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컴퓨터시스템 밸리데이션 기술
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Computerized System Validation Test Service

바이오써포트는 2002년도에 컴퓨터시스템 밸리데이션 컨설팅 및 기술 시험, 분석 서비스를 시작하여 다음과 같이 CGMP & 21 CFR Part 11, PIC/S GMP가이드라인, EU GMP Annex 11가이드라인 등에 따라 위험경감(Risk Reduction)을 기반으로 한 컴퓨터시스템 밸리데이션을 실행(시험 및 문서화)하고 컨설팅을 하고 있습니다.

표



Computerized System Validation (Test, analysis & Documentation)
  • ERP (Enterprise Resource Planning System)
  • MRP (Material Resource Planning System)
  • BMS (Building Management System)
  • EMS (Environmental Monitoring System)
  • MES (Manufacturing Execution System)
  • AWS (Automated Weighing System)
  • WMS (Warehouse Management System)
  • LIMS (Laboratory Information Management System)
  • Building, Facility, Utility Control Systems
  • Manufacturing Process Control Systems
  • IT Infrastructure
  • Clinical Trial and Data Management Systems

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Computerized System Development
  • The Development and Engineering of BMS(Building Management System) for GMP Facility

Computerized System Validation Test, analysis Service
  • System Development Management Supporting
  • Development of CSV Master Plan
  • Computerized System Design Supporting
  • 21 CFR Part 11 Assessment & Prioritization
  • URS, FS, DS Development
  • 21 CFR Part 11 Compliance Protocol, Test and Report
  • DQ, FAT, SAT, IQ, OQ and PQ Protocol, Execution and Report
  • System Retirement
  • Deviation Resolution
  • Retrospective Validation
  • Revalidation

표



Regulation Compliance Consulting
  • System & Process Gap Analysis
  • Computerized System Audit Service
  • Electronic Document Mangement
  • Electronic Records Retention
  • Personnel Training
  • SOPs Development and Review

CSV Management Consulting
  • CSV Project Management Master Plan
  • Risk Assessment
  • BCCP (Business Contingency & Continuity Plan)
  • IT Infrastructure Development(with our partner)




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