---
title: Certifications & Regulatory Compliance
description: Documenso's compliance status for industry certifications and regulatory frameworks.
---

import { Callout } from 'fumadocs-ui/components/callout';

### Compliance Status Overview

| Certification  | Status                 |
| -------------- | ---------------------- |
| 21 CFR Part 11 | Compliant (Enterprise) |
| SOC 2          | Compliant              |
| ISO 27001      | Planned                |
| HIPAA          | Compliant (Enterprise) |

## 21 CFR Part 11

<Callout type="info">Status: Compliant (Enterprise License)</Callout>

21 CFR Part 11 is a regulation by the FDA that establishes the criteria for electronic records and electronic signatures to ensure their authenticity, integrity, and confidentiality in the pharmaceutical, medical device, and other FDA-regulated industries.

Read more about [21 CFR Part 11 with Documenso](https://documen.so/21-CFR-Part-11).

### Main Requirements

- Strong Identity Checks for each Signature
- Signature and Audit Trails
- User Access Management
- Quality Assurance Documentation

## SOC 2

<Callout type="info">Status: [Compliant](https://documen.so/trust)</Callout>

SOC 2 is a framework for managing and auditing the security, availability, processing integrity, confidentiality, and data privacy in cloud and IT service organizations, established by the American Institute of Certified Public Accountants (AICPA).

## ISO 27001

<Callout type="warn">Status: [Planned](https://github.com/documenso/backlog/issues/26)</Callout>

ISO 27001 is an international standard for managing information security, specifying requirements for establishing, implementing, maintaining, and continually improving an information security management system (ISMS).

## HIPAA

<Callout type="info">Status: [Compliant](https://documen.so/trust)</Callout>

The HIPAA (Health Insurance Portability and Accountability Act) is a U.S. law designed to protect patient health information's privacy and security and improve the healthcare system's efficiency and effectiveness.

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## See Also

- [Standards](/docs/compliance/standards) - Technical signing standards (PDF/A, PAdES, X.509)
- [Signature Levels](/docs/compliance/signature-levels) - eIDAS and other signature level compliance
- [Enterprise Edition](/docs/policies/enterprise-edition) - Enterprise licensing for compliance features
- [GDPR](/docs/compliance/gdpr) - Data protection compliance
