21 CFR Part 11 Compliant SignNow's CRM Vs Close CRM

Check out the reviews of the airSlate SignNow CRM vs. Close CRM to compare the benefits, features, tools, and pricing of each solution.

No credit card required
See how it works!Click here to sign a sample doc

Award-winning eSignature solution

What 21 CFR Part 11 compliance means for signNow's CRM vs Close CRM

21 CFR Part 11 defines FDA expectations for electronic records and electronic signatures used in regulated industries, including pharmaceuticals, medical devices, and clinical research. When comparing signNow's CRM integration to Close CRM, focus on controls that support signature authenticity, traceability, and record integrity. Key elements include user identity verification, secure audit trails, tamper-evident storage, and retention policies aligned with regulatory requirements. Organizations also consider alignment with ESIGN and UETA for transactional validity and how each platform documents procedural controls, system validation, and change-management activities required for inspection readiness.

Why compliance-focused eSignature choice matters

Selecting an eSignature solution with explicit Part 11 controls reduces regulatory risk, streamlines audit response, and preserves the legal validity of electronic records used in FDA-regulated workflows.

Why compliance-focused eSignature choice matters

Common compliance and implementation challenges

  • Establishing system validation documentation that satisfies FDA expectations can be time-consuming and requires cross-functional input.
  • Ensuring consistent, auditable user authentication across remote signers without introducing excessive friction.
  • Implementing retention and archival policies that meet both Part 11 and company record-keeping schedules.
  • Reconciling CRM-integrated signature events with existing SOPs and electronic quality systems for inspections.

Representative user roles

Clinical QA Manager

Oversees document control and validation activities, defines Part 11 requirements, reviews audit trails, and ensures SOPs map to electronic signing workflows for regulatory inspections.

IT Systems Administrator

Implements integrations, enforces authentication methods, configures retention and backup, maintains role-based permissions, and supports system validation artifacts and change control.

Typical users and teams involved

  • Quality assurance professionals responsible for validation and SOP alignment.
  • Clinical operations teams sending consent and study documents for signature.
  • IT and security teams managing integration, access control, and audits.

Procurement and legal stakeholders often evaluate contractual and privacy terms to ensure the solution meets organizational and regulatory obligations.

Additional capabilities impacting compliance and operations

Beyond core controls, these additional capabilities influence validation scope, operational efficiency, and inspection readiness for regulated teams.

Role Permissions

Granular role and permission settings allow administrators to restrict document actions to authorized personnel and reduce unauthorized access risk.

API Accessibility

APIs enable automation of document generation, signature triggering, and archival within validated workflows and system-of-record architectures.

Template Management

Centralized templates maintain consistent document structure and reduce variability that complicates validation and SOP enforcement.

Bulk Send

Bulk sending for mass distribution supports consistent delivery while maintaining individual audit records for each recipient.

Encryption Controls

Strong encryption at rest and in transit protects sensitive content during transfer and storage across integrated systems.

Reporting Tools

Built-in reporting supports monitoring of signing activity, compliance metrics, and evidence needed for audits.

be ready to get more

Choose a better solution

No credit card required

Four compliance-focused features to compare

These features are commonly required when assessing Part 11 capability in an eSignature solution integrated with CRM platforms.

Audit Trail

Comprehensive, tamper-evident audit trails record signer identity, timestamps, IP addresses, and event history to support inspections and internal reviews.

Authentication

Flexible authentication options include single sign-on, multi-factor authentication, and configurable identity verification to meet organizational risk profiles.

Document Integrity

Cryptographic hashing and document locking prevent post-signature edits and provide verifiable integrity checks during retrieval and review.

Retention Controls

Configurable retention and archival policies enable retention periods and exports consistent with company SOPs and regulatory expectations.

How CRM-integrated Part 11 workflows operate

Overview of the typical flow when generating, sending, and archiving Part 11-relevant documents through a CRM-integrated eSignature solution.

  • Create Document: Generate form from CRM record.
  • Authenticate Signer: Verify identity before signing.
  • Capture Signature: Record signed event and metadata.
  • Archive Record: Store immutable record in archive.
Collect signatures
24x
faster
Reduce costs by
$30
per document
Save up to
40h
per employee / month

Step-by-step: Setting up a compliant signature workflow

A concise setup sequence to establish a Part 11-aware signing process using an eSignature integrated with your CRM.

  • 01
    Define Scope: Identify regulated documents and owners.
  • 02
    Assign Roles: Map approvers and signers to roles.
  • 03
    Configure Auth: Enable MFA and SSO where required.
  • 04
    Validate System: Document IQ/OQ/PQ testing.

Audit trail management: key steps

Concise steps to ensure audit trails meet Part 11 expectations and support inspections.

01

Enable Logging:

Turn on detailed event logging.
02

Secure Storage:

Use immutable archives.
03

Regular Review:

Schedule audits of logs.
04

Export Controls:

Provide exportable evidence formats.
05

Time Synchronization:

Ensure consistent timestamps.
06

Retention Scheduling:

Apply policy-based retention.
be ready to get more

Why choose airSlate SignNow

  • Free 7-day trial. Choose the plan you need and try it risk-free.
  • Honest pricing for full-featured plans. airSlate SignNow offers subscription plans with no overages or hidden fees at renewal.
  • Enterprise-grade security. airSlate SignNow helps you comply with global security standards.
Start free trial
illustrations signature

Typical configuration settings for a Part 11 workflow

Standardized settings help ensure consistent behavior across regulated signature processes and simplify validation scope.

Workflow Setting Name Header Row Configuration Value
Signature Validation Mode Setting Config Strict validation
User Authentication Requirement Setting MFA enforced
Audit Trail Retention Setting Policy 7 years
Document Integrity Check Frequency Setting On access
Automated Backup and Export Schedule Setting Daily snapshot

Supported platforms and device considerations

  • Windows and macOS: Modern browsers
  • iOS and Android: Mobile app or browser
  • Network Requirements: TLS 1.2+ connections

Validate device behavior during system qualification, including authentication flows, PDF rendering, and local caching to prevent evidence gaps across platforms.

Core security controls to inspect

Access Controls: Role-based access
Authentication: Multi-factor options
Encryption: At-rest and in-transit
Audit Trails: Immutable event logs
Data Integrity: Checksum verification
Backup & Recovery: Redundant snapshots

Industry use cases showing Part 11 controls

Two concise case summaries illustrate how Part 11-capable eSignature workflows are applied across regulated environments.

Clinical Trial Consent

A clinical operations team needed remote informed consent with verifiable signatures and retention

  • integration with CRM and eSignature to capture signer identity
  • operational benefit was reduced study start delays and clearer audit records

Resulting in faster inspection readiness and fewer protocol deviations.

Device Release Approvals

A medical device manufacturer routed lot release forms through CRM-linked signatures for technical approvals

  • enforced MFA and role checks at approval steps
  • achieved clearer chain-of-custody and fewer manual handoffs

Leading to improved traceability and simplified FDA submission support.

Best practices for secure and auditable Part 11 workflows

Practical controls and habits that reduce risk, simplify validation, and improve inspection readiness across CRM-integrated signature processes.

Documented validation and traceability practices
Maintain a complete validation package linking user requirements to test cases and results. Include integration tests for CRM triggers, signature capture, and archival exports. Keep traceability matrices and change-control logs current to expedite audits and inspections.
Consistent authentication and role enforcement
Use enterprise SSO and multi-factor authentication for signers and approvers. Align CRM roles with signature permissions and limit administrative privileges to reduce the risk of unauthorized actions.
Immutable audit trails and periodic review
Ensure audit trails are tamper-evident and routinely reviewed for anomalies. Include checks for missing events, time skew, and unexpected user activity as part of routine compliance monitoring.
Retention, backup, and disaster recovery alignment
Implement automated backups, geographic redundancy, and tested recovery procedures. Document retention schedules and ensure archived records remain accessible and readable for the full retention period.
Connect airSlate SignNow to your apps
Check out airSlate SignNow integrations
Data accuracy, security, and compliance
airSlate SignNow is committed to protecting your sensitive information by complying with global industry-specific
Learn more about security

FAQs and troubleshooting for Part 11 workflows

Answers to common questions and practical troubleshooting tips for implementing and maintaining Part 11-capable eSignature processes.

Quick feature comparison: signNow vs Close CRM vs DocuSign

A compact comparison of compliance-relevant capabilities for signNow, Close CRM, and DocuSign used in regulated US workflows.

Feature / Criteria signNow Close CRM DocuSign
Part 11-focused controls Limited
Audit trail detail Extensive Basic Extensive
MFA support Dependent
API for automated evidence Full API Partial API Full API
be ready to get more

Get legally-binding signatures now!

Start your free trial

Retention and archival timelines to consider

Typical retention schedules and archival checkpoints relevant to Part 11 records and CRM-integrated document lifecycles.

Short-term access window:

90 days for rapid retrieval and correction workflows.

Regulatory retention period standard:

7 years standard for many regulated records.

Clinical study record retention:

Retain through study life plus 2–5 years per SOP.

Backup verification cadence:

Monthly integrity checks and restores.

Disposition review schedule:

Annual review for decommissioning or extension.

Regulatory risks and potential penalties

Record Noncompliance: Warning letters
Data Integrity Failure: Product holds
Inspection Deficiencies: Remediation orders
Legal Exposure: Liability claims
Operational Disruption: Delayed approvals
Reputational Harm: Market distrust

Pricing and plan comparison across vendors

High-level pricing and compliance feature availability for signNow, Close CRM, DocuSign, Adobe Sign, and PandaDoc to inform procurement comparisons.

Entry-level per-user pricing signNow: $8–$12 monthly Close CRM: $25–$99 monthly DocuSign: $10–$40 monthly Adobe Sign: $14–$30 monthly PandaDoc: $19–$49 monthly
Enterprise compliance package cost signNow: custom enterprise pricing Close CRM: add-on services pricing DocuSign: enterprise tiers available Adobe Sign: enterprise plans available PandaDoc: enterprise pricing
API access availability signNow: included on paid plans Close CRM: available on select plans DocuSign: available on most plans Adobe Sign: available PandaDoc: included on higher tiers
Dedicated support options signNow: enterprise support options Close CRM: priority support tiers DocuSign: premium support packages Adobe Sign: enterprise support PandaDoc: priority support
Compliance documentation availability signNow: validation & compliance docs Close CRM: limited guidance DocuSign: extensive compliance docs Adobe Sign: comprehensive docs PandaDoc: moderate documentation
Onboarding and validation services signNow: validation assistance services Close CRM: third-party validation needed DocuSign: professional services Adobe Sign: professional services PandaDoc: consulting options
walmart logo
exonMobil logo
apple logo
comcast logo
facebook logo
FedEx logo

Explore Advanced Features

Discover More eSignature Tools

be ready to get more

Get legally-binding signatures now!

Start free trial
Company
Forms
Pricing
Resources
Knowledge base
Products
© 2026 airSlate Inc. All rights reserved.
English