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58 lines
2.4 KiB
Plaintext
58 lines
2.4 KiB
Plaintext
---
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title: Certifications & Regulatory Compliance
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description: Documenso's compliance status for industry certifications and regulatory frameworks.
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---
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import { Callout } from 'fumadocs-ui/components/callout';
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### Compliance Status Overview
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| Certification | Status |
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| -------------- | ---------------------- |
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| 21 CFR Part 11 | Compliant (Enterprise) |
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| SOC 2 | Compliant |
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| ISO 27001 | Planned |
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| HIPAA | Compliant (Enterprise) |
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## 21 CFR Part 11
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<Callout type="info">Status: Compliant (Enterprise License)</Callout>
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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.
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Read more about [21 CFR Part 11 with Documenso](https://documen.so/21-CFR-Part-11).
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### Main Requirements
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- Strong Identity Checks for each Signature
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- Signature and Audit Trails
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- User Access Management
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- Quality Assurance Documentation
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## SOC 2
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<Callout type="info">Status: [Compliant](https://documen.so/trust)</Callout>
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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).
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## ISO 27001
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<Callout type="warn">Status: [Planned](https://github.com/documenso/backlog/issues/26)</Callout>
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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).
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## HIPAA
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<Callout type="info">Status: [Compliant](https://documen.so/trust)</Callout>
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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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---
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## See Also
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- [Standards](/docs/compliance/standards) - Technical signing standards (PDF/A, PAdES, X.509)
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- [Signature Levels](/docs/compliance/signature-levels) - eIDAS and other signature level compliance
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- [Enterprise Edition](/docs/policies/enterprise-edition) - Enterprise licensing for compliance features
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- [GDPR](/docs/compliance/gdpr) - Data protection compliance
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