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documenso/apps/documentation/pages/users/compliance/standards-and-regulations.mdx
Catalin Pit 8367878395 feat: documentation site (#1101)
## Description

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## Related Issue

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## Changes Made

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- Change 1
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## Testing Performed

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## Checklist

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- [ ] I have tested these changes locally and they work as expected.
- [ ] I have added/updated tests that prove the effectiveness of these
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<!-- This is an auto-generated comment: release notes by coderabbit.ai
-->
## Summary by CodeRabbit

- **Documentation**
- Enhanced project README for clarity and improved environment variables
section.
- Added comprehensive developer and user documentation, including guides
on local development, public API, self-hosting, and compliance
standards.
- Introduced specific guides for contributing, creating API keys, using
webhooks, and setting up security measures.
- Detailed documentation on various fields available for document
signing to improve user understanding.
- Added metadata structuring to improve navigation within the
documentation site.

- **Chores**
  - Updated `.gitignore` to better handle project files.

- **New Features**
- Introduced detailed metadata and documentation for various Documenso
functionalities, including signing documents, user profiles, and
compliance levels.
- Added functionality for Direct Link Signing, enabling easy sharing for
document signing.
<!-- end of auto-generated comment: release notes by coderabbit.ai -->

---------

Co-authored-by: Timur Ercan <timur.ercan31@gmail.com>
Co-authored-by: Lucas Smith <me@lucasjamessmith.me>
Co-authored-by: David Nguyen <davidngu28@gmail.com>
2024-07-22 13:34:37 +02:00

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import { Callout } from 'nextra/components';
## 21 CFR Part 11
<Callout type="info" emoji="✅">
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.
### 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
<Callout type="warning" emoji="⏳">
Status: [Planned](https://github.com/documenso/backlog/issues/24)
</Callout>
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
<Callout type="warning" emoji="⏳">
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="warning" emoji="⏳">
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.