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Is SciNote 21 CFR Part 11 compliant?

Yes, some of SciNote's premium plans are compliant with 21 CFR Part 11

SciNote's Premium plans offer the 21 CFR Part 11 add-on, which provides the features required to comply with FDA 21 CFR Part 11 — the federal regulation governing electronic records and electronic signatures.

The 21 CFR Part 11 add-on includes the following features:

  • Detailed audit trail — tracks all changes to records, including who made each change and when
  • Advanced user management — controls user roles, permissions, and access levels
  • Electronic signatures — enables legally compliant digital sign-offs on records and protocols
  • Electronic witnessing — allows a second authorized user to co-sign and verify records
  • Security features — including password expiration settings and system log records

Note: Visit the SciNote Trust Center to view and download SciNote's security and compliance documentation, including our ISO 27001 certification, 21 CFR Part 11 compliance standards, and more.

*Note: You will be asked to submit your contact information before accessing the documentation.

If you have any questions, please don't hesitate to contact us at support@scinote.net. For more info about Premium plans, request a quote.