Spreadsheet Validation based on GAMP 5
Spreadsheet Validation MS Excel 365 based on GAMP 5, excel spreadsheet validation
Lectures -8
Resources -1
Duration -47 mins
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Course 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.
Scope of the course:
- Introduction
- Spreadsheet classification & categorization
- Spreadsheet validation based on categories
- Specific spreadsheet requirements
- Spreadsheet development – good practices
- Qualification protocol specifics for spreadsheets
- Operational & retirement specifics for spreadsheets
Spreadsheet 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.
Goals
The goal of the course:
- Explore specific aspects of MS Excel spreadsheet validation
- Find out how to categorize MS Excel spreadsheets
- Learn how to validate spreadsheets based on categories 5 and 4
- Learn about specific requirements and test cases related to spreadsheet validation
- Find out good spreadsheet design practices
Prerequisites
None
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Curriculum
Check out the detailed breakdown of what’s inside the course
Introduction
2 Lectures
-
Introduction 01:27 01:27
-
Spreadsheet classification & categorization 05:06 05:06
Spreadsheet validation and design
6 Lectures
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Instructor Details
Adrian Krzesniak
I am a seasoned Computer System Validation expert with over 15 years of extensive experience. My professional background encompasses a wide range of disciplines, including Information Technology, Software Development, Quality Assurance, and Software Quality Assurance. Throughout my career, I have had the privilege of imparting knowledge to and training hundreds of individuals in various facets of Computer System Validation.
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