Validation System Organigram

Complete Validation System Organigram

Complete Validation System Organigram

FDA Guidelines • ISO Standards • CFR Regulations • GMP Compliance

Phase 1: Validation Planning & Strategy
Foundation and regulatory alignment
Validation Master Plan (VMP)
  • Regulatory requirements analysis
  • Validation scope definition
  • Resource allocation
  • Timeline establishment
  • Risk assessment framework
System Assessment
  • GxP impact assessment
  • System categorization
  • Critical function identification
  • Data integrity requirements
  • Computerized system validation
Quality Management
  • Quality system alignment
  • Document control procedures
  • Change control processes
  • Training programs
  • Audit trail requirements
21 CFR Part 11 ICH Q7 ISO 9001 GAMP 5
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Phase 2: User Requirements Specification (URS) & Risk Assessment
Requirements definition and risk evaluation
URS Development
  • Functional requirements
  • Performance specifications
  • Interface requirements
  • Security requirements
  • Regulatory compliance needs
Risk Assessment
  • Failure Mode Effects Analysis (FMEA)
  • Hazard Analysis (HAZOP)
  • Risk prioritization matrix
  • Control measures identification
  • Risk acceptance criteria
Traceability Matrix
  • Requirements traceability
  • Test coverage mapping
  • Verification matrix
  • Validation coverage
  • Gap analysis
ICH Q9 (QRM) ISO 14971 FDA QSR 21 CFR 820
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Phase 3: Installation Qualification (IQ)
System installation verification
Installation Documentation
  • Equipment delivery verification
  • Installation procedures
  • Environmental conditions
  • Utility connections
  • Safety system checks
System Configuration
  • Hardware configuration
  • Software installation
  • Network connectivity
  • Security settings
  • Backup systems
Documentation Review
  • Vendor documentation
  • Installation certificates
  • Calibration certificates
  • Material certificates
  • As-built drawings
21 CFR 211 ISO 15378 GMP Annex 15 ISPE GAMP
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Phase 4: Operational Qualification (OQ)
System functionality verification
Functional Testing
  • Operating range verification
  • Alarm and safety systems
  • Control system functionality
  • Interface testing
  • Data integrity verification
Calibration & Testing
  • Instrument calibration
  • Accuracy verification
  • Precision testing
  • Repeatability studies
  • Linearity assessment
System Integration
  • Integration testing
  • Communication protocols
  • Data transfer verification
  • Backup and recovery
  • Error handling
USP <1058> ISO 17025 21 CFR 211.68 ICH Q2(R1)
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Phase 5: Performance Qualification (PQ)
Process performance demonstration
Process Validation
  • Consecutive successful batches
  • Process capability studies
  • Statistical analysis
  • Worst-case scenarios
  • Process robustness
Product Quality
  • Product specification testing
  • Quality attribute verification
  • Stability testing
  • Bioavailability/Bioequivalence
  • Shelf-life validation
Documentation
  • Batch records review
  • Analytical data evaluation
  • Statistical reports
  • Deviation investigations
  • Final validation report
ICH Q8/Q9/Q10 FDA Process Validation 21 CFR 211.110 GMP Annex 15
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Phase 6: System Release & Documentation
Final approval and documentation completion
Validation Report
  • Executive summary
  • Test results compilation
  • Deviation analysis
  • Conclusion and recommendations
  • Approval signatures
System Release
  • Management review
  • Quality assurance approval
  • Regulatory compliance confirmation
  • Commercial release authorization
  • Training completion verification
Handover Package
  • SOPs and work instructions
  • Maintenance procedures
  • Troubleshooting guides
  • Training materials
  • Change control procedures
ICH Q7 21 CFR 211.180 ISO 13485 GMP Chapter 4
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Phase 7: Ongoing Compliance & Lifecycle Management
Continuous monitoring and maintenance
Continued Process Verification
  • Ongoing monitoring
  • Trend analysis
  • Statistical process control
  • Performance indicators
  • Annual product reviews
Change Management
  • Change impact assessment
  • Revalidation requirements
  • Documentation updates
  • Risk reassessment
  • Approval workflows
Periodic Review
  • Validation status assessment
  • Regulatory update review
  • Performance trending
  • System health checks
  • Revalidation planning
ICH Q12 21 CFR 211.22 GMP Chapter 1 ISO 9001 CAPA
Regulatory Compliance Matrix

FDA CFR Title 21

Parts 11, 210, 211, 820, 1271

ICH Guidelines

Q2, Q7, Q8, Q9, Q10, Q12

ISO Standards

9001, 13485, 14971, 15378, 17025

EU GMP

Annex 11, 15, 16, Chapter 1, 4

ISPE GAMP

GAMP 5, Good Practice Guides

USP Chapters

<1058>, <1226>, General Chapters