Document control

Document control is the backbone process every regulated quality system stands on. 21 CFR 211.180/211.194, 21 CFR 820.40 and ISO 13485 §4.2.4 all require that documents be approved by authorised personnel before issue, that the current version be available at point of use, that obsolete versions be removed, and that change history be retained for the document's lifetime.

In V5 a single `documents` table backs internal SOPs, work instructions, forms, supplier-facing documents and operator training acknowledgements. Kiosk task entry is hard-gated against unacknowledged required docs on the current effective version — an operator cannot start a step until they've signed off on the SOP that governs it.