feat: docs v2 (#2460)

Co-authored-by: Catalin Pit <catalinpit@gmail.com>
2026-07-24 17:04:12 +10:00 · 2026-02-27 22:05:27 +11:00
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+---
+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          | Planned                |
+
+## 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="warn">Status: [Planned](https://github.com/documenso/backlog/issues/25)</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.
+
+---
+
+## 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