Documentation
Validation Standard
   ¡ò GAMP/CGMP/BPE2002/MCA/ISPE BASELINE GUIDES/FDA/EN46002
   ¡ò ISO 9000:2000/21 CFR PART11/WHO-GMP/cGMP.
Documentation system
   ¡ò URS: User Requirement Specification
   ¡ò DS: Design specification
   ¡ò VMP: Validation master plan
   ¡ò SOP: Standard Operational Procedure
   ¡ò ETOP:Enhanced Turn-Over Package
   ¡ò DQ: Design Quaiification
   ¡ò RA: Risk Analysis
   ¡ò IQ:Installation Qualification
   ¡ò OQ:Operationl Qualification
   ¡ò PQ: Performance Qualification
   ¡ò SQ: Software Qualification
   ¡ò PM: Preventive Maintenance procedure
   ¡ò FR: Final Report
   ¡ò CL: Cleaning Procedure
   ¡ò OP: Operation Procedure
   ¡ò CAL: Calibration Procedure
   ¡ò PV: Process Validation
   ¡ò CLV: Cleaning Validation
   ¡ò CV: Computer Validation
   ¡ò VR: Validation Report
   ¡ò Rev: Revalidation