Spreadsheet Validation Based On Gamp5

Spreadsheet Validation MS Excel 365 based on GAMP5

What you'll learn

computer system validation specialist

software quality assurance

software tester

computer system validation consultant

software developer for GxP

GxP specialist

MS excel specialist

Requirements

Basic knowledge related to computer system validation is gained through the training based on GAMP 5, edition 2.

Description

Validation of Excel Spreadsheets: Spreadsheets are specialized computerized systems utilized in GxP to store and calculate data. Validating such systems involves specific considerations related to design, requirements, risk, and test cases.The goal of the course:Explore specific aspects of MS Excel spreadsheet validationFind out how to categorize MS Excel spreadsheetsLearn how to validate spreadsheets based on categories 5 and 4Learn about specific requirements and test cases related to spreadsheet validationFind out good spreadsheet design practicesScope of the course:IntroductionSpreadsheet classification & categorizationSpreadsheet validation based on categoriesSpecific spreadsheet requirementsSpreadsheet development – good practicesQualification protocol specifics for spreadsheetsOperational & retirement specifics for spreadsheetsSpreadsheet validation, as per GAMP 5 guidelines, is crucial to ensure the integrity and reliability of data in regulated environments. GAMP 5, the Good Automated Manufacturing Practice guide, provides a comprehensive framework for validating computerized systems, including spreadsheets. The validation process involves risk assessment, where criticality and complexity determine the extent of validation activities.Validating spreadsheets includes verifying formulae, data integrity, and user access controls. GAMP 5 also stresses the need for maintaining comprehensive documentation throughout the validation lifecycle. Adhering to these guidelines ensures that spreadsheet-based systems meet regulatory requirements, reducing the risk of errors and inaccuracies in critical data, and ultimately supporting data integrity in regulated industries.

Overview

Section 1: Introduction

Lecture 1 Introduction

Lecture 2 Spreadsheet classification & categorization

Section 2: Spreadsheet validation and design

Lecture 3 Specific Spreadsheet Requirements

Lecture 4 Spreadsheet Category-based validation

Lecture 5 Spreadsheet Development

Lecture 6 Practical example

Lecture 7 Qualification Protocol Specifics for Spreadsheets

Lecture 8 Operational & Retirement Specifics for Spreadsheets

This course is designed for computer system validation specialists who want to enhance their knowledge in the validation of specific computerized systems, such as Excel spreadsheets.