Free Tool FDA Life Sciences 21 CFR Part 11

FDA Audit Readiness Score

21 CFR Part 11 Assessment

Rate your 21 CFR Part 11 readiness with this free assessment tool. Get your audit survival score from centrexIT.

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.

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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