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21 CFR Part 11

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

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Main Requirements

  • Strong Identity Checks for each Signature
  • Signature and Audit Trails
  • User Access Management
  • Quality Assurance Documentation

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SOC/ SOC II

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).

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ISO 27001

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

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.