How to build and validate Excel spreadsheets for GxP compliance
This two-day seminar teaches how to develop and validate Excel spreadsheets for 21 CFR Part 11 compliance. This training event covers all of the required features that have to be configured in Excel. In class you will create the validation documents for an application that you develop. We will use the risk based computer system validation approach that typically saves two thirds of the validation time and costs. This event will make you a better Excel user and help you avoid FDA 483s. The validation approach can be applied to all types of Excel applications and other Commercial Off-The-Shelf applications.
Note: Participants must bring their laptop computer in order to develop and validate an Excel application.
Develop spreadsheet applications that are GxP compliant.
Avoid 483s and warning letters.
What does and does not need to be validated.
Learn how to use Excel´s built in 21 CFR Part 11 features.
Apply features required for GxP environments without programming macros.
Validate your application with minimal documentation.
Understand how to use risk assessment to reduce testing and improve productivity.
Participate in the workshop as we configure Excel for audit trails, security features, data verification, and multiple concurrent users.
Learn how to specify and test your application.
DAY ONE (8:30 AM – 4:30 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Regulations for Electronic Records
Code of Federal Regulations
21 CFR Part 11 - Compliance for Electronic Records & Signatures
Ten-Step Process for Risk-Based Computer System Validation
Excel Application Workshop - part 1
Develop User Requirements validation document for your application
Develop Project Plan validation document for your application
Develop Functional Specifications validation document for your application
DAY TWO (8:30 AM – 4:30 PM)
How to Conduct a Hazard Analysis/Risk Assessment
Mitigations, impact on testing
Excel Application Workshop - part 2
Develop Hazard Analysis validation document for your application
Develop Testing Protocol validation document for your application
Main Concepts to Remember