Standards and regulations
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
Main Requirements
- Strong Identity Checks for each Signature
- Signature and Audit Trails
- User Access Management
- Quality Assurance Documentation
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).
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).
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.