FDA Audit Survival Score
21 CFR Part 11 Readiness Assessment
1. Electronic Records
Audit trails capture all record changes
Who, what, when, why for every modification
Records cannot be altered without detection
Tamper-evident controls in place
Record retention meets requirements
Accessible for required timeframe
2. Electronic Signatures
Signatures are unique to individuals
No shared credentials or signatures
Signatures linked to their records
Cannot be copied to other documents
Signature meaning documented
Review, approval, responsibility clear
3. System Validation
Systems validated for intended use
IQ/OQ/PQ documentation complete
Change control procedures in place
System changes documented and approved
Periodic revalidation performed
Ongoing verification of system compliance
4. Access Controls & Data Integrity
Role-based access controls implemented
Users only access what they need
Backup and recovery procedures tested
Data can be restored if needed
Security training documented
Staff trained on Part 11 requirements
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