US cGMP expects any unexplained discrepancy or out-of-specification result to be thoroughly investigated (21 CFR 211.192), and every major regulator expects the same discipline. In Swat iQua Suite, an OOS investigation runs in up to three levels. Level 1 always runs; Levels 2 and 3 are flagged when required at creation, and the server works out the current level — so nobody can skip ahead.
Each level has its own review and approval, and the approver can be neither the creator nor that level’s reviewer. A Finalize step locks the record, and controlled print is only possible after finalising. When a CAPA is required, it is raised from the investigation and approved together with the final level.
Lab quality events — OOT trends, lab incidents and complaints — follow a similar staged review with optional CAPA, so every lab investigation sits in one place.
Results that cannot be quietly rewritten
Specification versions are frozen when a sample is registered, and the specification is locked while samples are open. Results lock once submitted; a reviewer can send them back to result entry, and in in-house QC a correction adds a new observation with a reason and e-signature while the original is kept.
In-house QC flags each result as within limits or OOS. Opening the OOS investigation is a deliberate step by the lab, not an automatic one.
