Computer System Validation (CSV)

NA-SA Informatics can support your teams in managing your project, and provides consultancy on workflow analysis, STARLIMS solutions and hardware evaluation (kick-off, hardware acceptance, workflow analysis, Super User training, installation visit, dictionary preparation, project control, installation, test plan, acceptance milestones, go live).

  • User Requirement Specification (URS) Document
  • Functional Requirement Specification (FRS) Documentation
  • Functional Risk Assessment Document
  • Prepare Validation Plan and Validation Final Report
  • 21 CFR Part 11 Assessments
  • IQ and OQ Protocol and Summary
  • IQ, OQ, PQ Execution
  • Requirements Traceability Matrix
  • Validation Summary Report
  • System Release Certificate
  • Assist for User Acceptance Testing and Factory Acceptance Testing
  • Defect / Deviation Reports
  • Business SOPs
  • IT SOPs