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, Data Integrity 가이드라인 등에 따라 위험경감(Risk Reduction)을 기반으로 한 컴퓨터시스템 밸리데이션을 실행(시험 및 문서화)하고 컨설팅을 하고 있습니다.

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)
• D-QMS(Digital Quality Management System)
• EDMS(Electronic Document Management System)
• Building, Facility, Utility System Control Systems
• Manufacturing Process Control Systems
• IT Infrastructure
• Clinical Trial and Data Management Systems

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
• Data Integrity Compliance Protocol, Test and Report
• DQ, FAT, SAT, IQ, OQ and PQ Protocol, Execution and Report
• System Retirement
• Deviation Resolution
• Retrospective Validation
• Revalidation Protocol, Execution and Report

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)