OUR SERVICES

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