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Quality · eQMSOOS & Lab Incident Investigation

OOS investigation software level by level, signed at every level.

Swat iQua Suite OOS investigation software runs out-of-specification investigations in up to three levels, each with its own review and approval, then locks the finished record. Lab quality events — OOT results, complaints and other lab incidents — follow the same controlled path.

  • Up to three investigation levels
  • Server decides the current level
  • Finalised records are locked
  • One CAPA, approved with the final level
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Real product footage

Watch an OOS investigated level by level.

OOS lifecycle

Every level reviewed — then locked.

Draft → In Review → In Approval → Level Approved, repeated for each required level → Approved (closed) → Finalized (locked).

  1. Level 1Always runs

    Initial investigation

    Level 1 is reviewed and approved for every OOS record.

    Level approved

  2. Level 2When required

    Extended investigation

    Runs when flagged at creation, with its own reviewer and approver.

    In review

  3. Level 3When required

    Further investigation

    A third level where needed — the server, not the user, works out which level is current.

    If flagged

  4. FinalizeLocked

    Approved & finalised

    Finalising locks the record. Controlled print is only possible after this, and each print is logged.

    Finalized

If CAPA is required, one CAPA is raised and approved when the final level is approved.

Key capabilities

Out of specification software that cannot be steered.

  • Levels set at creation

    Level 1, 2 and 3 flags are set when the record is created. The server works out the current level, so nobody can skip one.

  • Level-aware SoD

    Each level’s approver must differ from the creator and from that level’s reviewer, including checks across levels.

  • E-sign on review & approval

    Sites can require a password re-authentication on review and on approval.

  • Finalize and lock

    A Finalize step locks the investigation. Controlled print is available only after finalising and is logged.

  • Lab quality events

    OOS, deviation, complaint-OOT and other lab events with categories, an L1 review and approval, and L2 when required.

  • Linked CAPA

    When CAPA is required, the OOS or lab event raises one CAPA, approved with the final level.

How it works

OOS, OOT and lab incidents — one controlled investigation story.

An OOS result is the moment a QC lab is most closely watched. Swat iQua Suite makes the investigation path explicit: which levels are needed is decided when the record is created, each level has its own reviewer and approver, and the record cannot be edited once it is finalised.

Mapping to your OOS procedure

The three levels give you a structure to follow your own SOP — for example, a laboratory investigation at Level 1 and a full-scale investigation at Level 2 where the lab cannot find an assignable cause. Because the server works out the current level from the flags, the order is always followed and every level’s approval is recorded separately.

Lab quality events and incidents

Not every lab problem is an OOS. Lab quality events record OOS, deviation, complaint or out-of-trend (OOT) events and other incidents, with categories, a Level 1 review and approval, and Level 2 when required. After approval the event produces a controlled PDF report, with a watermarked preview before then. Like OOS, an event can raise one CAPA that is approved when the event is fully approved.

Linked to samples, instruments and release

  • An OOS record can link to the testing sample in Sample & Testing Management or to an instrument maintenance record.
  • In-house QC testing classifies each result as within limits or OOS, so the analyst sees the failure immediately and opens the investigation.
  • Open OOS investigations prevent the related batch release checklist items from being attested.
  • OOS and lab event records are available through the REST API.

OOS records are opened by the lab team. Automatic creation of an OOS record from a flagged in-house QC result is not yet part of the product.

Regulations

Designed to support OOS investigation expectations.

  • US FDA cGMP

    Failures of a batch to meet specifications thoroughly investigated and documented — see 21 CFR 211.192.

    FDA cGMP

  • ALCOA+

    Attributable, contemporaneous investigation records that cannot be altered once finalised.

    ALCOA+

  • MHRA data integrity

    Investigation history kept complete, with every change and reason in the audit trail.

    MHRA data integrity

Keep exploring

Related

FAQ

Frequently asked questions

Can’t find your answer? Talk to our team — we reply within one business day.

What is OOS investigation software?

Software that manages the investigation of out-of-specification test results in a controlled, documented workflow. Swat iQua Suite runs up to three investigation levels, each with its own review and approval, and locks the record once finalised.

Can we follow a Phase I / Phase II OOS procedure?

Yes. Level 1 always runs and Levels 2 and 3 run when required, so you can map them to the phases in your own SOP. The server enforces the order of levels.

Does it handle OOT results and lab incidents?

Yes. Lab quality events cover OOS, deviation, complaint-OOT and other events, with categories, Level 1 review and approval and Level 2 when required.

Can an OOS record be changed after it is closed?

No. Finalising the investigation locks it. Controlled print is only available after finalising, and every print is logged.

Is an OOS record created automatically from a failing result?

Not at present. In-house QC testing flags results as OOS, and the lab then opens the investigation, linked to the sample.

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