Catch drift before it becomes a failure
Uncountable's LIMS for Quality runs quality control at production scale: live SPC, out-of-spec alerts, and deviation management with a direct handoff to QMS, all connected to the formulation and full instrument data behind every result.
Deployed by 175+ enterprise product development teams
Deployed by Enterprise R&D and Innovation Teams
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 LIMS for Quality 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.
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.
Automate the workflow around every result
Test reviews, CAPAs, and non-conformances don't have to live in a spreadsheet someone remembers to update. Configure the process once, and the system routes the work, assigns it, and tells people when it's waiting on them.
Workflow automation
Task & notification management
Reduce administrative overhead
Before and after Uncountable
The old way
The Uncountable way
Platform capabilities
One LIMS, five labs, 300+ batches a day
Lubrizol runs Uncountable's LIMS for Quality across 5 labs and 1000+ users, testing more than 300 batches each day, with bidirectional integration with SAP.
5 labs
1,000+ users
300+ batches a day
A phased rollout, not a flip of a switch
Going live on a new LIMS is staged, not a single cutover weekend. Each phase is scoped around your specs, your instruments, and your team, with the existing system still running until the new one has proven itself.
Connects to the systems you already run
Uncountable's LIMS for Quality integrated bidirectionally with SAP and 400+ instrument types, and connects natively to LIMS for R&D, ELN, PLM, MES, Project Management and QMS, so quality data never lives in a silo.
What changes with one connected record
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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.
FAQs
Uncountable LIMS for Quality 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.
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.
Could you produce a batch's full test history right now?
