COMPUTER SYSTEM VALIDATION (CSV)
COMPUTER SYSTEM VALIDATION (CSV)
Ensuring Your Digital Systems Meet FDA Standards
Ensuring Your Digital Systems Meet FDA Standards
Guaranteed 21 CFR Part 11 compliance for all your regulated computer systems
WHY CSV MATTERS?
SYSTEMS WE VALIDATE
- LIMS
- ERP / MES
- SCADA
- QMS Software
- Analytical Instruments
- Custom Applications
OUR CSV METHODOLOGY
- 1. Requirements Definitions
- 2. Risk Assessment
- 3. Protocol Development
- 4. Execution & Testing
- 5. Reporting & Maintenance
THE EUREKA CSV DIFFERENCE
GAMP5-Aligned & Risk-Based
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Category-Specific Strategies Right-sized validation for your system type
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Integrated with Process Validation Seamless coordination when both CSV and CQV are needed
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Future-Proof Documentation Easily maintained and updated for system changes
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Electronic Records Focus Full Part 11 compliance for data integrity