컴퓨터 시스템 밸리데이션 (Computer System Validation - CSV) : Policy / IT / Automatic Control System

GxP Computer System Management

Management
  • - Computer System Compliance Pliicy
  • - ERES Pliicy
  • - CSV Pliicy
  • - CSVMP
  • - SDLC Standard
  • - CS Inventory
Development
  • - Create URS
  • - Vendor / Project Management
  • - Document Management
  • - Business Continuity Plan
  • - Disaster Recovery Plan
Operation
  • - System Operation
  • - System Maintenance / Administration
  • - Backup & Recovery / Archive & Retrieval
  • - Periodic Review
  • - Internal Audit
  • - Retirement
Supporting Process
  • - Change Control
  • - Configuration Management
  • - Training

GxP IT Computer System Validation

R&D / Clinical System
  • - Clinical Data Integration (CDI)
  • - Home Monitoring System
  • - Clinical Trial Management System (CTMS)
  • - eIRB System
  • - EDC / CDM System
Enterprise Resource Planning (ERP)
Master Data Management (MDM)
QC(품질관리)
  • - Laboratory Information Management System (LIMS)
  • - Environment Management System (EMS)
QA(품질보증)
  • - Quality Management System (QMS)
  • - Electronic Data Management System (EDMS)
  • - Learning Management System (LMS)
Production (생산)
  • - Manufacturing Execution System (MES)
Warehouse (창고)
  • - Automatic Warehouse Management System(AWMS)
  • - 2D Serialization & Aggregation (일련번호 시스템)

GxP Automatic Control System

Production(생산)
  • - Process Control System (PCS)
  • - SCADA System
  • - DCS
Utility (시설)
  • - Building Management System (BMS)
  • - Environment Management System(EMS)
  • - HVAC System
  • - Compressed Air System (CA)
  • - Purified Water System (PW)
GxP 컴퓨터 시스템 밸리데이션 (Computer System Validation - CSV) : 생산 / 분석 & 시험기기 / 지원설비

Production Equipment(생산장비)

  • 믹서기 / 타정기 / 선별기
  • 코팅기 / 충전기 / 포장기 / 계수기
  • 혼합기 / 카토너 / 라벨러 / 믹서기
  • 테핑기 / 세병기 / 과립기 / 부착기
  • 씰링기 / 비닐삽입기 / 세병기
  • Vision 검사기
  • 낱알식별 표시 인쇄기
  • Bioreactor(미생물 반응기)
  • Autoclave(가압처리기)
  • CO2 Incubator (수소 인큐베이터)
  • LN2 Tank(질소 탱크)
  • K401
  • UF Skid
  • Centrifuge(원심분리기)
  • Homogenizer(조직분쇄기)
  • Dry Oven(드라이오븐)
  • Deep freezer(냉동냉장고)
  • Filter Dryer
  • Fermentor(발효기)
  • Lyophilizer(동결건조기)
  • Sterilzer(멸균기)
  • Ultrafiltration(한외여과기)
  • etc

Analysis Instrument(분석 및 시험 설비)

  • ECM
  • Open Lab CDS Network System
  • 칼피셔 & Coulometer
  • 항온항습기
  • BOD인큐베이터
  • 표준품냉동고
  • 보관검체실 제어판
  • Nugenesis SDMS
  • LACE System
  • 초순수제조장치
  • 융점측정기
  • 점도계
  • LOD측정기
  • 탭밀도 측정기
  • 고온 건조기
  • 회화로
  • 원심분리기
  • Mass Spectrometer(질량측정기)
  • Endotocxin
  • FACS
  • 자외가시부 분광광도계
  • 원자흡광 광도계
  • Liquid particle counting
  • Flow Cytometry Analyzer
  • LC / GC
  • etc

Utility Facility ( 지원설비)

  • PW / WFI (정제수 시스템)
  • HVAC(공기조화 시스템)
  • Temperature Monitoring System(TMS)
  • RT-PCR
  • etc