Close the Loop Between Quality Events and the Data That Explains Them
Most quality systems track CAPAs and deviations in isolation. Uncountable’s QMS connects every quality event to the formulation, process, and production data that caused it—giving your team the context to fix problems permanently, not just close tickets.
The Anatomy of a Quality Problem That Never Gets Solved
Follow a single deviation through the typical quality system. At every stage, the same pattern repeats: the data exists somewhere, but the system can’t connect it.
The deviation is logged.
A batch fails viscosity spec at your plant. The quality engineer opens the QMS, fills out a deviation form, and classifies it. But the form doesn’t link to the batch record, the formulation revision, or the raw material lot. It’s a ticket, not a trail.
The investigation goes sideways.
To understand what happened, the engineer emails the lab for CoAs, asks R&D if the formulation changed recently, and manually queries the ERP for the supplier lot. Each answer comes from a different system, at a different speed, in a different format.
The CAPA addresses the symptom.
Under time pressure, the team identifies the most likely cause, writes a corrective action, and closes the CAPA. But without cross-referencing other deviations across products and sites, they can’t confirm the root cause. They’re treating the instance, not the pattern.
The same failure shows up again.
Six weeks later, a different product at a different plant hits the same spec failure. The new team opens a new CAPA. No one connects it to the first event because the two deviations live in separate records with no shared context. The cycle repeats.
The audit exposes the gap.
An auditor asks for the full history of a product family’s quality events. Your team spends three days assembling it from spreadsheets, email threads, and two QMS exports. The auditor notes a finding: systemic issues were not identified or addressed.
This isn’t a people problem. It’s a systems problem. Your quality team is disciplined. Your tools just aren’t connected.
What Changes When Quality Data Is Connected
Here’s how quality workflows change when every event is linked to the formulation, process, and production data behind it.
Without Uncountable QMS:
Engineer manually gathers context from 3–4 systems over 1–2 days
With Uncountable QMS:
Platform instantly surfaces the linked formulation, batch, raw material lot, and recent process changes
Without Uncountable QMS:
Root cause analysis relies on institutional knowledge and ad hoc queries
With Uncountable QMS:
AI correlates the event with similar deviations across products, sites, and time—highlighting probable root causes
Without Uncountable QMS:
Trends are caught only during periodic management review, if at all
With Uncountable QMS:
Platform proactively flags recurring failure modes and cross-site correlations in real time
Without Uncountable QMS:
Formulation or process changes are documented in PLM; quality impact is assessed separately, if at all
With Uncountable QMS:
Change control triggers automatic quality risk assessment linked to the product’s full deviation and test history
Without Uncountable QMS:
Team spends days assembling records from multiple systems into a coherent narrative
With Uncountable QMS:
Full traceability—from quality event to formulation decision to production batch—is available in a single query
Built for How Quality Teams Actually Work
Uncountable’s QMS isn’t a bolt-on module or a standalone ticket tracker. It’s a quality management system built directly into the platform where your formulation, testing, and production data already lives.
CAPA Management
Initiate, investigate, assign, and verify corrective and preventive actions through configurable stage-gate workflows. Every CAPA links to the formulation revision, batch record, and test data that triggered it.
Nonconformance & Deviation Tracking
Capture and classify deviations with structured investigation templates. Risk-based escalation rules automatically route critical events to the right stakeholders.
Complaint Management
Log external complaints and tie them directly to production batches, formulations, and raw material lots—so the quality team starts the investigation with context, not questions.
Change Control
Manage formulation, process, and material changes with structured impact assessments, multi-level approvals, and automatic post-change quality monitoring tied to the product’s full history.
Document & SOP Control
Author, review, approve, and distribute controlled documents with full version history. Link SOPs directly to the quality events and processes they govern.
Supplier Quality Management
Track supplier performance against incoming material specs, link supplier lot data to downstream deviations, and manage supplier CAPAs within the same system.
Three Layers of Quality Intelligence
Standalone QMS platforms are databases with workflows. Uncountable’s QMS adds intelligence—because quality improvement requires understanding why failures happen, not just documenting that they did.
Cross-Event Pattern Detection
Find the signal in the noise – Uncountable’s AI scans across all quality events—CAPAs, deviations, complaints, audit findings—to identify patterns that span products, production lines, sites, and time periods. A single out-of-spec result is an incident. The same raw material lot appearing in deviations across three products is a systemic signal.
Predictive Risk Scoring
Act before the next failure – Using historical quality data, formulation changes, and supplier performance trends, the platform scores incoming production batches for quality risk. Flag at-risk runs before they reach final QC. Shift from reactive investigation to proactive prevention.
Why a Connected QMS Changes Everything
Standalone QMS tools require you to build and maintain integrations with your R&D, lab, and production systems. Uncountable’s QMS is natively connected to PLM, LIMS, and R&D data because it’s built on the same platform. Here’s what that means in practice.
Quality ↔ R&D
When a formulation change triggers a downstream deviation, the development team sees it in context. When R&D makes a material substitution, the QMS automatically flags open quality events on the affected product family. No email chains. No blind spots.
Quality ↔ LIMS
QC test results flow directly into quality event investigations. Out-of-spec flags can automatically generate deviations. CoAs, SPC trends, and environmental data are available inside every CAPA—not in a separate system behind a login.
Quality ↔ PLM
Every quality event is linked to the product’s full lifecycle record: formulation revisions, BOMs, scale-up data, and manufacturing specs. Change controls initiated in the QMS update the PLM record. Product and quality histories are one and the same.
Quality ↔ ERP & Instruments
Sync batch records, production schedules, and supplier data with leading ERPs. Pull instrument data directly into quality investigations. Eliminate manual data re-entry and the errors that come with it.
From Audit Scramble to Audit Confidence
Regulatory compliance shouldn’t be a special project. Uncountable’s QMS builds traceability into how your team already works—so the audit trail creates itself.
- Automatic Audit Trails – Every action, approval, escalation, and edit across every quality event is logged with timestamps, user identity, and full context. Nothing to assemble. Nothing to reconstruct.
- Electronic Signatures & Approvals – Configure multi-level approval workflows with electronic signatures that meet FDA 21 CFR Part 11 and EU Annex 11 requirements.
- Controlled Document Management – SOPs, work instructions, and quality policies are versioned, reviewed, approved, and distributed within the same platform. No shared drives. No version confusion.
- Global Harmonization – Standardize quality event workflows, escalation criteria, and reporting across all sites. Allow for site-level customization within a governed global framework.
Built for Every Stakeholder in the Quality Chain
- VP of Quality – Executive dashboards with real-time visibility into open CAPAs, deviation trends, CAPA effectiveness rates, and audit readiness scores across all sites. Management review data is always current—never a quarterly compilation exercise.
- Quality Engineer – Investigation workbenches with every piece of context—formulation history, batch records, raw material data, SPC charts—already linked to the quality event. Spend time analyzing, not assembling.
- Regulatory & Compliance – Audit-ready traceability from any quality event to the underlying product, process, and supplier data. Generate compliance packages in minutes. Maintain confidence between audits, not just during them.
- R&D / Formulation – Visibility into how formulation decisions affect downstream quality. See which material substitutions, process changes, or scale-up adjustments triggered deviations—and use that insight to make better decisions going forward.
- Plant / Operations – Real-time quality dashboards, automated deviation capture from production data, and clear escalation paths that keep the line running while quality events are investigated.
Deploying a QMS in a Regulated Environment
Every Uncountable QMS deployment follows a structured, validation-ready methodology designed for regulated manufacturing. We’ve rolled out quality systems across single-site operations and multi-plant global companies—and every deployment is scoped around your specific compliance requirements, not a generic template.
Map current quality workflows, event types, escalation paths, approval chains, and regulatory requirements. Define what migrates, what changes, and what stays.
Set up quality event types, CAPA stage-gate workflows, approval routing, role-based access, and integrations with your LIMS, PLM, and ERP. Migrate and validate historical quality data.
Run structured test scenarios using real quality events. Confirm workflows, permissions, calculations, and integrations. Your team signs off before go-live.
Operate both systems simultaneously. Your validation team confirms audit trails, electronic signatures, and data integrity meet regulatory requirements before cutover.
Full cutover with embedded support. Direct access to Uncountable’s implementation team for real-time troubleshooting during the first weeks of live operation.
Extend to additional sites, enable AI analytics, refine workflows, and build custom dashboards as your team matures on the platform.
Ready to Connect Quality to the Data That Matters?
