Part 11 Compliance
Instructor:
David Nettleton
Product ID: 701582
- 21
- January 2025
Tuesday - 10:00 AM PT | 01:00 PM ET
Duration: 75 min
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.
Who Will Benefit:
This session will benefit for:
- Computer system users
- IT personnel
- QA personnel
- Managers
- Executives
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.
Frequently Asked Questions:
- Would you suggest executing a trace matrix to the user specs or to the user requirements?
- During the CSV documents, you mentioned Functional Specs. Does it make sense to include Design docs on the validation?
- Do we require to verify manual calculation versus with excel calculation
- If my protection box is grayed out in excel, is that a software issue? "List changes on a new sheet" in the Highlight Changes (when you select Track Changes (legacy))
- Does audit trail only turn on when file is saved?
- I have 365. How do you find the audit trail there?
- Can you expand on how much data is too much data to store in Excel? I know you mentioned not using it as a database.
- I know you mentioned doing double data entry, can you expand on how to build this?
- Should we only protect the file once it is fully ready and built so that you don't have to continually turn on and off all of those settings?
- How do we create a password for the file in Windows (it seems to be different from the way you are showing)
- Can you show what it will look like for the user to save the file as read only file.
More Training By Experts
- GAMP® Validation Protocols for Efficient Documentation
- 10-Step Risk Based Computer System Validation for SaaS/Cloud/Local Hosting
- Use Risk Assessment to Reduce Validation Time for 21 CFR Part 11
- Data Integrity and Privacy: Compliance with 21 CFR Part 11, SaaS/Cloud, EU GDPR
- How to Buy COTS Software, and Audit and Validate Vendors
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
