21 CFR Part 11 Compliance

FDA 21 CFR Part 11 sets criteria for electronic records and electronic signatures in regulated environments. When Tallyfy is used in a regulated setting, Part 11 compliance is a shared responsibility: Tallyfy provides platform capabilities that support Part 11, and the customer configures, validates, and operates them under its own quality procedures.

This page is provided for general information only. It does not form part of any contract and does not create any representation, warranty, or commitment.

Shared responsibility

Tallyfy, as the SaaS provider, offers platform capabilities relevant to Part 11, including audit trails, access controls, electronic signature support, and data export. Tallyfy also maintains a SOC 2 Type II attestation over its control environment.

The customer, as the regulated entity, is responsible for validating Tallyfy for its intended use, configuring and enforcing procedural controls, managing user access, reviewing audit data, and retaining records in line with its regulatory obligations.

No FDA certification exists

There is no formal FDA "certification" for 21 CFR Part 11. Each regulated organization remains responsible for validating its own systems and for maintaining the procedural controls and documentation that demonstrate its compliance.

Contact

If your organization needs to discuss using Tallyfy in a 21 CFR Part 11 context, please contact us.