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Spreadsheet Validation based on GAMP5
Published 11/2023
Created by Adrian Krzesniak
MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz, 2 Ch
Genre: eLearning | Language: English | Duration: 8 Lectures ( 47m ) | Size: 251 MB
Spreadsheet Validation MS Excel 365 based on GAMP5
Published 11/2023
Created by Adrian Krzesniak
MP4 | Video: h264, 1280x720 | Audio: AAC, 44.1 KHz, 2 Ch
Genre: eLearning | Language: English | Duration: 8 Lectures ( 47m ) | Size: 251 MB
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.
Who this course is for
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.
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