---
title: Quality Management System | Uncountable
description: Uncountable's QMS auto-links every CAPA, deviation, complaint, and audit, cutting audit prep from days to hours. Connect it to our native LIMS or your ERP.
image: https://get.uncountable.com/hubfs/qms.png
---
[QMS Modules](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#modules) [How it works](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#wedge) [AI Capabilities](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#proactive) [Integrations](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#integrations) [Why Uncountable](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#differentiators)
[Request a Demo](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#demo)
Connected QMS | Built for Regulated Manufacturers
# Everything your quality team is accountable for, in one connected system
Uncountable's QMS runs deviations, CAPAs, complaints, change control, documents, training, and audits as one connected system, so every record links to the others automatically instead of getting rebuilt by hand across spreadsheets and email.
[Request a Demo](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#demo) [See what's included](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#modules)
Quality Management · Live Oversight Live
OPEN CAPAS4
OVERDUE TRAININGS2
FINDINGS RESOLVED78%
Quality Events by Severity
Low
Medium
High
Critical
| Record | Type | Status |
| --- | --- | --- |
| FND-00007 | Audit Finding | Open |
| ASG-000003 | Training | Overdue |
| CAPA-0192 | CAPA | Initiated |
**Bodie AI:** Correlated 3 open findings to CAPA-019212 min ago
Illustrative UI: not actual customer data
Powering quality data for regulated, formulation-driven manufacturers
                                                                
                                                                
Common challenges
## Managing quality events in spreadsheets, not a system?
QC tells you what passed, not what happens next, or how you prove to a regulator you're in control. So teams fill that gap with spreadsheets and email, not by choice, but because they've outgrown what they started with.
### Root cause analysis starts with a scavenger hunt
Investigating a deviation means manually gathering context from three or four systems before the actual analysis can even start.
### Deviations and CAPAs are text forms, not data
Institutional knowledge and ad hoc queries stand in for a documented investigation, so CAPAs stall for weeks and the same failure modes keep recurring.
### Supplier qualification runs through email
Registration, forms, and material submissions get buried in threads instead of living on a governed record the whole team can see.
### Audit prep takes days, not hours
Teams spend days assembling records from multiple systems into a coherent narrative for every internal, customer, or regulatory audit.
[See how Uncountable solves this →](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#demo)
Uncountable's QMS Modules
## Quality Management System Modules
Modules aren't silos: a finding can spawn a CAPA, a CAPA a change, a change training. Unlike legacy QMS platforms, workflows stay configurable as your processes evolve, not locked in place after go-live.
### Audit Management
Faster audits, fewer repeat findings, always inspection-ready.
- Reusable checklists for internal, supplier, and regulatory audits.
- Findings escalate into a CAPA automatically when needed.
- A clean, walkable trail for the next auditor.
### Complaint Management (Portal)
Fewer missed deadlines and a professional self-service experience.
- A branded portal to submit and track complaints, no email needed.
- A structured workflow ending in a documented root cause.
- Automatic due-date tracking for reportability decisions.
### Supplier Management (Portal)
Fewer disruptions, defensible records, less email back-and-forth.
- One record per supplier: status, criticality, agreements.
- Qualification scoped to the material, not just the company.
- SCARs with response tracking and effectiveness checks.
### Training Management
Audit-ready training records on demand, no spreadsheet scrambling.
- Curricula built from reusable modules, by role or department.
- Assignments trigger automatically from hires or CAPAs.
- Certification records with expiry tracking.
### CAPA Management
One place to investigate root cause and prove the fix worked.
- Audits, complaints, and events feed one structured CAPA intake.
- Root cause methodology built into the workflow.
- Effectiveness verification required before closure.
### Document Management
One source of truth, so everyone works off the approved version.
- Full version history with an approval trail.
- A revision can trigger retraining automatically.
- Periodic review scheduling so nothing goes stale.
- Edit documents in-platform, no export-and-reupload cycle.
### Change Management
Prevents SOPs, training, and qualifications from falling out of sync.
- Approval paths scale with the classification of the change.
- Ties together every affected document, asset, and training.
- Multi-stage e-signature approval with a defensible trail.
### Equipment Management
Keep every asset calibrated and qualified before it's ever audited.
- Calibration and maintenance schedules with due-date tracking.
- Formal IQ/OQ/PQ history kept separate from maintenance.
- Direct links to the SOPs and training tied to each asset.
### Quality Event Management (NCRs, Deviations, Incidents)
Contain issues fast and keep a clean record of every disposition.
- One consistent intake for nonconformances and incidents.
- Containment and disposition captured up front.
- Escalates automatically into a CAPA or SCAR.
### Risk Management
Ties every decision to a documented, standards-based risk assessment.
- FMEA, risk matrix, or HACCP, standardized across your org.
- Every hazard scored before and after mitigation.
- Feeds directly into supplier tiers and CAPA priority.
### Batch Release Management
Release decisions backed by every record that touches the batch.
- Automatic hold when an open deviation, CAPA, or change touches the batch.
- Certificate of Analysis and disposition generated from linked records.
- Multi-stage e-signature release, with the full chain of custody attached.
### Management Review
Turn quality trends into a documented review, not a recurring meeting.
- Auto-populated KPI packet: open CAPAs, audit findings, complaint trends.
- Review actions become tracked follow-ups, not notes in a slide deck.
- Full history of past reviews and actions, ready for the next audit.
[See the modules in action](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#demo)
How it works
## What being connected actually delivers
One record behind every quality event, audit, configuration change, and portal interaction, so nothing needs to be reconciled by hand. Pick a capability to see it in practice.
Linked events
Audit trail
Configurability
Customer portal
### Every quality event links to everything it touches
Every quality event links to the complaints, SCARs, findings, and changes connected to it, so investigations start with a full picture, not a search.
- Every CAPA links back to the quality event, complaint, or audit finding that triggered it
- Root cause analysis becomes a query, not a manual search across three or four systems
- Risk-based escalation rules automatically route critical events to the right stakeholders
NCR-0468: Investigation
| Related Record | Status |
| --- | --- |
| Customer Complaint CMP-0091 | Investigating |
| SCAR-0117 (Supplier) | Open |
| CAPA-0468 | In Progress |
| Change Request CR-0217 | Pending Approval |
Every related record surfaced automatically when the investigation opens
Click on image to enlarge
Illustrative UI: a quality event investigation in Uncountable
### From audit scramble to audit confidence
Every action, approval, escalation, and edit is logged automatically, so the audit trail builds itself instead of getting assembled before an audit.
- Automatic audit trails capture every action with timestamps, user identity, and full context
- Electronic signatures and multi-level approvals meet FDA 21 CFR Part 11 and EU Annex 11 requirements
- Standardize quality workflows and escalation criteria across every site, with room for site-level customization
Audit Package: Q3 Internal Audit (ISO 9001)
| Clause / Section | Status |
| --- | --- |
| Clause 8.5 – Production & Service Provision | Conformant |
| Clause 8.7 – Nonconforming Outputs | 1 Minor NC |
| Clause 9.2 – Internal Audit Program | Conformant |
| Clause 10.2 – CAPA Effectiveness Evidence | Linked to CAPA-0451 |
| Auditor Sign-off | e-Signed |
Full traceability from clause to finding to CAPA, generated in minutes
Click on image to enlarge
Illustrative UI: an ISO 9001 internal audit package in Uncountable
### A system that's configured to fit you, not the other way around
Most QMS platforms lock in workflows at go-live, and changing them means a costly services engagement. Uncountable stays configurable as your team's processes mature.
- Reconfigure workflows, forms, and approval routing yourself, without a paid services engagement for every change
- Add new quality event types, fields, and escalation logic as your processes grow more sophisticated
- One platform that scales from a single site's first CAPA process to a multi-site enterprise program
Workflow Configuration: CAPA Approval Path
| Step | Editable |
| --- | --- |
| Intake & Classification | Configurable |
| Root Cause Method (5-Why) | Configurable |
| Approval Routing (Site QA Lead) | Configurable |
| Effectiveness Check Trigger | Configurable |
Adjusted in-app by your admin, no vendor ticket required
Click on image to enlarge
Illustrative UI: reconfiguring a workflow without vendor services
### One portal for everyone outside your quality system
Uncountable's portal gives customers and suppliers a branded, permissioned front door into your records, no login or email required. Field-level permissions control visibility.
- Customers and suppliers report issues, respond to SCARs, and submit documents without email back-and-forth
- Field-level permissions split what's portal-visible from internal-only, record by record
- Every external interaction stays inside the same system as the rest of your quality record
Complaint Intake #94Customer Portal
SubmittedIn ProgressClosed
CompanyTruly Foods
Complaint TypeProduct Quality
Lot NameLOT-AB1
Expiration DateJul 2, 2026
Status & Resolution
StatusResolved / Closed
ResolutionIngredient ratio corrected; re-shipment issued.
Submitted, tracked, and resolved without a single email to your quality team
Click on image to enlarge
Illustrative UI: the branded portal a customer sees
Ready to see it live on your own data?[Get your live demo](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#demo)
Before and after
## What changes when quality data is connected
Quality failures start as small signals, a familiar finding, a slipping supplier, an unchecked change. Without a connected system, those signals surface only after they've become a problem.
| When… | Without a connected QMS | With Uncountable QMS |
| --- | --- | --- |
| A deviation is filed | An engineer manually gathers context from three or four systems over one to two days | The platform instantly surfaces every related finding, CAPA, SCAR, and change request tied to the same product, process, or supplier |
| A CAPA is investigated | Root cause analysis relies on institutional knowledge and ad hoc queries | AI correlates the event with similar CAPAs, findings, and SCARs across sites and time |
| A pattern emerges | Trends are caught only during periodic management review, if at all | The platform proactively flags recurring failure modes and cross-site correlations in real time |
| A change is made | Quality impact is assessed after the fact, separately from the documents and training it affects | Change control triggers a structured risk assessment and automatically flags every document, training assignment, and piece of equipment it affects |
| An auditor asks a question | The team spends days assembling records from multiple systems into a coherent narrative | Full traceability, from finding to disposition, is available in a single query |
| A new supplier is onboarded | Qualification forms, certificates, and approval status get tracked across spreadsheets and email threads with the supplier | A governed supplier record tracks criticality tier, qualification documents, and approval status, with the supplier submitting directly through the portal |
[Get these results for your team](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#demo)
Proactive by design
## Proactive and predictive quality, not reactive firefighting
Modern quality teams can't wait for the next audit to catch a problem. Connecting every module to the same records is what makes analytics and AI surface drift and repeat failures before they become the next one.
### Leading-indicator dashboards
Open CAPAs, trends, and aging investigations surface automatically, so the team knows where to act first.
### One data layer, every source
Every module shares one data layer, so the platform learns from history instead of starting fresh each time.
### AI-assisted analysis
Connected records speed up correlation and pattern discovery, turning root cause work into a decision, not a search.
### Preventative controls
Governed workflows catch mistakes at the point of capture, so teams don't inherit preventable messes.
### Traceability & permissions
Every action stays attributable and audit-ready, giving stakeholders visibility without losing control.
[See these outcomes on your own data](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#demo)
Integrations & Connections
## Deploy standalone, a natively-integrated suite, 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.
R&D / ELN Systems
LIMS Systems
PLM Systems
MES
ERP
Lab Instruments
[See how it fits your stack](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#demo)
Why teams choose Uncountable
## 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.
### Dynamic policy enforcement at the point of work
Training certifications, equipment qualifications, and supplier requirements are enforced the moment work happens, not tracked down after the fact.
Enforced automatically because every module reads the same records. No integration required.
### One connected QMS, not a stack of point tools
CAPA, change control, audits, documents, suppliers, training, and complaints run on one connected system, referencing shared records instead of duplicating them.
Replace several point systems with one, without losing a single module.
### Three layers of quality intelligence, not just tracking
Correlation links a finding to its CAPA instantly, pattern detection surfaces repeat sources, and risk scoring flags the next likely nonconformance.
AI applied to structured quality data, not a bolt-on chatbot tool.
[See the difference yourself](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#demo)
Is this the right fit?
## Built for regulated, data-driven quality teams
A connected QMS is for teams ready to run every quality module as one system: here's how to tell if it's the right fit, and where to go if it's not.
### Good fit
- You manage CAPAs, deviations, complaints, or change control in spreadsheets, paper, or email
- Root cause analysis relies on institutional knowledge instead of connected data
- Audits mean days spent assembling records from multiple systems
- Quality, operations, and suppliers need one shared source of truth
### Looking for more than a QMS?
- You need a bundled solution: one platform connecting R&D, Quality, Product Lifecycle, and Project Management, not a single module bolted onto the rest
- You're evaluating point solutions like LIMS, ELN, PLM, or PPM, and want a system that scales into all of them instead of adding another silo
- You want one source of truth connecting Uncountable's natively-built products with your QMS, not a separate system to keep in sync
- Your external systems (ERP, SAP, etc.) don't offer seamless bi-directional data flow into one live source of truth
[Explore Uncountable's full platform](https://get.uncountable.com/uncountable-unified-platform-overview?hsLang=en)
### Common industries using a connected QMS
Specialty Chemicals & Materials Industrial Manufacturing Food & Ingredient Manufacturing Aerospace & Defense Life Sciences & GxP Pharmaceuticals Personal Care & Cosmetics Coatings & Adhesives
Request a demo
## See your quality data connected, live, in one system
See a live walkthrough of the full QMS: how a finding turns into a CAPA and a change, and how it fits into your existing systems.
- See a nonconformance instantly surface every related finding, CAPA, and SCAR
- If you use LIMS or PLM, connect them too (entirely optional)
- Walk through a CAPA from filing to closed, with effectiveness evidence attached
- Ask how Uncountable compares to a document-centric legacy QMS
One connected system for every product, spec, and change, for process and discrete manufacturers alike.
#### Product
- [Uncountable Platform](https://get.uncountable.com/uncountable-unified-platform-overview?hsLang=en#products)
- [Laboratory Information Management System (LIMS)](https://get.uncountable.com/enterprise-lims-laboratory-information-management-system-software?hsLang=en)
- [Electronic Laboratory Notebook (ELN)](https://get.uncountable.com/connected-eln-electronic-laboratory-notebook?hsLang=en)
- [Product Lifecycle Management (PLM)](https://get.uncountable.com/enterprise-plm-product-lifecycle-management-software?hsLang=en)
- [Project Portfolio Management (PPM)](https://get.uncountable.com/connected-ppm-project-portfolio-management-software?hsLang=en)
- [Quality Management System (QMS)](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers)
#### Company
- [About](https://www.uncountable.com/company)
- [Customers](https://www.uncountable.com/customers)
- [Careers](https://www.uncountable.com/careers)
- [Contact Us](https://www.uncountable.com/contact-us)
#### Resources
- [Blog](https://www.uncountable.com/blog)
- [Guides](https://www.uncountable.com/solution-guides)
- [Case Studies](https://www.uncountable.com/case-studies)
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