Free Tool FDA Life Sciences 21 CFR Part 11

FDA Audit Survival Score

21 CFR Part 11 Assessment

Rate your 21 CFR Part 11 readiness with this free scorecard. 12 criteria across 4 sections — get your audit survival score instantly.

FDA Audit Survival Score - 21 CFR Part 11 readiness assessment

Walk away with a concrete, actionable implementation plan.

General guidance for educational purposes only — not legal, regulatory, or compliance advice. Review results with qualified professionals.

1. Electronic Records

0 / 6
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

0 / 6
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

0 / 6
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

0 / 6
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

Rate all 12 criteria to see your score

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