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48 lines
1.7 KiB
Plaintext
48 lines
1.7 KiB
Plaintext
import { Callout } from 'nextra/components';
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## 21 CFR Part 11
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<Callout type="info" emoji="✅">
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Status: Compliant (Enterprise License)
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</Callout>
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21 CFR Part 11 is a regulation by the FDA that establishes the criteria for electronic records and electronic
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signatures to ensure their authenticity, integrity, and confidentiality in the pharmaceutical, medical
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device, and other FDA-regulated industries.
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> Read more about 21 CFR Part 11 with Documenso here: https://documen.so/21-CFR-Part-11
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### Main Requirements
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- [x] Strong Identity Checks for each Signature
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- [x] Signature and Audit Trails
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- [x] User Access Management
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- [x] Quality Assurance Documentation
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## SOC/ SOC II
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<Callout type="warning" emoji="⏳">
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Status: [Planned](https://github.com/documenso/backlog/issues/24)
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</Callout>
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SOC II is a framework for managing and auditing the security, availability, processing integrity, confidentiality,
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and data privacy in cloud and IT service organizations, established by the American Institute of Certified
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Public Accountants (AICPA).
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## ISO 27001
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<Callout type="warning" emoji="⏳">
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Status: [Planned](https://github.com/documenso/backlog/issues/26)
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</Callout>
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ISO 27001 is an international standard for managing information security, specifying requirements for
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establishing, implementing, maintaining, and continually improving an information security management
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system (ISMS).
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### HIPAA
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<Callout type="warning" emoji="⏳">
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Status: [Planned](https://github.com/documenso/backlog/issues/25)
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</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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