Summary of the Workshop:
In this two-day seminar you will learn how to configure Excel applications with the features required for 21 CFR Part 11 thereby helping you to avoid 483s. Using the risk based computer system validation approach you will validate your own Excel application. Use of the validation templates typically saves two thirds of the validation time and costs. This seminar will improve your Excel skills and create a set of validation documents that you can use for subsequent Excel application and other Commercial Off-The-Shelf (COTS) validation projects.
Participants must bring their laptop and an Excel application to validate. To get full benefit of this workshop it is best to come with a colleague so you can be your own project team.
Introduction to the Excel Spreadsheet
Learn Regulations for Electronic Records
Learn 21 CFR Part 11 - Electronic Records & Signatures
Ten Step Process for Risk-Based Computer System Validation
Learn Excel Applications and how to create a User Requirements, Project Plan and Functional Specifications
How to Conduct a Hazard Analysis/Risk Assessment
Excel Applications and how to create Hazard Analysis and Testing Protocol document for your application