> ## Documentation Index
> Fetch the complete documentation index at: https://docs.onestack.cloud/llms.txt
> Use this file to discover all available pages before exploring further.

# Standards and regulations

## 21 CFR Part 11

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  Status: Compliant (Enterprise License)
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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.

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

### Main Requirements

* [x] Strong Identity Checks for each Signature
* [x] Signature and Audit Trails
* [x] User Access Management
* [x] Quality Assurance Documentation

## SOC/ SOC II

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  Status: [Planned](https://github.com/documenso/backlog/issues/24)
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SOC II 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

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  Status: [Planned](https://github.com/documenso/backlog/issues/26)
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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).

### HIPAA

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  Status: [Planned](https://github.com/documenso/backlog/issues/25)
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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.