Computer Software
Validation
Validation of computer systems is essential to confirm accuracy, reliability, and consistent performance — and to detect invalid or modified records. Our CSV specialists ensure complete compliance with electronic record standards.
21 CFR Part 11
GAMP 5 Compliant
Risk-Based Approach
Validation Flow
Real-time process
Requirements
Risk Assessment
Testing
Documentation
04
IQ
OQ
PQ
Best practices,
regulator-
ready.
Comprehensive computer system validation services following industry best practices and regulatory guidelines.
Computer System Validation (CSV)
End-to-end CSV for GxP-impacting systems with risk-based rigor, full traceability, and inspection-ready documentation.
Legacy System Upgradation
Validated migration, retrofit, and upgrade strategies that protect data integrity while modernizing aging systems.
PLC and SCADA Validation
Functional, integration and performance validation of automation systems controlling critical pharma processes.
A systematic six-
step
approach.
Comprehensive validation with clear deliverables and complete audit trails at every stage.
Requirements Gathering
Key Deliverables
- Requirements Documentation
- System Impact Assessment
- User Requirements Specification
Risk Assessment
Key Deliverables
- Risk Assessment Reports
- Risk Mitigation Strategies
- Critical Control Point Analysis
Validation Planning
Key Deliverables
- Validation Master Plan
- Test Case Documentation
- Acceptance Criteria Definition
Testing & Documentation
Key Deliverables
- Test Execution Records
- Performance Test Results
- User Acceptance Test Reports
Ongoing Maintenance
Key Deliverables
- Change Control Procedures
- Periodic Review Reports
- Re-validation Protocols
Coverage across every layer.
Comprehensive validation services for all types of computerized systems in pharmaceutical operations.