Catch the Bad Batch Before It Ships
Uncountable's QC LIMS runs quality control at production scale: live SPC, out-of-spec alerts, and deviation and CAPA management, all connected to the formulation and full instrument data behind every result.
Deployed by enterprise R&D and innovation teams:
By the Time the Monthly Report Runs, the Batch Has Shipped
In most plants, quality control data lands in a LIMS as a single pass or fail number, and the control charts are rebuilt by hand in Minitab or JMP once a month. Drift is invisible until it becomes a failure, an out-of-spec result kicks off an email chain to reconstruct what happened, and the formulation and instrument context that would explain it lives in another system. Uncountable's QC LIMS charts every result live as it is entered, flags an out-of-spec point the moment it appears, and opens the deviation with the batch, formulation, and full instrument data already attached.
Quality Control, From the Result to the Release
Catch drift while you can still act on it. Live SPC charts every result as it is entered, so an out-of-spec point shows up in real time.
Live SPC, not a monthly export
Control charts update as results are entered, so a trend is visible in real time instead of after the batch has shipped.
Real-time OOS and control-rule alerts
Out-of-spec points and control-rule violations fire the moment they appear, not at the next Minitab review.
Capability at a glance
Process capability (Cpk) is tracked continuously against your configurable specifications.
An out-of-spec result should open with the evidence already attached, not an email chain.
Deviation with the data linked
The batch record, formulation revision, raw-material lots, and full test data are attached automatically the moment a result is out of spec.
Root cause traces to the recipe
Every result carries the formulation and process that produced it, so the why is one click away instead of stopping at a number.
Deviation opened, CAPA handed to QMS
The out-of-spec result opens a deviation with the evidence linked; corrective action and change control run in the QMS governance layer on the same record.
Release the batch with a clean, traceable record, not a document hunt.
Certificates of analysis
Generated from the QC results, with specifications and measured values in one place instead of a hand-built PDF.
E-signatures and approvals
Batch release is captured with electronic signatures and a full audit trail of who released what and when.
Traceable end to end
Release decisions trace back to the formulation and raw-material lots behind the batch, so disposition stands on evidence.
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Stay compliant and connected across every site, on one platform:
21 CFR Part 11 & EU Annex 11
Automatic audit trails and electronic signatures for regulated batch release.
QMS
An out-of-spec result can auto-generate a deviation, and CAPAs carry the CoAs and SPC behind them.
Integrated ELN & LIMS
The R&D record and sample data every QC result traces back to.
Product Lifecycle Management (PLM)
Specifications and approved formulations flow from development into QC.
Multi-site dashboards
First-pass yield, out-of-spec rate, open deviations, and Cpk by line, across sites.
Guided rollout
Specifications and control rules configured in during a staged implementation, including instrument and ERP integration.
Before and After Uncountable
Without Uncountable
With Uncountable
What Our Customers Say
Engineering Manager, Mitra Chem
Runs quality control on Uncountable across five labs and more than a thousand users, handling 300+ batches per day with bidirectional SAP integration.
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One tells you what happened. The other tells you why.
A QC result is what happened. The formulation, process, and full instrument data behind it are why. When both live on one model, quality control stops being a number and becomes a traceable answer. Structure first, AI second.
FAQs
Uncountable QC LIMS is the quality-control capability of the Uncountable platform, part of the Quality suite, built for production scale. It handles sample login, test plans, and results capture against configurable specifications, with live SPC, real-time out-of-spec alerts, and deviation and CAPA management, all connected to the formulation and full instrument data behind every result.
The R&D LIMS is built for experimentation: capturing formulations, full instrument data, and search across past work. QC LIMS is built for quality control at production scale: specifications, live SPC, out-of-spec handling, deviation and CAPA, batch release, and certificates of analysis. They share one data model, so every QC result traces straight back to the R&D record that produced it.
Yes. Statistical process control runs live as results are entered, so the technician sees the control chart update on the same screen, rather than exporting to Minitab or JMP for an after-the-fact review. Out-of-spec points and control-rule violations trigger alerts in real time, and process capability (Cpk) is tracked continuously.
An out-of-spec result can automatically open a deviation with the batch record, formulation revision, raw-material lots, and full test data already linked. Root cause, CAPA, and disposition are handled in the same system, so the investigation starts with the evidence in hand instead of an email chain.
Yes. Uncountable supports automatic audit trails and electronic signatures meeting FDA 21 CFR Part 11 and EU Annex 11, with role-based access and versioned records, so batch release and audit preparation are backed by a complete, traceable record.
