PlatformOOS and OOT investigations

OOS investigation software with two enforced phases

When a result falls outside specification, your lab knows exactly what happens next, and so does anyone who reviews it later. QMSdesk™ OOS investigation software runs every out-of-specification result through a Phase 1 laboratory investigation and a signed Phase 1 review before anything else can happen.

Bring one workflow. See it running.Explore every feature

OOS investigation

OOS-004

Dissolution result out of specification, batch DT-2026-15

Phase 1 laboratory

Workflow

Step 2 of 6: Phase 1 laboratory investigation

Phase 1 deadline: 1 business day, GMP profile
Lab-error checks: Calculation, sample, instrument, reagent, method
Phase 2: Opens only after the signed Phase 1 review

Confidence in every result you report

The expected path, every time

Phase 1 in the lab, a signed review, then Phase 2 if there's no assignable lab error. Nobody has to remember the order, because the workflow holds it.

Invalidations that stand up

When Phase 1 finds an assignable lab error, the invalidation is a signed decision, with its reasoning on the record for anyone who reviews it later.

Patterns you'd otherwise miss

Every invalidated result counts toward lab-error trends by method, analyst and instrument, so a recurring cause surfaces from your own records.

How an out-of-specification investigation runs, Phase 1 to Phase 2

Step 1 of 6
Reported
The test method, the result and the specification limit it missed.
Step 2 of 6
Phase 1 laboratory investigation
The analyst records the findings, whether a lab error was found, and the instrument used.
Step 3 of 6
Signed step
Phase 1 review
A reviewer decides: invalidate the result for an assignable lab error, or proceed. An invalidation closes the record here, with the signed decision as its basis.
Step 4 of 6
Phase 2 investigation
The full investigation, with the root cause and the batches affected.
Step 5 of 6
Signed step
QA review
QA confirms the OOS, invalidates it or records it as unresolved, and decides whether a recall and a CAPA are needed.
Step 6 of 6
Signed step
Closed
The final conclusion is recorded and the closure-record PDF is ready.

The structure follows FDA's guidance on investigating OOS results. Under the GMP profile, the Phase 1 deadline is one business day.

OOS investigation software built to hold up

You can't reclassify your way around it

OOS/OOT has its own locked workflow, never the generic one. Steps can't be removed, and there's no route to Phase 2 or to closure that skips the signed Phase 1 review.

Lab-error trending, where the CAPA belongs

A CAPA decision on every invalidated result would be out of proportion. Instead, invalidations are trended, and a recurring lab error is where the CAPA belongs. QMSdesk makes that trend visible by method, analyst and instrument.

A CAPA decision that counts

At QA review, a "CAPA required" decision raises the linked CAPA in the same transaction as the signature, with its own change control and training.

Feature index

Everything in OOS/OOT

The investigation

Reported, then Phase 1 lab investigation, then Phase 1 review, then Phase 2 investigation, then QA review, then Closed
Test method, result and specification limit captured at report
Phase 1 records findings, lab error found or not, analyst and instrument
Signed Phase 1 review: invalidate for assignable lab error, or proceed
Phase 2 with root cause and batches affected
Signed QA review: confirm, invalidate or unresolved, with recall and CAPA decisions
Signed closure with a final conclusion
A locked workflow that can't be reclassified around

Added by regulatory profiles

GMP: a one-business-day Phase 1 deadline

Controls on every OOS record

Linked CAPA raised in the same transaction as the signed decision
Cancelled with a signed reason, never deleted
Deadlines that escalate but never block, with delay reasons
Configurable numbering, never reissued
Closure-record PDF with the full signature manifest, and every download logged
My Work and the review queue
Recorded in the SHA-256 hash-chained audit trail

One connected system

Connected across QMSdesk

OOS/OOT is one of the quality events QMSdesk handles, alongside deviations.

A "CAPA required" decision at QA review raises the CAPA.

Lab-error and event trends sit in reporting and analytics.

Regulations

Regulations it's designed to support

21 CFR 211.192 (investigation of discrepancies) and EU GMP, under the GMP profile, with Annex 11 record controls
FDA's guidance on investigating OOS results, whose two-phase structure the workflow follows
ICH Q10, for the CAPA that follows a confirmed OOS
21 CFR Part 11 for every signed decision

Questions buyers ask

Can an analyst skip Phase 1?

No. Every OOS or OOT result goes through the Phase 1 laboratory investigation and a signed Phase 1 review before Phase 2 or closure. The steps are locked, and administrators can't remove them.

What happens when Phase 1 finds a lab error?

The reviewer signs an invalidation, and the record closes on that signed decision. The invalidation counts toward lab-error trends by method, analyst and instrument, so recurring errors surface.

Does QMSdesk handle OOT results?

Yes. OOT results use the same OOS/OOT workflow and appear in the same event trending.

Does a confirmed OOS raise a CAPA automatically?

QA decides, and signs. When QA records that a CAPA is required, the linked CAPA is raised in the same transaction.

Every result, investigated the way it should be

Bring an OOS investigation from your lab, and we'll run it through QMSdesk with you.