In many plants CAPAs live in a spreadsheet that nobody fully trusts: actions are copied from investigation reports, due dates drift and the link back to the original deviation is a reference number typed by hand. Swat iQua Suite removes the copying. The CAPA is created from the source record itself, so the deviation, OOS, audit observation or lab event and its CAPA stay linked for good.
Source-driven approval
When a CAPA is raised from a source record, its approval moves with that record. Approving a deviation approves its CAPA in the same step; approving the final level of an OOS investigation approves the CAPA raised from it. The CAPA hub refuses to approve a source-raised CAPA by itself, so the investigation and the corrective action can never be approved by different chains.
Work the CAPA from inside the source record
The full CAPA work panel — verify actions, request extensions, close and record effectiveness — is also available inside each source record. A QA reviewer looking at a deviation can see and work its CAPA without leaving the page.
Where CAPAs come from
- Deviation Management — a CAPA raised from the deviation and approved with it.
- OOS & Lab Incident Investigation — one CAPA per OOS or lab quality event when CAPA is required.
- Audit Management — internal, external and supplier audits, one CAPA per observation.
- Stability Study Management — escalation for a failure or out-of-trend result.
- Audit Trail Review — a finding from a periodic audit trail review raises a CAPA.
Change control is deliberately not a CAPA source: a change’s corrective mechanism is its own set of verified change actions. Open CAPAs also count at batch release — the release checklist cannot be attested while linked deviation, OOS or CAPA records still block it.
Keeping the register honest
Every change to a CAPA is written to the audit trail in the same transaction, with a mandatory reason. A read-only integrity check scans the register for rule violations, so QA can show an inspector that the controls hold across every record, not only the ones they open.