Life science organizations regulated by the Food and Drug Administration (FDA) are required to follow the Code of Federal Regulations Title 21 Part 11. The FDA has determined that while adherence to compliance with ESIGN and UETA is essential, there are further guidelines that also must be followed. 21 CFR Part 11 is an FDA regulation that outlines compliance requirements for electronic signatures and electronic records in these industries. This FDA regulation has two fundamental areas of enforcement: electronic signatures and electronic records.
Now send, sign, and approve documents anywhere with digitized documentation process. Cygnature supports life science organizations to stay compliant with e-signature practices set in 21 CFR Part 11 with well-crafted functionality and fully functional offerings. Cygnature’s standard-based approach makes it easier for organizations to integrate the electronic signatures in an alignment with Part 11 requirements, even into complex processes and systems.
- The decoding of the phrase “21 CFR Part 11”
- Digitize the documentation process
- Cygnature’s 21 CFR Part 11 module