Computer System Validation (CSV) Lifecycle
FDA 21 CFR Part 11 | GAMP 5 | EU Annex 11 | ALCOA+ Compliant
Planning
Requirements
Design
Build/Config
Testing (IQ/OQ/PQ)
Deployment
Maintenance
1
Planning
Project Initiation
Validation Master Plan (VMP)
- Scope & objectives
- Validation strategy
- Roles & responsibilities
- Timeline & milestones
Risk Assessment RISK
- Initial risk identification
- Impact assessment
- GAMP category (1-5)
- Validation approach
Validation Plan (VP)
- System description
- Test strategy
- Acceptance criteria
- Regulatory requirements
Data Integrity Assessment (Pre-Validation)
- Data flow mapping
- Risk identification (data integrity)
- Gap analysis (Annex 11/Part 11)
- Remediation planning
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2
Requirements
URS Development
User Requirements (URS) ALCOA+
- Functional requirements
- Data integrity controls (ALCOA+)
- Annex 11 & 21 CFR Part 11 compliance
- Audit trail requirements
- Electronic signatures & records
- Access control & security
- Data retention & retrieval
- Data life cycle requirements
Supplier Assessment
- Vendor audit
- Quality agreements
- Change control process
- Support & maintenance
Traceability Matrix
- URS to FS mapping
- FS to DS mapping
- Test coverage matrix
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3
Design
FS & DS
Functional Specification (FS)
- System functionality
- User interfaces
- Security controls
- Electronic signatures
Design Specification (DS)
- Technical architecture
- Database design
- Interface specifications
- Network topology
Design Review
- Compliance verification
- Risk review
- Design approval
Data Life Cycle Map
- Data creation & capture
- Data processing & use
- Data storage & retention
- Data retrieval & reporting
- Data archival & deletion
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4
Build/Config
System Development
System Configuration
- Software installation
- Parameter settings
- User access controls
- Security configuration
Configuration Specs (CS)
- As-built documentation
- Configuration baseline
- Version control
- Change tracking
Test Protocols
- IQ protocol
- OQ protocol
- PQ protocol
- Test scripts
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5
Testing
IQ / OQ / PQ
Installation Qualification (IQ)
- Hardware verification
- Software installation
- Environment checks
- Documentation review
Operational Qualification (OQ)
- Functional testing
- Security testing
- Audit trail verification
- Interface testing
Performance Qualification (PQ)
- End-to-end testing
- Business process validation
- Data integrity testing
- User acceptance testing
Test Summary Report
- Test results summary
- Deviation analysis
- CAPA tracking
- Compliance statement
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6
Deployment
Go-Live
Validation Summary Report
- Complete validation status
- Deviations & resolutions
- Compliance confirmation
- System release approval
Training & SOPs
- User training materials
- Standard operating procedures
- Training records
- Training effectiveness
System Release
- Production deployment
- Data migration
- Go-live support
- Release documentation
Data Integrity Assessment (Post-Validation)
- Verification of DI controls
- Annex 11/Part 11 compliance check
- Final risk review
- Remediation actions closure
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7
Maintenance
Operational Phase
Change Control
- Change requests
- Impact assessment
- Re-validation requirements
- Approval workflow
Periodic Review
- Annual product review
- System performance
- Incident trending
- Compliance status
Continuous Monitoring ALCOA+
- Audit trail review
- Security monitoring
- Data integrity checks
- Backup verification
Decommissioning
- Data archival
- Data retention
- System retirement
- Final documentation