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)