1. Type of documentation for computer system validation. 2.Please explain recent or current one software execution and computer sytem validation. 3. What is Security policy for GxP computerization system? 4.what is perform in tracebelity matrix? 5.ALCOA AND ALCOA+ 6. What is DATA integrity and explain data integrity point? 7. Explain 12 nos. Any regulatory point for 21 CFR part 11? 8.Explain GAMP5 ? 9. Defination for computer system validation as per GAMP5? 10.what is cyper security? 11 Type of software category? 12.What is risk assessment and explain rating, qualitative and quantitative risk assessment? 13.Explain sytem retirement plan ? 14.Explain vendor assessment and categorization ? 15.Explain GXP risk assessment, bussiness assessment,funtional risk assessment? 16. Explain deviation ,change control? 17.defination for latest current updated Quality Assurance,archieve,retrieve,electronic data,electronic signature,data,mera data, ? 18.what is a software architectural design? 19.define back up and restoration,schedule for backup and restoration,data retention and frequency for backup and restoration? 20 explain type of media used in backup and restoration? 21.difference between PLC vs. Application software. 22.explain stand alone software and server base software? 23.what is Data migration ? 24. What is Vplan? 25.explain scenario for installation of single software with minimum document and show fully compliance? 26.what is bussiness continuity plan? 27. Explain EU annexure 11 for computerization system? 28explain 5 example for manufacturing software and 5 example for laboratory software? 29.difference between PLC/HMI/SCADA/IPC/software and example for each? 30.explain schedule validation frequency?

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Technical Lead interview questions on computer system validation, documentation, security policy, data integrity, GAMP5, risk assessment, backup and restoration, software categories, and more.

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