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CFR Part 11 Module

CFR Part 11 signing for regulated teams

Support FDA-regulated signing workflows in a dedicated CFR Part 11 workspace with signer verification, signing reasons, Envelope History, and a validation pack.

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CFR Part 11 workspace for regulated eSignature workflows

What is 21 CFR Part 11?

21 CFR Part 11 sets FDA requirements for electronic records and electronic signatures used in regulated work. Nota Sign helps teams run controlled signing workflows with signer verification, signing intent, traceable records, and validation support.

Give regulated signing the right controls

Help teams move faster while preserving identity, intent, and evidence.

Dedicated CFR Part 11 workspace for regulated signing

Dedicated CFR workspace

Keep regulated workflows separate from everyday agreements with CFR Part 11 controls.
Signer verification for CFR Part 11 signing

Signer verification

Require account checks, OTP, or SSO-aligned access at key signing moments.
Envelope History for a regulated signing workflow

Envelope History records

Capture signer identity, signing reasons, timestamps, Envelope History, and audit reports.
Dedicated CFR Part 11 workspace for regulated signing

Dedicated CFR workspace

Keep regulated workflows separate from everyday agreements with CFR Part 11 controls.
Signer verification for CFR Part 11 signing

Signer verification

Require account checks, OTP, or SSO-aligned access at key signing moments.
Envelope History for a regulated signing workflow

Envelope History records

Capture signer identity, signing reasons, timestamps, Envelope History, and audit reports.
CFR Part 11 workspace settings for regulated teams

Run CFR workflows in their own workspace

Activate a dedicated CFR Part 11 workspace for regulated teams and manage members, permissions, and signing controls in one place. Teams can separate life sciences signing from everyday agreements without changing the core Nota Sign experience.
Signing reason selected before applying a CFR signature

Capture the reason behind every signature

Ask signers to select the meaning of each signature, such as review, approval, authorship, or confirmation. Administrators can manage approved reasons and allow controlled custom reasons when the workflow requires it.
Signer verification checkpoint for a CFR Part 11 envelope

Verify signers before critical actions

Support controlled signer verification with account authentication, email OTP rules, and SSO-aligned access where configured. Quick Sign can streamline approved workflows while preserving clear verification checkpoints.
Hybrid routing for sequential and parallel regulated approvals

Route approvals in sequence or parallel

Use signing order and Hybrid Routing to mirror real approval paths: one reviewer first, multiple reviewers in parallel, and final approval only after required steps are complete.
CFR Part 11 validation pack for GxP readiness

Support GxP readiness with a validation pack

Give quality, compliance, and CSV teams a structured CFR Part 11 Validation Pack for vendor assessment and workflow validation planning, including validation plans, requirements, risk assessment, test protocols, traceability, executed evidence, and summary reporting.

CFR Part 11 Module FAQs

Answers for life sciences and regulated teams evaluating CFR Part 11 signing workflows.

Support regulated signing with confidence

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Regulated signing workspace supported by Nota Sign