---
title: Quality Management System | Uncountable
description: "Uncountable's QMS runs deviations, CAPAs, complaints, change control, documents, training, and audits as one connected system: standalone, and even better connected to your existing LIMS, ERP, or PLM."
image: https://get.uncountable.com/hubfs/uncountable-qms-featured-image.png
---
[QMS Capabilities](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) [Why Uncountable](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#differentiators) [Integrations](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#integrations) [FAQ](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#faq)
[Request a Demo](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#demo)
Connected QMS Software | For Regulated Manufacturers
# QMS software that holds everything your quality team is accountable for
Uncountable's quality management system software connects deviations, CAPAs, change control and documents in one eQMS, so nothing gets rebuilt by hand.
Request a demo
## See your quality data connected, live, in one system
Get a live walkthrough of our full QMS and how it fits into your existing systems.
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
Powering quality data for regulated, formulation-driven manufacturers
                                                                
                                                                
Top 3 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 is a scavenger hunt
Investigating a deviation means manually gathering context from three or four systems before the actual analysis can even start.
### 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 customer or regulatory audit.
[See how Uncountable solves this →](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#demo)
Uncountable's QMS Capabilities
## Quality Management System Solutions & Capabilities
Every capability is connected: 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
Submit complaints directly through the self-service portal.
- Seamlessly track complaints to reduce missed deadlines.
- A structured workflow ending in a documented root cause.
- Automatic due-date tracking for reportability decisions.
### Supplier Management
Our supplier portal feeds vendor data into one system of record.
- 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 spreadsheets.
- 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
Collaborate with 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
Prevent SOPs, training, and qualifications from misaligning.
- 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
Contain issues fast and keep a clean record of every disposition.
- One consistent intake for NCRs, deviations, and incidents.
- Containment and disposition captured up front.
- Escalates automatically into a CAPA or SCAR.
### Risk Management
Tie every decision to a documented 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 vs. 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 |
All related records surfaced 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 10.2 – CAPA Effectiveness Evidence | Linked to CAPA-0451 |
| Auditor Sign-off | e-Signed |
Full traceability from clause to finding to CAPA, 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
Click on image to enlarge
Illustrative UI: the branded portal a customer sees
[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)
Integrations
## Seamlessly integrate any of your existing external systems with our products & platform.
Use any Uncountable product on its own, as a native suite, or integrate your existing and external tools so your quality data lands in one system of record, not a silo.
LIMS
PLM Systems
MES
SCM Systems
ERP/SAP
CRM
3PL Systems
LMS
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 eQMS, 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, equipment, and supplier rules are enforced as work happens, not after.
### One connected QMS, not a stack of point tools
Every module runs on one system, sharing records instead of duplicating them.
### Three layers of quality intelligence, not just tracking
AI links findings to CAPAs, spots repeat sources, and flags the next likely nonconformance.
[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.
### A few signs of a 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
- You work under FDA, ISO, or EU GMP requirements and need credible audit trails and e-signatures
[Demo Uncountable's QMS](https://get.uncountable.com/connected-qms-software-for-regulated-manufacturers#demo)
### Looking for more than a QMS?
- You need one platform that connects R&D, Quality, Product Lifecycle, and Project Management, not a single module bolted onto the rest
- You're evaluating point solutions like LIMS, ELNs, & PLMs that are scalable, not a siloed system
- You want one source of truth connecting Uncountable's QMS to its other native products
- 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
Common questions
## QMS software questions, answered
Straight answers on what QMS software is, what it should include, and how it relates to the LIMS in your lab.
What is QMS software?
QMS software is the system a regulated manufacturer uses to run and document its quality processes: deviations, CAPAs, complaints, change control, document control, training, supplier quality, and audits. It replaces spreadsheets, shared drives, and email threads with structured, linked records, so every action has an owner, a timestamp, and an audit trail.
The goal is to show an auditor, and your own team, that quality is under control and that problems get fixed for good, not just closed out.
What's the difference between a QMS and an eQMS?
A QMS is the full set of processes, responsibilities, and records an organization uses to manage quality, and it can live on paper. An eQMS is that same system run electronically, with controlled workflows, electronic signatures, and automatic audit trails that support expectations like FDA 21 CFR Part 11 and EU Annex 11.
In practice, most teams shopping for QMS software are shopping for an eQMS. The difference that matters more today is whether the modules are connected: whether a deviation, its CAPA, the resulting change, and the retraining it triggers live in one record or in separate tools.
What should QMS software for manufacturing include?
At a minimum, look for audit management, quality events (NCRs, deviations, and incidents), CAPA, change control, document control, training management, and supplier and complaint management. Equipment management, risk management, batch release, and management review round out a full system.
Beyond the modules, check that workflows are configurable without a services engagement, that every action is logged automatically, that customers and suppliers can participate through a portal, and that the system connects to your LIMS, ERP, PLM, or MES instead of becoming another silo.
How much does QMS software cost?
It depends on your needs. Pricing is shaped by which modules you want to start with, how many teams and sites will use the system, how much configuration and integration your processes require, and whether you bundle QMS with other Uncountable products such as LIMS, ELN, or PLM.
Many teams start with the modules that cause the most friction today and add more over time. The most reliable way to get a clear picture is to request a demo, so we can scope it around your processes.
How is a QMS different from a LIMS for Quality (AKA QC LIMS)?
A QC LIMS (also called a LIMS for QC) manages the testing itself: samples, methods, specifications, results, and sample disposition in the lab. A QMS manages the quality system around that testing: what happens when a result is out of specification, how it is investigated, which CAPA and change follow, who gets retrained, and how it is all documented for an audit.
Put simply, the LIMS answers "what did we measure?" and the QMS answers "what did we do about it, and can we prove it?" They work best connected, so an out-of-spec result can open a deviation that is already linked to the batch and samples behind it. Uncountable offers both on one platform, and the QMS can also connect to the LIMS you already use.
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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