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