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 enterprise R&D and innovation teams:
A Standalone QMS Records the Event. It Cannot Explain It.
Most quality systems are document engines bolted on beside the lab. They capture that a deviation happened and route a CAPA for signatures, but the formulation revision, batch record, raw-material lots, and test data that explain the event live in other systems. So every investigation starts by reassembling the evidence by hand. Uncountable's QMS is built into the same platform as R&D and QC, so a quality event opens with its full lineage already attached, and the corrective action can change the specification directly.
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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.
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.
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.
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.
Explore the QMS Modules
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 every controlled document and SOP current, versioned, and tied to the work it governs.
Versioned document and SOP control
Controlled documents are authored from templates, versioned, and routed for review and approval, with approved content locked against unrecorded changes.
Change stays connected
An SOP change can trigger the associated retraining, so document control and competency never drift apart.
Always audit-ready
Every action is timestamped and attributed, so the current version and its full history are one click away.
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.
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Without Uncountable
With Uncountable
Why Connected Quality Management Pays Off
The cost of a quality system is not the software, it is the time lost reassembling evidence for every investigation and every audit. When each quality event already carries the formulation, batch, and test data behind it, investigations are faster, corrective actions actually reach the specification, and audits become a report instead of a fire drill.
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Downloads
Description
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. Structure first, AI second.
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.
A standalone eQMS records that an event happened and routes documents for signatures, but the data that explains the event lives in other systems. Uncountable's QMS shares one model with R&D and QC, so a quality event opens with its full lineage attached and a corrective action can update the specification directly.
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.
