AI LIMS software for labs where a wrong result is a recall.
V5 Ultimate runs the full QC loop — sample on the kiosk, result on the chart, OOS into investigation, investigation into CAPA, signed CoA to the customer portal — and puts AI where the lab loses time: structuring the OOS, reading inbound CoAs and specs, spotting the trend before it becomes an excursion, and assembling stability and verification reviews from real data.
You're looking at AI in the lab because the science is fine and the paperwork is the bottleneck.
An OOS investigation is a Word template, a memory and a week
Supplier CoAs are PDFs that an analyst retypes into the receiving inspection record
Trends are only visible when someone exports results into a spreadsheet
Stability time-points and annual verification reviews are assembled by hand
The lab is the last to know a process has drifted, because nobody is watching between batches
Barr-ruling traps — averaging, retesting into compliance — depend on analysts remembering the rules
Where AI helps a regulated lab without touching the result.
OOS investigation, structured and drafted
An out-of-spec result quarantines the sample and opens a structured investigation bound to the run, instrument, reagent lot, analyst and method revision. AI drafts the phase-one narrative and surfaces prior occurrences on the same method, instrument or lot.
CoA and specification intake
Inbound CoAs and supplier specs are extracted layout-agnostically, matched to the open PO or lot, and compared against your spec server-side. The original PDF is retained and linked to every extracted value.
Trend and CPV analysis
Results are trended continuously against control limits, with drift and shift called out before the excursion — and rolled into continued process verification rather than discovered at annual review.
Stability study support
Time-point pulls, protocols and results assembled into the study picture, with trends and shelf-life implications summarised for the reviewer to challenge.
Rules the model cannot bend
Retest rules are enforced server-side. Averaging traps are blocked by design. AI cannot produce, alter or approve a result — it structures and explains the ones your instruments and analysts produced.
CoA built from real values
The released lot's Certificate of Analysis is generated from actual results, signed under §11.50 and delivered to the customer portal with every view logged.
What the lab gets back.
- OOS phase-one work starts from a drafted, evidence-linked investigation instead of a blank template
- Receiving inspection stops waiting on someone retyping a supplier CoA
- Drift is visible between batches, not at annual review
- Every result carries its instrument, calibration status, reagent lot, method revision and analyst
- Customer CoAs go out signed, from live data, with the delivery logged
What a regulated lab is measured against.
21 CFR 211.160–211.194
Laboratory controls, testing and release, stability, and complete records for every test — evidenced from live execution rather than reconstructed.
FDA OOS guidance and the Barr ruling
Structured phase-one / phase-two investigation, enforced retest rules, and no averaging away of a failing result.
ISO/IEC 17025
Method, equipment, competence and traceability of measurement captured with each result, with signed disposition and documented review.
ICH Q2(R2) / ICH Q14
Analytical procedure validation and lifecycle evidence held against the method revision actually used to produce each result.
21 CFR Part 11 / Annex 11
Signed results and dispositions, append-only audit trail, and AI outputs that remain drafts until an authorised analyst signs.
AI in the lab, answered.
What is an AI LIMS?
A laboratory information management system with a model layer that structures and drafts the work around the result — the OOS investigation, the inbound CoA, the trend, the stability picture — while measurement, disposition and signature remain the analyst's. It does not generate, adjust or approve results.
Can AI decide whether a result is out of specification?
No. The specification comparison is a deterministic server-side check against the method and spec revision in force. AI helps with what happens next: structuring the investigation and surfacing what has failed the same way before.
Does it replace our instruments' software?
No. Instrument readings are captured against the sample with instrument ID, calibration status and operator signature. V5 is the record and the workflow around the instrument, not a replacement for it.
Is the lab a separate product from the QMS and MES?
No — one platform, one data model. An OOS opens a deviation, the deviation spawns a CAPA, the batch is held and the disposition routed, without an integration between systems.
Does it support ISO/IEC 17025 as well as GMP?
Yes. Method, equipment, competence and measurement traceability are first-class, so labs running to 17025 and to 21 CFR 211 use the same system.
Is our lab data used for model training?
No. Inference runs inside your tenant; results, methods and investigations are not training data.
Run a sample, fail it, and watch the investigation build itself.
Free trial. No sales gate. The whole QC loop on one record.