A deviation is only as useful as the context recorded with it. In Swat iQua Suite many deviations are raised by the system at the point where a limit was broken, so the batch, step, room or sample is already linked when QA opens the record.
Where deviations come from
- Manual entry by any authorised user, with department, impact category and classification.
- Batch execution — an out-of-limit critical process parameter reading in the electronic batch record raises a deviation.
- Sterile operations — an EM action excursion, a failed sterilisation cycle, filter integrity test or media fill drives the sterile-impact process.
- Utilities monitoring — an action-limit breach on WFI, clean steam, compressed air or HVAC.
- Laboratory raw data review — a finding from second-person review raises a deviation automatically.
Decision, actions and closure
After approval, a separate decision-taker chooses whether to proceed. A Proceed decision opens the actions, each with an owner, a due date and a verifier. Extensions can only push a date forward, and the system refuses to verify an overdue action that has no approved extension — so the action history an inspector reads is the history that actually happened.
When the investigation itself is complete but long-running actions remain, QA can interim-close the deviation with an e-signed justification. The record shows as Closed (open actions) until every action is finished and the deviation is finally closed.
Connected to the rest of the quality system
A deviation can raise a CAPA in CAPA Management, approved in the same step as the deviation. Open deviations also matter at release: the batch release checklist cannot be attested while linked deviation, OOS or CAPA records still block it. Every write — and every reason for it — goes to the same audit trail used across the platform.