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