Strategic Regulatory Consulting for Accelerated Global Compliance

Excel Sheet Validation

At FicusRealtime, we offer comprehensive Excel Sheet Validation services designed to meet the regulatory expectations of GxP-compliant industries. Excel spreadsheets used for calculations, records, or decision-making must be validated to ensure they perform accurately, reliably, and securely—especially when used in regulated environments.

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.

 

Industries We Serve

Industry-Specific Software for Enhanced Quality and Compliance

Pharma
Advancing healthcare through pharmaceutical innovations.
Engineering
Precision engineering solutions for industrial applications.
Excipients
Quality excipients for enhanced pharmaceutical formulations.
Formulations
Innovative drug formulations for effective treatments.
Biologicals
Advanced biological solutions for medical and research use.
Biotechnologicals
Cutting-edge biotechnological applications for various industries.
CRO/CDMO
Contract research and manufacturing for pharma industries.
Aquatic/Poultry
Innovative healthcare solutions for aquaculture and poultry.
Agro Based
Sustainable agro-based solutions for farming industries.
Biotherapeutics
Targeted therapies for enhanced healthcare solutions.
Aquatic Medical Devices
Medical advancements for aquatic life healthcare.
Cosmetics
Beauty and skincare innovations for enhanced personal care.
Polymers
Advanced polymer solutions for diverse industries.
Agro Chemicals
Sustainable agro-chemical solutions for modern farming.
Special Chemicals
Innovative chemical solutions for industrial applications.
Drug Pellets
Revolutionary drug pellet formulations for improved delivery.
Nano Technology
Advanced nano-technology solutions for various sectors.

Testimonials

20K+ Satisfied Clients World Wide