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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
