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SOFTWARE VALIDATION
21 CFR PART 11
21 CFR PART 820 QSR
COMPLIANCE SOFTWARE
SOFTWARE VALIDATION DOCUMENTATION
GOOD COMPUTER SYSTEM VALIDATION
SCADA/PLC/HARDWARE VALIDATION
RISK ASSESSMENT
PROCESS VALIDATION
GVP - GOOD VALIDATION PRACTICE
METHOD & ANALYTICAL VALIDATION
CLEANING VALIDATION
ANALYTICAL EQUIPMENT VALIDATION
VALIDATION DOCUMENTATION
MVP & VP’s (MASTER VALIDATION PLAN & VALIDATION PLANS)
FAT & SAT (FACTORY ACCEPTANCE TESTS & SITE ACCEPTANCE TESTING)
URS (USER REQUIRMENT SPECIFICATION)
FDS (FUNCTIONAL DESIGN SPECIFICATION)
RTM (REQUIREMENT TRACEABILITY MATRIX)
IQ (INSTALLATION QUALIFICATION)
OQ (OPERATIONAL QUALIFICATION)
PQ (PERFORMANCE QUALIFICATION)
DEVIATION & DISCREPANCY HANDLING
VSR (VALIDATION SUMMARY REPORT)
GxP & RELATED TOPICS
GMP - GOOD MANUFACTURING PRACTICE
GLP - GOOD LABORATORY PRACTICE
GDP - GOOD DOCUMENTATION PRACTICE
QUALITY MANAGEMENT SYSTEMS - ISO 9001:2000
GEP - GOOD ENGINEERING PRACTICE
GAP - GOOD AUDITING PRACTICE - ISO 19011
DEFINITION & WHITE PAPER ZONE
GENERAL VALIDATION DEFINITIONS
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