Computerized System Validation ensures that any software or automated system used in GMP environments consistently performs as intended, maintains data integrity, and complies with regulatory expectations. PrimeGMP provides complete CSV services from system assessment to qualification, documentation, and lifecycle management.

1. System Assessment & GxP Impact

• Categorization of the system as per GAMP 5
• Identification of GxP-relevant functions
• Data integrity risk assessment (ALCOA+)
• Definition of system boundaries, workflows, and interfaces

2. Validation Planning & Documentation

We prepare full CSV documentation including:

• Validation Master Plan / Validation Plan
• User Requirement Specification (URS)
• Functional Specification (FS)
• Design Specification (DS)
• Risk Assessment (RA / FMEA)
• Traceability Matrix (TM)
• Data Mapping & Audit Trail Requirements
• Supplier Assessment / Vendor Audit (if applicable)

3. Installation Qualification (IQ)

• Verification of hardware & software installation
• System configuration documentation
• License verification & version control
• Backup & restore functionality
• Verification of prerequisites and environment (OS, SQL, network)
• Review of vendor installation guides & technical documentation

4. Operational Qualification (OQ)

• Functional testing of all GxP-relevant features
• Verification of workflows, permissions, and calculations
• Alarm, alert, deviation, and error-handling testing
• Audit trail testing (creation, modification, deletion events)
• Electronic signature verification
• Access control and user role-based security testing
• Data integrity & traceability testing
• Interface testing with connected systems (LIMS, ERP, SCADA, EMS)

5. Performance Qualification (PQ)

• Testing under actual operational conditions
• Process simulation with real or representative data
• Verification of routine workflows, batch records, and reports
• Stress/load testing (if applicable)
• End-to-end data lifecycle evaluation

6. Part 11 & Annex 11 Compliance Testing

• Electronic records & electronic signatures (ERES) verification
• Audit trail review functionality
• Access control, password policies, and session timeouts
• Data archival, retrieval, and retention
• Disaster recovery & business continuity checks
• Data backup and restore validation

7. Post-Implementation Support

• Change control management
• Periodic review of computerized systems
• Revalidation after upgrades/patches
• SOP development for:
  • System Operation
  • Backup & Restore
  • Audit Trail Review
  • User Management
  • Change Management
  • Incident & Deviation Handling

Systems We Validate

• LIMS
• EMS/BMS
• PLC/SCADA systems
• ERP modules (QA/QC/Production)
• Laboratory Instruments with software
• Chromatography Data Systems (CDS)
• Manufacturing Execution Systems (MES)
• Stability & Warehouse Monitoring Systems
• Weighing & Dispensing Software
• Quality Management Systems (eQMS)
• Document Management Systems (DMS)

Regulatory Standards Followed

• GAMP 5 (Good Automated Manufacturing Practice)
• 21 CFR Part 11 (Electronic Records & Signatures)
• EU Annex 11 (Computerized Systems)
• ISO 27001 (Information Security)
• WHO TRS 1019
• Data Integrity ALCOA+ Principles

Why Choose PrimeGMP for CSV?

• Deep experience with regulated computerized systems
• Strong data integrity and Part 11 expertise
• End-to-end documentation & execution support
• Audit-ready validation reports
• Ability to validate simple instruments to complex automated platforms
• Practical, risk-based approach compliant with global standards