VALIDATION SERVICES
Full portfolio of validation services implemented as individual activities or turn-key services
Project Management and Delivery
- Project Planning
- Cost-Benefit Analysis
- Change Management
- Validation Strategy
- Subject Matter Expertise
Services tailored to meet the needs for big or small, well defined or development needs
Technical Support
- UAT Testing
- Protocol Execution
- Report Generation
- Documentation Support
Development and Support of Computer System Validation Deliverables
- Validation Master Plan (VMP)
- System risk assessment report
- User requirements specification
- System configuration specification
- System Application Form (SAF)
- Part 11 Gap Assessment Form (GAF)
- System Assessment Checklist (SAC)
- Effectiveness Check Form and Report (ECR)
- Change Control Request for Remediation or Validation (CCR)
- Validation Test plan
- Validation Protocols – IQ, OQ, PQ
- Requirements Traceability Matrix (RTM)
- Quality assurance review
- Validation summary report
- Standard Operating Procedures (SOPs)
- Others