Spreadsheet Development and Validation

Mitigating Risk of Errors in Business-Critical Calculations

Spreadsheets built for capturing complaints, reconciling clinical data, reporting safety signals and other processes can easily hide errors that undermine compliance. Our team brings rigor to quality-critical spreadsheet qualification.

 By establishing test cases that confirm full requirements traceability, logically accurate calculations, input/output controls, data integrity protections and more, our protocols verify:

  • – Formulas are completely free of hidden errors  
  • – Code changes require authorized review 
  • – Password controls restrict access
  • – Change control tracks modifications  
  • – Data flows don’t allow tampering
  • – Backup systems retain multiple generations

“A simple spreadsheet mistake by an employee was caught during Valitech’s rigorous testing – saving us from a very costly clinical trial disruption.”

 VP Quality, Aurum Clinical Research

Our spreadsheet qualification deliverables include:

  • – Intended Use Definition
  • – Requirements Specifications
  • – Design Blueprint 
  • – Code Review Checklists
  • – User Acceptance Testing 
  • – Traceability Matrices
  • – Validation Summary Report

With full documentation qualifying business calculations, make strategic decisions with confidence knowing models uphold the highest compliance standards.