Computerized System Validatio
Our Advantages
- —— Much more experiences in main regulatory market
- —— Successful CSV cases in global market
- —— Retrospective validation strategy
- —— With CSV team to provide emergency service within a short time
Our Services：
- —— IT Compliance Assessment
- —— Validation Master Plan
- —— IT System List
- —— Impact & Risk Assessment
- —— Clinical and factory data integrity and authenticity assessment
- —— URS
- —— Qualification Protocols (IQ/OQ/PQ)
- —— IT Infrastructure Qualification
- —— IT Project Management
- —— Procedue Schedule
- —— Suppliers Auditing & Selection
- —— 21 CFR Part 11 & EU Annex 11
Main introduction to computer system：
- —— ERP & MRP (SAP, Oracle, JD Edwards….)
- —— 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 (Tracwise)
- —— EBRS (Electronic Batch Record Management System)
- —— Building Management Systems (Siemens Desigo)
- —— HR Training Systems
- —— Enterprise Asset Management Systems
- —— Warehouse Management Systems
- —— Pharmacovigilance
- —— Statistical Process Control (SPC)
- —— Process Analytical Technology (PAT)
- —— MES
- —— Maintenance System (Maximo)
- —— Calibration Management Systems
- —— eCTD (Common Technical Document)
