Does using AI break 21 CFR Part 11 compliance?

Software alone can't make a company Part 11 compliant, but V5 provides the technical controls: identity-verified e-signatures on gated steps, an immutable audit trail with hash-chained record versions, role-based access and signed PDF renderings of batch records. The Part 11 assessment page summarises an independent assessment of V5 Ultimate 5.10 by Dr R.D. (Bob) McDowall (approved 25 September 2026), which reports the technical controls as compliant for manufacturing automation; QMS and QC modules were outside its scope. Your own procedures and validation are still required.

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.