Close the Loop Between
Quality Events and Root Cause.
Uncountable's QMS connects every CAPA, deviation, and complaint to the formulation, batch, and process data behind it — built for the compliance demands of chemicals, materials, food & beverage, and medical devices, so your quality team starts every investigation with context, not questions.
See how Uncountable connects quality to the data that explains it.
Quality events get closed. Root causes don't get fixed.
Most quality systems track CAPAs and deviations as tickets. They don't connect them to the formulation, batch, or supplier data that caused them. So investigations stall, patterns go undetected, and the same failures repeat — in different products, at different sites.
Every investigation starts from scratch
When a deviation is filed, the quality engineer emails R&D for formulation history, asks the lab for CoAs, and manually queries the ERP for supplier lots. Each answer comes from a different system, in a different format, at a different speed.
CAPAs address symptoms, not causes
Under time pressure, teams close CAPAs based on the most likely cause — not a confirmed one. Without cross-referencing similar deviations across products and sites, patterns stay invisible. The same failure returns six weeks later.
Audit prep is a multi-day fire drill
Auditors ask for traceability from a quality event back to the formulation decision and production batch. Your team spends days assembling records from email threads, PDF exports, and two QMS systems with no shared context.
Quality and R&D operate in separate worlds
When R&D makes a material substitution or process change, QC doesn't automatically see the quality risk. When a formulation change triggers a downstream deviation, development doesn't see the pattern. The gap costs time and product quality.
Quality connected to the data that explains every failure.
Uncountable's QMS isn't a standalone ticket tracker. It's built directly into the platform where your formulation, testing, and production data already lives — so every quality event is investigated with full context from the start.
CAPA & Deviation Management
Initiate, investigate, assign, and verify corrective actions through configurable stage-gate workflows — every CAPA linked to the batch record, formulation revision, and test data that triggered it.
AI-Driven Root Cause Analysis
Uncountable's AI scans across all quality events — CAPAs, deviations, complaints, audit findings — to surface patterns spanning products, production lines, sites, and time. A single result is an incident; a pattern is a systemic signal.
Audit-Ready Traceability, Built In
Every action, approval, and edit across every quality event is logged with timestamps, user identity, and full context — automatically. Generate compliance packages in minutes, not days. Meet FDA 21 CFR Part 11 and EU Annex 11 requirements.
Change Control & Supplier Quality
Manage formulation, process, and material changes with structured impact assessments and multi-level approvals. Track supplier performance against incoming material specs, and link supplier lot data directly to downstream deviations.
Predictive Risk Scoring
Using historical quality data, formulation changes, and supplier performance trends, the platform scores incoming production batches for quality risk — so you flag at-risk runs before they reach final QC.
Cross-Site Quality Governance
Standardize quality event workflows, escalation criteria, and reporting across all sites. Allow for site-level customization within a governed global framework — with real-time executive dashboards across all locations.
Results from teams like yours
150+ Enterprise product teams worldwide
Chemicals, materials, food & beverage, medical devices & life sciences, and more
Built for every stakeholder in the quality chain
VPs of Quality get real-time dashboards across all sites. Quality engineers start investigations with every piece of context already linked. Regulatory teams generate compliance packages in minutes, not days.
Natively connected to R&D, LIMS & PLM
No integration tax. Uncountable's QMS is built on the same platform as your formulation, testing, and lifecycle data — so every quality event is automatically linked to the context that explains it.
Want to link quality to the data that uncovers every issue?
