What is electronic signature 21 CFR Part 11

TL;DR

Electronic signatures under 21 CFR Part 11 are legally accepted digital signatures for FDA-regulated records when controls ensure signer identity, signature integrity, and reliable audit trails. signNow supports 21 CFR Part 11 workflows by providing timestamped eSignatures, two-factor authentication, secure storage (AES-256), detailed audit logs, and configurable signer authentication. Use signNow to fill and sign FDA-related forms, route approvals in order, retain compliant records, and produce an auditable history while integrating signatures into existing systems via API and cloud connectors.

Plain explanation of 21 CFR Part 11 eSignatures

An electronic signature under 21 CFR Part 11 is simply a way to sign regulatory records on a computer or phone so the FDA treats them like a handwritten signature. Imagine signing a paper form but instead clicking or drawing your name on a secure digital page; the system then proves who signed, when, and whether the document changed after signing. Formally, Part 11 requires controls for identity verification, signature linking to records, audit trails, and system access controls so signed electronic records are trustworthy and admissible in FDA inspections and submissions.

Legal basis and practical triggers

Use signNow when closing remote sales contracts or collecting employee onboarding signatures at scale. 21 CFR Part 11 compliance matters for pharmaceutical, biotech, and medical device records because it preserves record integrity, documents signer intent, and supports FDA inspections or audits.

Common compliance and workflow obstacles

• Inconsistent signer authentication can produce noncompliant records and fail FDA inspection standards without clear identity proofing.
• Weak audit trails make it impossible to prove when a signature was applied or whether the document changed after signing.
• Uncontrolled document versions across email streams lead to duplicate records and unclear authoritative files during audits.
• Proprietary or offline signing tools that lack secure storage increase risk of data loss and chain-of-custody gaps.

Organizations and teams that rely on 21 CFR Part 11 eSignatures

Regulated companies and their supporting teams need reliable eSignature workflows to meet audit and recordkeeping obligations.

• Pharmaceutical manufacturers executing batch records and release approvals.
• Clinical operations collecting informed consent and study documentation.
• Quality assurance teams enforcing change control signoffs and traceability.

Representative user profiles

Brian Fitzgibbons, COO

Operational leaders who manage document throughput use signNow to reduce cycle times and maintain consistent audit trails. They configure signer order, enable two-factor authentication, and ensure that completed records are securely archived for inspection readiness and internal compliance reviews.

Kodi-Marie Evans, Director

Integration and IT leads use signNow to automate signature requests within NetSuite and other ERPs. They implement API-driven sending, map signed PDFs back to record systems, and enforce access controls so electronic records remain traceable and tamper-evident.

Core security and compliance controls

Encryption in transit: TLS 1.2 and TLS 1.3

Encryption at rest: AES-256 encryption

Certifications available: SOC 2 Type II report

Regulatory compliance: 21 CFR Part 11 compliant

Health data support: HIPAA compliant, BAA required

Accessibility standard: WCAG 2.0 Level AA

Real-world implementation examples

Two customer examples illustrate how signNow supports compliant eSigning and integration with enterprise systems.

Optica Ventures LLC

The interface is simple and easy-to-use for the internal team and external clients.

• The team uses signNow to get signatures remotely and maintain audit-ready records.
• That streamlined remote signing reduces handoff delays and ensures each signature is timestamped and linked.

Resulting in faster closings and reliable documentation for compliance and reporting.

Xerox (NetSuite integration)

airSlate SignNow provides needed flexibility to collect signatures in multiple formats and flow them back to NetSuite.

• The integration automates sending documents and retrieving signed PDFs into ERP records.
• That reduces manual upload tasks and keeps financial and customer records consistent.

Leading to fewer reconciliation errors and faster transaction completion across systems.

Step-by-step: prepare and eSign Part 11 records

This simple, sequence-driven guide helps nontechnical users prepare, send, and archive compliant electronic signatures using signNow.

• 01
  Upload Document: Open signNow, choose Upload, and select the PDF or form file from your device.
• 02
  Add Fields: In the editor, drag signature, date, and text fields to the required locations on the form.
• 03
  Configure Authentication: Set signer authentication options such as email, SMS code, or two-factor authentication before sending.
• 04
  Send for eSignature: Choose recipient order, add instructions, then click Send to initiate the signing workflow.

How sending and signing workflows operate

Understand the main workflow stages so your team consistently produces auditable, unalterable signed records with signNow.

• Prepare Form: Upload file, apply signature and data fields, and add conditional logic if needed.
• Authenticate Signers: Select email, SMS, or knowledge-based authentication and enable two-factor authentication.
• Collect Signatures: Recipients receive an email link, complete fields, and apply eSignatures on any device.
• Archive Record: Signed PDF and audit trail are stored securely with tamper-evident protections.

Primary features for Part 11 compliance

signNow includes several features that map directly to Part 11 controls, making it practical to collect, authenticate, and preserve FDA-regulated electronic records.

Audit Trail

Comprehensive event history records signer IPs, timestamps, actions, and document changes with clear, exportable logs to support inspections and internal audits.

Two-Factor Auth

Optional SMS or email code verification adds a second authentication factor to confirm signer identity before the eSignature is applied.

Tamper Evidence

Signed documents are locked with integrity checks so any post-signing modification is detectable, preserving evidentiary value for regulatory review.

Role-Based Access

Administrative controls restrict who can send, sign, view, or export records to maintain separation of duties and protect sensitive workflows.

Operational best practices for Part 11 records

Adopt consistent procedures and configuration steps to reduce audit risk and make inspections straightforward when using eSignatures.

Establish documented SOPs for eSignatures

Create standard operating procedures that define when to use eSignatures, who may approve, required authentication methods, and retention durations to ensure repeatable compliance practices.

Enable multi-factor authentication

Require two-factor authentication for high-risk signers or signings; this reduces impostor risk and strengthens the link between identity and signature events for regulatory records.

Maintain version control and templates

Use locked templates for regulated forms and track changes through version history so the organization can quickly demonstrate the authoritative form used at each signature event.

Regularly review audit logs

Schedule periodic reviews of signature audit trails and access logs to detect anomalies, confirm policy adherence, and prepare evidence for internal or external audits.

Typical timelines and record retention prompts

Common regulatory deadlines and retention points help teams set reminders and retention rules inside signNow and connected systems.

Batch record approvals due:

30 days before audit

Clinical consent archiving:

Retain per protocol duration

Annual SOP review:

12 months

Corrective action signoff deadline:

Within 14 days

Regulatory record retention:

Follow site-specific legal retention

Advanced features relevant to 21 CFR Part 11

Beyond core controls, several advanced signNow capabilities help automate compliance, integrate records, and support enterprise IT requirements.

SSO

Single sign-on integrates with corporate identity providers to centralize authentication and reduce credential management risks across regulated user populations.

API Access

Full API enables programmatic sending, retrieval, and archival of signed documents, allowing direct integration with LIMS, ERPs, and QMS systems.

Conditional Fields

Show or hide fields based on answers to ensure only relevant data is collected and reduce erroneous entries on regulated forms.

Bulk Send

Send identical documents to many recipients while preserving individualized audit trails for each signer and response.

Kiosk Mode

On-site signing mode supports shared devices while capturing signer identity and session details in a structured manner.

Phone Authentication

Phone-based verification options link a verified phone number to the signer for stronger identity assurance.

Audit trail setup and management steps

Follow these steps to ensure audit trails are enabled, stored, and retrievable for Part 11 records managed in signNow.

01

Enable Audit Logging:

Turn on detailed event logging in the admin console for signature events.

02

Configure Retention:

Set retention period and archival rules for signed records and logs.

03

Export Logs:

Use built-in export to download audit reports for inspections or reviews.

04

Restrict Access:

Limit who can view or export audit logs via role permissions.

05

Validate Integrity:

Perform checksum or signature validation on stored PDFs to confirm no tampering.

06

Document Procedures:

Record how audit trails are generated and reviewed for compliance evidence.

FAQs and troubleshooting for eSignature workflows

This FAQ addresses typical problems administrators and signers encounter when implementing 21 CFR Part 11 compliant eSigning with signNow.

• Why is a signature not accepted?
  Check signer authentication settings and required fields. Ensure the signer completed all mandatory fields and completed any configured two-factor authentication. Verify that the document was signed using the platform's signature field rather than an uploaded image, because Part 11 requires system-linked signature events.
• How do I prove signer identity?
  Use signNow's two-factor authentication options such as SMS or authenticator apps. Optionally require identity verification steps in the workflow. Combine with SSO for enterprise identity federation to link signatures to a corporate identity record.
• Where is the audit trail stored?
  Audit trails are stored alongside the signed PDF within signNow's secure storage and can be exported as part of the document package or admin reports for inspection and long-term archival.
• What if a signer loses access to their email?
  Reassign the signing step or resend the request to an alternate verified address. For critical records, revoke old requests and issue a new workflow to preserve a clean audit trail without ambiguous signer activity.
• Can offline signing be used for Part 11 records?
  signNow supports offline signing via mobile apps; however, ensure the app synchronizes signed records and audit details back to secure storage before considering the record complete for regulatory purposes.
• How to prepare for an FDA inspection?
  Export signed records with associated audit trails, document SOPs for eSignature use, and ensure authentication and access control logs are available to demonstrate compliance during inspection.

Supported platforms and access methods

signNow runs in modern web browsers, native mobile apps, and via APIs for automated integrations with enterprise systems.

• Web browser: Chrome, Edge, Safari
• Mobile apps: iOS and Android
• APIs and integrations: REST API and connectors

For regulated environments, use SSO and API integrations to centralize authentication and ensure signed records are archived in your compliance systems.

Typical workflow configuration for Part 11 records

A baseline workflow configuration that teams commonly use to meet Part 11 controls while collecting signatures with signNow.

Setting Name	Configuration
Signer Authentication Method	Email + SMS
Signer Order	Sequential
Audit Trail Retention	7 years
Document Locking	Enabled
Notification Reminders	48 hours

Feature availability: signNow vs major vendors

A concise feature-level comparison across signNow, DocuSign, and Adobe Sign to help evaluate Part 11 readiness and essential capabilities.

Feature / Vendor	signNow	DocuSign	Adobe Sign
Audit Trail	yes, detailed
Two-Factor Auth
API Access	full rest api	full api	full api
Bulk Send

Pricing and plan features comparison (data as of 2026)

Key pricing and capability comparison across signNow and competitors. Prices reflect annual billing where noted and common compliance-related features.

	$8/user/mo	$8/user/mo	$13/user/mo	$19/user/mo	$15/user/mo
Free Trial	7-day free trial no CC	Trial varies	Trial varies	Trial varies	Trial varies
Bulk Send	Bulk send on Premium plans	Available on higher plans	Enterprise only	Yes, paid plans	Yes, paid plans
Audit Trail	Comprehensive exportable logs	Yes	Yes	Yes	Yes
HIPAA Compliant	Yes, BAA required	Yes, BAA required	Yes, BAA required	Varies by plan	Varies by plan
Envelope Cap	No envelope cap	100 envelopes/user/year	No envelope cap	No envelope cap	No envelope cap