About Computer System Validation Checklists

[muzafferekren (Muzaffer)]

Hi guys,
i have 21 CFR P11 check list. Its about CSV questions. Actually, i need more details questions or checklist about auidit trialing. Such as, “Is there any data loss?” , “Is data deletion made by an authorized user?”. i hope you can help me.

good work everyone.

[Ankur (Ankur Choudhary)]

Certainly, here are some additional questions/checklist items you may consider for audit trail reviews:

1. Are all user actions captured in the audit trail, including system logins, logouts, and changes to records?
2. Is the date and time stamp accurate and synchronized with the system clock?
3. Is the audit trail reviewed regularly, and are discrepancies or anomalies investigated?
4. Are there any gaps in the audit trail, and if so, is there a justification for the missing information?
5. Is the audit trail stored securely, with appropriate access controls in place to prevent unauthorized modification or deletion?
6. Are there any system-generated or automated events that are not captured in the audit trail?
7. Are there any changes made to the audit trail itself, and if so, are they properly documented and authorized?
8. Are there any duplicate entries or inconsistencies in the audit trail?
9. Are the audit trail requirements in compliance with regulatory guidelines and internal policies?
10. Are there any other critical events or actions that should be included in the audit trail?