Computerized system validation (CSV) in Pharmaceutical industry l 25 Interview Question

Computerized system validation (CSV) in Pharmaceutical industry l 25 Interview Question
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Questions covered:
Q. What is computerized system validation?
Q. What is computer system and computerized systems?
Q. What is importance of GAMP 5 in computer system validation?
Q. What are the five software categories as per GAMP 5?
Q. What is the five step approach to risk Management for computerized system as per GAMP 5?
Q. Who is system owner and process owner as per GAMP 5?
Q. What are the two hardware categories?
Q. What are the key concepts applied for computerized system?
Q. What are the life cycle phases of computerized system?
Q. What are the requirements for backup and restore as per GAMP 5
Q. What are the advantages of periodic evaluation of operational system?
Q. What is security management?
Q. What is patch and update management?
Q. What is periodic review of computerized systems as per GAMP 5?
Q. What are the computerized system validation activities?
Q. What are Open systems and closed systems?
Q. When we should perform GxP assessment in computer system validation?
Q. Who is SME or subject matter expert?
Q. What is computerized system withdrawal?
Q. What should be covered in the VMP?
Q. What are the three options for supplier assessment?
Q. What should be covered in Traceability Matrix?
Q. What should be covered in the validation approach of category 3 software?
Q. What is V model as per GAMP 5?
Q. Do I need to validate computerized system?
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