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CSV Important Questions

This document contains 18 questions about computer system validation processes, including: how software is categorized; how change control flows work; how corrective and preventative actions are handled with an example; the procedure for implementing new software; the computer system validation flow; the differences between system and application audit trails; how to check Windows audit trails; server applications the person has experience testing; software handled in quality control, quality assurance, and manufacturing; relating ALCOA principles to computer system validation; what FRAP is; experience preparing user requirement specifications and system requirement specifications documents; what is mainly focused on in operational qualification protocols; how to relate requirements traceability matrices; the differences between FDA 21 CFR and Annex 11; how to handle disagree

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farooq pasha
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884 views1 page

CSV Important Questions

This document contains 18 questions about computer system validation processes, including: how software is categorized; how change control flows work; how corrective and preventative actions are handled with an example; the procedure for implementing new software; the computer system validation flow; the differences between system and application audit trails; how to check Windows audit trails; server applications the person has experience testing; software handled in quality control, quality assurance, and manufacturing; relating ALCOA principles to computer system validation; what FRAP is; experience preparing user requirement specifications and system requirement specifications documents; what is mainly focused on in operational qualification protocols; how to relate requirements traceability matrices; the differences between FDA 21 CFR and Annex 11; how to handle disagree

Uploaded by

farooq pasha
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Computer System Validation Life Cycle

1. Please explain how software categorization is done, which document support that
2. Can you explain the Change control flow,
3. Can you explain the CAPA with an example? “Deviation-validation”
4. If a software needs to be implemented in an organization can you explain the procedure
5. Explain the CSV Flow.
6. What is an audit trail, difference between system audit trail and application audit trail?
7. How can we check windows audit trail?
8. Which server applications have you worked with, have you involved in testing the Infrastructure Qualification.
9. What software’s have you handled in QC, QA, Mfg.
10. Can you relate and explain the ALCOA principles with CSV Validation.
11. What is FRAP?
12. Have you involved in preparing URS, SRS? When preparing those documents what documents you referred.
13. Can you tell what contents are mainly focused in OQ, protocol?
14. How do u relate and explain RTM.
15. What is difference between FDA 21 CFR and Annexure 11
16. How do you handle Co-workers and subordinates that disagree and directly refuse to apply/comply with a directive or a solution you
have provided?
17. What are the controls for 21 CFR part 11.
18. How do u verify and execute backup and restoration.

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