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Computer System Validation
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Computer System Validation
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H. DESIGN SPECIFICATION
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J. DESIGN QUALIFICATION (DQ)
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Chapter
COMPUTER SYSTEM VALIDATION
VALIDATION PROCESS
CONCEPT PHASE
GAMP 5 SOFTWARE CATEGORIES
APPROACH FOR CATEGORY 3 – NON-CONFIGURED PRODUCTS
APPROACH FOR CATEGORY 4 – NON-CONFIGURED PRODUCTS
APPROACH FOR CATEGORY 5 – NON-CONFIGURED PRODUCTS
GXP IMPACT ASSESSMENT AND GAMP 5
RESPONSIBILITIES OF CSV
PRINCIPLES OF GAMP 5
GAMP 5 APPROACH
WHAT IS COMPUTERIZED SYSTEM VALIDATION (CSV)
REQUIREMENTS OF CSV
CSV APPROACH CRITICAL – THINKING ASSURANCE TESTING ACTIVITIES
TYPICAL CSV DELIVERABLE GAMP5 V – MODEL
PHASE WISE DELIVERABLE AND ACTIVITIES
SPECIFICATION DESIGN AND VERIFICATION PROCEDURE OF CSV
CSV LIFE CYCLE
PROJECT PHASE OF CSV – A. SUPPLIER ASSESSMENT
B.RISK MANAGEMENT
C. VALIDATION PLAN
D. SYSTEM OVERVIEW
E. USER REQUIREMENT SPECIFICATION
F. FUNCTIONAL SPECIFICATION
G. CONFIGURATION SPECIFICATION
H. DESIGN SPECIFICATION
I. DESIGN REVIEW
J. DESIGN QUALIFICATION (DQ)
K. INSTALLATION QUALIFICATION (IQ)
L. OPERATIONAL QUALIFICATION (OQ)
M. PERFORMANCE QUALIFICATION (PQ)
N. SYSTEM OPERATING PROCEDURES / USER MANUALS
0. TRAINING
P. SYSTEM SUPPORT PLAN
Q. SERVICE LEVEL AGREEMENT
R. SYSTEM HANDOVER AND SYSTEM RELEASES
S. THE VALIDATION REPORT
INTORUCTION FOR EVALUATION
18. EVALUATION QUESTIONNAIRE
10 questions
