Validation Master Plan

 Impact & Risk Assessment

URS

 Computerized Compliance Assessment

Computerized System List

Qualification Protocols (IQ/OQ/PQ)

 Computerized Infrastructure Qualification

Procedue Schedule

21 CFR Part 11 & EU Annex 11

 Suppliers Auditing & Selection

 Computerized Project Management

Main introduction to computer system：

ERP

Enterprise Content Management (Documentum, FCG First Docs…)
Process Control Systems (PLC/SCADA/BMS/DCS)
LIMS, Laboratory Equipment, Empower, Open Lab, ECM, LC-solution
QMS Systems / CAPA System
EBRS (Electronic Batch Record Management System)
Training Systems
Warehouse Management Systems
Pharmacovigilance
Statistical Process Control (SPC)
Process Analytical Technology (PAT)
Maintenance System (Maximo)
Calibration Management Systems