21 CFR Part 11 Compliant E-Signatures for Clinical Protocols
Every protocol approval in Avenio is backed by a legally valid, regulation-compliant electronic signature that captures signer identity, timestamp, IP address, and stated meaning — stored in an immutable audit trail.
Request a DemoEverything 21 CFR Part 11 requires — and nothing you don't need
Captures all required elements
Every signature records the signer's printed name, timestamp, IP address, and the stated meaning of the signature — satisfying all 21 CFR Part 11 requirements automatically.
Three signature methods
Draw, type, or upload a signature image. All three are legally equivalent under 21 CFR Part 11. The signer chooses their preferred method.
Multi-step approval chains
Configure role-based signing order with as many steps as your SOP requires. Each step must be completed before the next approver is notified.
Immutable signature records
Signatures cannot be altered or deleted after the fact. The audit trail is append-only — every action is preserved permanently.
Non-repudiation
Signers must authenticate before signing. The system records the authentication event, preventing later denial of having signed.
Linked to the specific record version
Each signature is cryptographically tied to the exact version of the protocol that was signed — so a later amendment cannot retroactively alter what was approved.
Frequently asked questions about 21 CFR Part 11
What does 21 CFR Part 11 require for electronic signatures?
21 CFR Part 11 requires that electronic signatures include: the printed name of the signer, the date and time of signing, and the meaning of the signature (e.g., approval, review, authorship). The system must also maintain an audit trail linking each signature to the specific record being signed, and signatures must be non-repudiable — meaning signers cannot later deny having signed.
How does Avenio's e-signature workflow work?
When a protocol reaches the signature stage, Avenio routes it to the designated approvers in the configured order. Each approver receives a notification, reviews the protocol, provides their signature (drawn, typed, or uploaded), and states the meaning of their signature. Avenio captures their identity, timestamp, IP address, and stated reason — all stored in an immutable audit trail.
Can an electronic signature be revoked or altered after signing?
No. Signatures in Avenio are immutable once applied. The audit trail records cannot be modified or deleted. If a protocol needs to be revised after signing, a new amendment must be created and go through its own approval and signature workflow.
What signature methods does Avenio support?
Avenio supports three signature methods: draw (freehand on screen), type (typed name rendered in a signature font), and upload (upload an existing signature image). All three methods produce legally equivalent signatures under 21 CFR Part 11.
Does Avenio support multi-step approval workflows?
Yes. Avenio supports configurable multi-step approval chains with role-based signing order. For example: Medical Writer → Clinical Scientist → Biostatistician → Medical Director. Each step must be completed before the next approver is notified.
See the signature workflow live
Request a demo and walk through the full approval and signature flow.
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