FDA 21 CFR Part 11 Checker
FDA 21 CFR Part 11 establishes requirements for electronic records and electronic signatures in FDA-regulated industries. This tool evaluates your compliance across electronic signatures, audit trails, system validation, access controls, and record retention to ensure your systems meet FDA requirements.
Progress: 0/23
Electronic Signatures
0/5Audit Trails
0/5System Validation
0/5Access Controls
0/5Record Retention & Integrity
0/3Electronic Signatures
Assessment of electronic signature uniqueness, authentication, and linkage requirements.
Q1
Are electronic signatures in your system uniquely tied to a single individual and never shared, reused, or reassigned to another person?
Q2
Before a user executes an electronic signature, does the system require entry of both a unique user ID and a password (or biometric) at the time of signing?
Q3
Does each electronic signature record include the printed name of the signer, the date and time of signing, and the meaning of the signature (e.g., approval, review, authorship)?
Q4
Are electronic signatures permanently linked to their respective electronic records such that the signature cannot be copied, detached, or transferred to falsify another record?
Q5
For non-biometric signatures, do you require at least two distinct identification components, with continuous session signing using at least one component per subsequent signature?
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