Is V5 21 CFR Part 11 compliant?

V5 provides controls that support what EU inspectors look for under Annex 11 — support for validating the computerised system, risk-based change control, periodic review, incident management, and a full audit trail. Validation artefacts (URS, FS, IQ/OQ templates) are included for Enterprise tier customers.

FSMA Section 204 led to FDA's Food Traceability Rule (21 CFR Part 1, Subpart S), which requires records of Key Data Elements at Critical Tracking Events for foods on the Food Traceability List. The original compliance date was 20 January 2026; FDA has proposed moving it to 20 July 2028, and Congress has directed FDA not to enforce the rule before that date. Records must be provided within 24 hours of an FDA request, or a reasonable time FDA agrees to. V5 captures KDEs at receiving, transformation and shipping and can export them as a sortable spreadsheet.

ISO 13485:2016 is the international quality management system standard for medical devices, and since 2 February 2026 FDA's Quality Management System Regulation incorporates it by reference into 21 CFR 820. It covers document and record control, training, design controls, CAPA, supplier controls and risk management. V5 supports these in execution — training checks on steps, change control routed through approval, and records protected by an audit trail. Certification is held by the manufacturer, not by software.

Not by itself, provided the AI never signs. Part 11 requires an identifiable person to apply each electronic signature. In V5, AI can draft deviation investigations, suggest CAPA and summarise records, but an authorised person reviews the output before relying on it, and signatures and approvals stay with people through V5's existing controls.