Electronic Signature Part 11 Compliant with SignNow
Award-winning eSignature solution
Key performance indicators that demonstrate SignNow's proven track record.
What Part 11 compliant eSignatures are
An electronic signature part 11 compliant setup is an eSignature workflow designed to support FDA 21 CFR Part 11 expectations for electronic records and signatures. In practice, it combines user authentication, time-stamped audit trails, document history, and controlled access so a signed record stays traceable and tamper evident. signNow supports this kind of workflow with audit trails, mobile signing, and security controls that align with U.S. regulatory and business needs, including ESIGN and UETA validity for many transactions.
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Why Part 11 compliance matters
Electronic signature part 11 compliant workflows help teams sign documents faster while preserving evidence that supports U.S. enforceability under ESIGN and UETA. In regulated settings, the main value is traceability: it helps keep records attributable, time-stamped, and easier to defend during review or audit.
Security and compliance safeguards
Encryption:
Storage protection:
SOC 2 Type II:
ISO 27001:
GDPR controls:
Part 11 controls:
Recommended workflow settings
Use a simple, traceable setup that keeps signer identity, records, and retention rules aligned with regulated U.S. workflows.
| Setting | Recommendation |
|---|---|
| Authentication method | SMS OTP or ID verification |
| Signature type | Standard eSignature with audit trail |
| Audit trail | Enabled for every completed file |
| Document retention | 6 years for HIPAA records |
| Encryption | TLS 1.2/1.3 and AES-256 |
How the signing flow works
Here is the basic flow for a Part 11-aligned signing process in SignNow.
Prepare: Prepare the document and define signer order. Send: Send the request with the right authentication. Sign: Collect signatures and preserve each event. Archive: Archive the completed record with its trail.
Inside the audit trail
This section shows what a Part 11-oriented audit trail captures after a document moves through SignNow.
Authentication:
Timestamps:
Document hash:
Sealing:
Event log:
Export:
FAQs for Part 11 compliance
These answers focus on signNow features, plan limits, and the documentation needed to support regulated electronic signatures in the U.S.
SignNow supports audit trails, timestamps, and signer authentication on paid plans. For FDA-regulated records, 21 CFR Part 11 also expects validated systems, unique user IDs, and secure retention of signature history.
The Business plan includes legally binding eSignatures, audit trails, templates, and mobile apps. For HIPAA workflows, use a BAA and keep encryption at rest and in transit enabled.
Bulk send is listed with Business Premium. If your team needs high-volume routing, that tier adds bulk send, kiosk mode, request payments, and quick invite links.
For Part 11 evidence, preserve signer identity, timestamps, document history, and tamper-evident records. A strong audit trail helps support admissibility under ESIGN, UETA, and FRE 901.
If a document needs higher assurance, use added authentication such as SMS OTP or ID verification. For Part 11, unique identity and controlled access matter more than a drawn signature alone.
The Site License adds SSO, full API access, phone support, and HIPAA or 21 CFR options as add-ons. It fits larger deployments that need centralized user control.
Risks of weak Part 11 controls
Enforceability gaps
Missing trail
Part 11 failure
Signer attribution issue
Pricing and plan features across vendors
This snapshot compares entry pricing and a few compliance-oriented features for U.S. teams evaluating eSignature tools.
| Features | SignNow | DocuSign | Adobe Sign | PandaDoc | Dropbox Sign |
|---|---|---|---|---|---|
| Criteria | SignNow | DocuSign | Adobe Sign | PandaDoc | Dropbox Sign |
| Starting price | $8/user/mo, annual | $15/user/mo | $14/user/mo | $19/user/mo | $15/user/mo |
| Free trial | 7 days | Not verified | Not verified | Not verified | Not verified |
| Bulk send | Yes, Business Premium | Not verified | Not verified | Not verified | Not verified |
| Audit trail | Included | Included | Included | Included | Included |
| HIPAA compliance | BAA required | BAA available | BAA available | Not verified | Not verified |
Businesses that use Part 11 eSignatures
Different organizations adopt Part 11-aligned signing for different reasons, but they usually need control, traceability, and quicker document turnaround.
A solo medical practice can use SignNow for patient intake, consent, and release forms while keeping HIPAA workflows organized and audit-friendly. The low entry price and mobile apps help small teams avoid paper delays without adding layer upon layer of administration. A NetSuite or Salesforce operations team can route contracts, approvals, and vendor forms through centralized templates, delegated sending, and role-based access. That structure helps enterprise users keep signers, records, and permissions aligned with internal controls and review requirements. A construction or real estate office can collect bids, lease agreements, and closing documents on-site, then preserve the signing history for later review. Teams in those industries often need speed, mobile signing, and a clear record of who signed and when.
These tasks are executed by both individual contributors and centralized administrators depending on organizational policy and required controls.
Vendor comparison for regulated signing
The table below compares SignNow with two major vendors on pricing and a few procurement-relevant features.
| SignNow | DocuSign | Adobe Acrobat Sign | Recommended |
|---|---|---|---|
| Criteria | Recommended | DocuSign | Adobe Acrobat Sign |
| Starting price | $8/user/mo | $15/user/mo | $14/user/mo |
| Free trial | 7 days | Not verified | Not verified |
| Bulk send | Yes | Not verified | Not verified |
| Audit trail | Included | Included | Included |
| HIPAA compliance | BAA required | BAA available | BAA available |
Record-keeping practices that reduce risk
Good retention and evidence habits matter as much as the signing process itself, especially when the record may be reviewed months or years later.