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Invariant enforces one quality-event lifecycle server-side, so records cannot be short-circuited to a falsely “closed” state.

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Enforced gates (not conventions)

  • A deviation cannot close without a documented RCA conclusion + a linked disposition.
  • CAPA effectiveness cannot be signed before all actions are complete.
  • A CAPA cannot close before effectiveness is verified.
  • Maker-checker: the author/requester/owner cannot approve, close, or reopen their own record.
  • Reason for change is required on every mutation of a previously recorded regulated value.
  • Every controlled transition writes an atomic, hash-chained audit entry in the same transaction.
These gates are the difference between a system that records quality work and one that enforces it.