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AssurX QMS

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Spec score 8.5 #5 of 51 in Compliance Management Software

What it is

AssurX QMS is configurable quality management and regulatory compliance software for organizations in regulated environments. It automates electronic workflows that can include tasks, alerts, escalations and approvals. Listed functions cover audit, CAPA, calibration, change, complaint, document, risk, supplier quality, training and validation management. Dashboards, real-time KPIs, trending and analytical tools support review of quality activity. The software can be deployed as cloud software or on-premise, including in air-gapped environments, and is described as mobile-friendly on iOS and Android. AssurX offers web services and an open API for integration at no charge. The maker lists experience connecting with ERP, PLM, MES, LIMS, CRM, CMMS, SAP, Salesforce, Oracle and PTC/Windchill. AssurX states that it is ISO/IEC 27001:2022 certified and SOC 2 compliant, and that it encrypts data in transit and at rest with 256-bit encryption. Technical support is available to designated customer contacts by phone, fax or email, with same-day responses during regional business hours. Pricing is on request.

Spec sheet

What it does
AssurX is an enterprise quality-management and regulatory-compliance platform for regulated organizations.Read 15 Oct 2026 · getapp.com
Purpose
AssurX is configurable quality management and regulatory compliance software for organizations in regulated environments.Read 7 Oct 2026 · assurx.com
Deployment
The same software is offered as SaaS or on-premises, and the vendor says customers can migrate between them.Read 15 Oct 2026 · assurx.com
API
AssurX says it offers web services and an open API for integration at no charge.Read 7 Oct 2026 · assurx.com
Integrations
The vendor says its open API supports CRM, ERP, LIMS and MES integrations, naming Salesforce, Tableau, SAP, Power BI and ServiceNow.Read 15 Oct 2026 · assurx.com
Security
AssurX states that it is ISO/IEC 27001:2022 certified and SOC 2 compliant.Read 7 Oct 2026 · assurx.com
Support
Technical support is available to designated customer contacts by phone, fax, or email, with same-day responses during regional business hours.Read 7 Oct 2026 · assurx.com
Headquarters
Reno, Nevada, United StatesRead 28 Sep 2026 · assurx.com
Founded
The company says its founders incorporated AssurX in California in March 2000.Read 7 Oct 2026 · assurx.com
Analytics
The medical-device QMS provides analytics and reporting intended to identify quality issues across the product lifecycle.Read 15 Oct 2026 · assurx.com
Audit management
Audit functionality supports templates, planning, scheduling, assignments, findings, recommendations and closure tracking.Read 15 Oct 2026 · assurx.com
Browser requirement
The cloud product is accessed through a web browser rather than a separately installed desktop client.Read 15 Oct 2026 · assurx.com
CAPA workflows
CAPA records can originate from audits, deviations, complaints, nonconformances, incidents and risk assessments, with configurable root-cause methods such as fishbone and 5 Whys.Read 15 Oct 2026 · assurx.com
Cloud security controls
The cloud security brochure describes managed firewalls, separated database servers, restricted ports, continuous monitoring and SSL encryption.Read 15 Oct 2026 · assurx.com
Company facts
LinkedIn lists AssurX as privately held, founded in 1993, headquartered in Reno, Nevada, with 51–200 employees.Read 15 Oct 2026 · linkedin.com
Company history
AssurX says the product was architected in 1998 and launched in March 2000 as CATSWeb.Read 15 Oct 2026 · assurx.com
Company legal name
Crunchbase identifies the legal name as AssurX, Inc.Read 15 Oct 2026 · crunchbase.com
Complaint management
Complaint handling covers processing, triage and closure with dashboards, trend reports, audit trails and electronic signatures.Read 15 Oct 2026 · assurx.com
Configurability
AssurX offers no-code tools for creating workflows and adapting processes without changing underlying code.Read 15 Oct 2026 · assurx.com
Copyright and licence
Public brochures identify AssurX, Inc. as copyright holder and do not present an open-source licence.Read 15 Oct 2026 · assurx.com
Core modules
The platform includes audit, CAPA, complaint, document, training, risk, change, deviation, nonconformance and supplier-quality processes.Read 15 Oct 2026 · assurx.com
Document control
Document management provides controlled revisions, approvals, electronic signatures, retention, permissions and audit trails, with links to training and quality events.Read 15 Oct 2026 · assurx.com
Documentation and support
The supplier-quality page describes a detailed manual covering basic operations through complex configurations and an embedded AI chatbot.Read 15 Oct 2026 · assurx.com
Encryption
The maker states that it uses 256-bit encryption for data in transit and at rest.Read 7 Oct 2026 · assurx.com
Hosting architecture
Cloud customers share the application platform but receive dedicated databases, with optional dedicated hardware and bandwidth.Read 15 Oct 2026 · assurx.com
Independent market assessment
An independent 2026 review describes AssurX as a low-code EQMS best suited to mid-sized and large regulated organizations rather than simple out-of-the-box deployments.Read 15 Oct 2026 · ehsreviews.com
Integration formats
A vendor brochure lists API, web services, XML and file-based connectors for exchanging data with enterprise systems.Read 15 Oct 2026 · assurx.com
Limit: documentation and administration
Capterra reviewers say configuration documentation is light and administrator training or consulting can be necessary.Read 15 Oct 2026 · getapp.com
Limit: navigation and interface
Reviewers report dated or confusing interfaces, difficult navigation and too many clicks for some tasks.Read 15 Oct 2026 · g2.com
Limit: pricing
Reviewers report that pricing becomes less attractive as user licenses increase, while public list pricing is unavailable.Read 15 Oct 2026 · capterra.com
Limit: reporting and stability
G2 reviewers mention limited reporting flexibility, random errors, timeouts and occasional instability.Read 15 Oct 2026 · g2.com
Medical-device reporting
AssurX supports electronic medical-device adverse-event reporting to regulators including FDA, EMA and Health Canada.Read 15 Oct 2026 · assurx.com
Mobile access
AssurX QMS is described as iOS and Android mobile-friendly.Read 7 Oct 2026 · assurx.com
Notable news: 2026 customer advisory board
The vendor says its Customer Advisory Board had 93 individuals from 59 companies across 13 industries.Read 15 Oct 2026 · assurx.com
Praise: configurability
G2 and Capterra reviewers repeatedly praise the ability to tailor workflows and processes to organizational requirements.Read 15 Oct 2026 · g2.com
Praise: support
Reviewers commonly describe AssurX support and implementation specialists as responsive, helpful and technically strong.Read 15 Oct 2026 · capterra.com
Privacy compliance
The vendor states compliance with HIPAA and GDPR and describes permission controls for electronic protected health information.Read 15 Oct 2026 · assurx.com
QMS functions
Listed functions include audit, CAPA, calibration, change, complaint, document, risk, supplier quality, training, and validation management.Read 7 Oct 2026 · assurx.com
Rating on Capterra
4.6 out of 5 from 25 reviewsRead 15 Oct 2026 · capterra.com
Rating on G2
4.7 out of 5 from 14 reviewsRead 15 Oct 2026 · g2.com
Rating on Gartner Peer Insights
4.7 out of 5 from 60 reviewsRead 15 Oct 2026 · gartner.com
Rating on GetApp
4.6 out of 5 from 25 reviewsRead 15 Oct 2026 · getapp.com
Rating on Software Advice
4.6 out of 5; the page reports 64% five-star, 28% four-star and 8% three-star ratingsRead 15 Oct 2026 · softwareadvice.com
Security certification
AssurX states that it is ISO/IEC 27001:2022 certified and SOC 2 compliant.Read 15 Oct 2026 · assurx.com
Supplier quality
Supplier quality workflows include periodic supplier audits, offline remote-audit capture, attachments and signatures.Read 15 Oct 2026 · assurx.com
Who it serves
AssurX identifies medical device, pharmaceutical, biotech, food, cosmetics, electronics, aerospace, government, energy, and manufacturing organizations among the industries it serves.Read 7 Oct 2026 · assurx.com
Workflows
The platform automates electronic workflows that can include tasks, alerts, escalations, and approvals.Read 7 Oct 2026 · assurx.com

Plans and prices

AssurX Cloud QMS Price not published Annual pay-as-you-go fee Managed cloud service · web access · updates, monitoring and security patches handled by AssurX Read 15 Oct 2026 · assurx.com
AssurX QMS Priced on request Pricing not stated on the opened maker pages; request a demo Read 7 Oct 2026 · assurx.com
Custom AssurX subscription Priced on request Quote-based; varies by users, modules, deployment and services Cloud or on-premises · concurrent, named or mixed licenses · ongoing support and maintenance generally included Read 15 Oct 2026 · gartner.com

Every AssurX QMS plan and price →

Strong points and limits

Strong points

  • Workflows can include tasks, escalations and approvals.
  • Deployment can be on-premise or cloud.
  • Air-gapped deployments are available.
  • Open API and web services are offered at no charge.
  • Same-day support responses during regional business hours.

Limits

  • Pricing is available on request.
  • Support is limited to designated customer contacts.
  • Same-day responses are specified for regional business hours.

Who it suits

AssurX QMS suits organizations in regulated industries that need configurable quality workflows and compliance functions. Its cloud, on-premise and air-gapped deployment options may suit teams with different infrastructure requirements.

Verdict

AssurX QMS combines broad quality-management functions with configurable workflows and multiple deployment options. Buyers will need to request pricing and confirm that the desired deployment and support arrangements fit their organization.

Where Specifiction places it

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