At FicusRealtime, we offer comprehensive Excel Sheet Validation services tailored for GxP-regulated industries. Our approach ensures that your spreadsheets used in critical operations are secure, accurate, and compliant with global standards like 21 CFR Part 11, EU Annex 11, and GAMP 5.
Our Validation Approach
Requirement Gathering:
Define user needs and intended use (URS – User Requirement Specification).
Spreadsheet Design Review:
Evaluate structure, formulas, macros, input fields, and protection settings.
Risk Assessment:
Analyze potential risks based on data criticality and regulatory impact.
Test Script Development:
Create validation test cases to verify formulas, logic, and boundary conditions.
Execution & Documentation:
Perform and document tests with screenshots, results, and deviation logs.
Security & Control Setup:
Implement protection mechanisms, restricted access, and version control.
Validation Summary Report (VSR):
Deliver a complete report with validation outcome and final approval.