Close the loop between quality events and the data that explains them
Uncountable's QMS runs CAPA, deviations, complaints, and change control in one system, with every quality event linked to the formulation revision, batch record, raw-material lots, and test data behind it. Built in, not bolted on.
Deployed by 175+ enterprise product development teams
Deployed by Enterprise R&D and Innovation Teams
What is a connected QMS?
A quality management system, or QMS, helps organizations manage controlled quality processes:
A connected QMS goes further. It links each quality event to the product, formulation, raw-material, test, batch, specification, and change-history data required to investigate the issue and prevent it from happening again.
Uncountable brings quality management into the same data foundation as R&D, laboratory operations, product lifecycle management, and manufacturing. Quality teams can move from finding a deviation to understanding the evidence behind it without rebuilding the story across disconnected systems.
Quality evidence shouldn't live somewhere else
Many quality systems are separate from labs, requiring manual evidence gathering for deviations. Uncountable's QMS integrates directly with formulation and test data, providing immediate context for quality events and enabling direct specification changes.
QMS across one connected platform
Every quality event opens with its full lineage attached, not a blank form and a reconstruction.
Deviations, nonconformances, complaints: Capture every event type in one system, with an out-of-spec QC result able to auto-generate a deviation on the spot.
The evidence is already linked: Each event links to the formulation revision, batch record, raw-material lots, and test data behind it, so the investigation starts with the facts in hand.
Nothing captured in isolation: Because it is one model with R&D and QC, an event is connected to its cause from the moment it is logged.
Containment and disposition captured up front: The containment action and the product disposition are logged the moment the event is opened, not reconstructed later for the investigation report.
The CAPA executes the spec change. One action, one system, zero handoffs between quality and R&D.
Stage-gate CAPA: Corrective and preventive actions run through a configurable stage-gate workflow, each linked to the triggering formulation revision, batch, and test data.
Correct at the source: Because quality and R&D share one model, a corrective action can update the specification and product record directly, not end in a document someone else has to action.
Root cause on evidence: The full history behind the event is one click away, so the correction addresses the cause rather than the symptom.
Predictive risk scoring: Quality events are scored for risk as they're logged, so the CAPAs most likely to escalate surface first.
Control what changes, and keep every version and approval on the record.
Change control with impact assessment: Changes route through impact assessments and multi-level approvals, so nothing changes without the right review.
Document and SOP control: Versioned document and SOP control keeps controlled documents current, with an SOP change able to trigger retraining.
Supplier quality: Raw-material lots and supplier records are tied to the events they cause, so supplier issues are traceable, not anecdotal.
Classification-driven approval paths: Administrative changes move through a lighter path; major changes get full multi-level scrutiny, so the review matches the risk instead of one approval chain for everything.
Prove it to any auditor, across every site, on one connected platform.
Audit trails & e-signatures: Automatic, meeting FDA 21 CFR Part 11 and EU Annex 11, so audit prep is a report, not a scramble.
Training & competency: An SOP change triggers retraining, tracked to completion, so competency stays current.
Global harmonization: One quality system across sites, with governed site-level customization.
Connected to R&D, QC & PLM: The formulation, test data, and product record behind every event, on one model.
Dashboards & reports: Open-CAPA aging, deviations by source, overdue actions, and audit readiness across sites.
Guided rollout: Your deviation, CAPA, and change-control processes configured in during a staged implementation.
Your approval routing, your escalation rules, your field labels, configured to match how your organization already runs quality, not the other way around.
Admin-configured, not hardcoded: Stage-gate steps, approval routing, and escalation rules are set by your quality admins in the platform, not built into the code, so the workflow matches your SOPs from day one and changes when they do.
Governed customization, not chaos: Each site can tailor forms, fields, and routing to local requirements, while a shared global process keeps everything auditable and comparable across sites.
Configured in, not bolted on: Your deviation, CAPA, and change-control processes are configured during a guided, staged implementation, so the system reflects how your team already works before go-live.
From quality event to closed-loop improvement
When a deviation, complaint, out-of-specification result, or production issue occurs, quality teams need more than a case record. They need to understand what changed and what evidence supports the next decision. With Uncountable, teams can connect a quality event to the relevant data across the product lifecycle.
Explore the QMS capabilities
When a quality complaint comes in, teams need more than a shared inbox. They need a clear path from intake to resolution.
Structured intake: Complaints are captured in a structured form through Uncountable's customer-facing portal, so the right details arrive from the start and flow straight into the platform.
One connected workflow: Triage, severity, investigation, customer communication, and responsibility determination are tracked in a single workflow, not spread across email and spreadsheets.
End-to-end visibility: Quality teams follow each case from the original complaint through follow-up, approvals, and final closure, with the record intact for audit.
Keep competency current as procedures change, without a separate training system to reconcile.
Role-based assignment: Training and competency are tracked and assigned by role, so the right people are qualified for the work they do.
Triggered by change: When an SOP changes, the associated retraining is triggered and tracked to completion, so nothing falls through the cracks.
On the same record: Training records sit in the same system as the documents and quality events they relate to, ready for inspection.
Plan, schedule, and run quality audits on the same platform that holds the evidence.
Build and schedule from templates: Create reusable audit templates, such as an ISO 9001 audit, and schedule them, so audit programs run on a cadence rather than ad hoc.
Findings stay linked: Audit findings connect to the events, documents, and records they relate to, so follow-up actions are traceable to their source.
Audit readiness across sites: Automatic audit trails and one connected system make preparation a report rather than a scramble.
What changes when quality is built in
The old way
The Uncountable way
One quality system, every module together
Built as one connected system, not ten disconnected tools
Every module runs on the same record, the same permissions, and the same rules. No stitching point solutions together or reconciling data by hand.
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Deploy standalone or integrate with your existing systems
Every Uncountable product can be deployed on its own, combined for a fully native suite, or connected with your existing R&D, LIMS, PLM, MES, or ERP systems and lab instruments. So quality events and change data flow into the same record instead of a new silo.
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The CAPA executes the spec change.
When quality events and the data that explains them live on one model, a corrective action reaches the specification directly, and the loop between quality and R&D finally closes. One action, one system, zero handoffs.
FAQs
Uncountable QMS is the quality management capability of the Uncountable platform, part of the Quality suite. It runs CAPA, nonconformance and deviation tracking, complaint management, change control, and document and SOP control, with every quality event linked to the formulation revision, batch record, raw-material lots, and test data behind it. It is built into the platform, not a bolt-on.
CAPA management with a stage-gate workflow, nonconformance and deviation tracking, complaint management, change control with impact assessments and multi-level approvals, document and SOP control, supplier quality management, and training and competency tracking, all with audit trails and e-signatures.
Yes. QMS supports global harmonization with governed site-level customization, so every site runs the same quality processes while still accommodating local requirements, under one auditable system.
Yes. An out-of-spec result in QC can automatically open a deviation, and certificates of analysis and SPC data sit inside the CAPA. QMS connects to R&D, LIMS, PLM, ERP, and 400+ lab instruments, so quality events and their evidence stay linked end to end.
Bring your CAPA.
We'll show you the difference.
