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)