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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 includes features needed for compliance with FDA’s regulation on electronic records and electronic signatures.

The features include a detailed audit trail, advanced user management, electronic signatures, electronic witnessing, and security features, such as password expiration settings and system log records.

Pro Tip – Access the SciNote Trust Center here, where you can view and download SciNote's security and compliance documentation, including our ISO 27001 certification, 21 CFR Part 11 compliance standards, and more!

*Requires you to provide information first to access 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.