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Data Integrity Guide: Spreadsheet Validation
Strengthen Spreadsheet Controls. Reduce Compliance Risk.
Spreadsheets remain one of the most widely used tools across pharmaceutical operations, supporting everything from laboratory calculations and stability programs to equipment maintenance, quality systems, and product release decisions. Yet improperly controlled spreadsheets continue to be cited in regulatory observations and data integrity findings.
Developed by the Rx-360 Data Integrity Working Group, the Data Integrity Guide: Spreadsheet Validation provides a practical, risk-based framework to help organizations evaluate, validate, maintain, and govern spreadsheets used in regulated environments.
What You’ll Learn
This guide helps quality, compliance, validation, laboratory, and manufacturing professionals:
- Assess spreadsheet risk – based on intended use and potential impact to product quality, patient safety, and regulatory compliance
- Establish appropriate validation requirements and documentation deliverables
- Implement controls for security, access management, data entry, version control, and change management
- Strengthen ongoing spreadsheet maintenance, periodic review, backup, and archival practices
- Understand common regulatory concerns and FDA inspection observations related to spreadsheet use
- Apply industry best practices to support data integrity and inspection readiness
Inside the Guide
The guide covers:
- Risk Level Assessment
- Spreadsheet Validation Planning
- Requirements and Testing Approaches
- Security and Access Controls
- Operational Controls and Maintenance
- Change Management and Version Control
- Backup, Recovery, and Periodic Review
- Regulatory References and FDA 483 Observation Examples
Who Should Download This Guide?
This resource is ideal for:
- Quality Assurance and Quality Control professionals
- Validation and CSV teams
- Data Integrity leaders
- Laboratory managers and analysts
- Manufacturing and Operations personnel
- Regulatory Affairs professionals
- Anyone responsible for spreadsheets that support GxP activities
Download the Guide
Learn how to apply a risk-based approach to spreadsheet validation, strengthen data integrity controls, and support regulatory compliance across your organization.
Complete the form to access the Rx-360 Data Integrity Guide: Spreadsheet Validation.