Spreadsheet Validation based on GAMP 5

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 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

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.