ISO 13485:2016 is the international QMS standard for medical devices. It requires controlled documents, training records, design controls, CAPA, supplier controls and risk management. V5 enforces these in execution — operators are blocked from steps they aren't trained for, change control routes through approval, and records are immutable.
Yes. V5 enforces Part 11 in code: identity-verified e-signatures on every gated step, immutable audit trail with hash-chained record versions, role-based access controls, and PDF renderings of every batch record signed under the same identity bound to the action.
Yes. V5 ships with the Annex 11 controls EU inspectors look for: validated computerised system, risk-based change control, periodic review, incident management, and a full audit trail. Validation artefacts (URS, FS, IQ/OQ/PQ templates) are included for Validated Enterprise tier customers.
FSMA Section 204 is the FDA Food Traceability Rule, fully enforced January 2026. It requires Key Data Elements at every Critical Tracking Event for foods on the Food Traceability List. V5 captures CTEs at receive, transform, ship and reconciles lot codes back to the sortable spreadsheet the FDA can request within 24 hours.
