What does ISO 13485 require and how does V5 cover it?

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.

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.