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AssurX QMS
Reno, Nevada, United States
What it is
AssurX QMS is configurable quality management and regulatory compliance software for organizations in regulated industries. It supports audit, corrective and preventive action (CAPA), calibration, change, complaint, document, risk, supplier quality, training and validation management. Electronic workflows can route tasks through alerts, escalations and approvals. Dashboards, real-time KPIs, trend views and analytical tools help teams review 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 the platform with systems including 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 uses 256-bit encryption for data in transit and at rest. Pricing is paid and available on request.
For and against
For
- Covers audits, CAPA, documents, risks and training.
- Automates workflows with alerts and approvals.
- Available as cloud software or on-premise.
- Open API and web services are offered at no charge.
- Mobile-friendly on iOS and Android.
Against
- Pricing is available only on request.
- On-premise and air-gapped deployment may require organizational setup.
The verdict
AssurX QMS brings multiple quality-management functions, workflow automation and analytics into one platform. Its deployment choices, integrations and listed security measures are relevant considerations; pricing requires contacting AssurX.
Who it suits
It suits organizations in regulated fields such as medical devices, pharmaceuticals, biotech, food, aerospace and manufacturing. Teams needing cloud or on-premise deployment and mobile access may also consider it.
Plans and prices
AssurX Cloud QMS
Managed cloud service · web access · updates, monitoring and security patches handled by AssurX
Read 15 Oct 2026 · assurx.com
Custom AssurX subscription
Cloud or on-premises · concurrent, named or mixed licenses · ongoing support and maintenance generally included
Read 15 Oct 2026 · gartner.com
AssurX QMS
Pricing not stated on the opened maker pages; request a demo
Read 7 Oct 2026 · assurx.com
On the record
- Analytics
- The medical-device QMS provides analytics and reporting intended to identify quality issues across the product lifecycle.assurx.com · read 15 Oct 2026
- API
- AssurX says it offers web services and an open API for integration at no charge.assurx.com · read 7 Oct 2026
- Audit management
- Audit functionality supports templates, planning, scheduling, assignments, findings, recommendations and closure tracking.assurx.com · read 15 Oct 2026
- Browser requirement
- The cloud product is accessed through a web browser rather than a separately installed desktop client.assurx.com · read 15 Oct 2026
- 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.assurx.com · read 15 Oct 2026
- Cloud security controls
- The cloud security brochure describes managed firewalls, separated database servers, restricted ports, continuous monitoring and SSL encryption.assurx.com · read 15 Oct 2026
- Company facts
- LinkedIn lists AssurX as privately held, founded in 1993, headquartered in Reno, Nevada, with 51–200 employees.linkedin.com · read 15 Oct 2026
- Company history
- AssurX says the product was architected in 1998 and launched in March 2000 as CATSWeb.assurx.com · read 15 Oct 2026
- Company legal name
- Crunchbase identifies the legal name as AssurX, Inc.crunchbase.com · read 15 Oct 2026
- Complaint management
- Complaint handling covers processing, triage and closure with dashboards, trend reports, audit trails and electronic signatures.assurx.com · read 15 Oct 2026
- Configurability
- AssurX offers no-code tools for creating workflows and adapting processes without changing underlying code.assurx.com · read 15 Oct 2026
- Copyright and licence
- Public brochures identify AssurX, Inc. as copyright holder and do not present an open-source licence.assurx.com · read 15 Oct 2026
- Core modules
- The platform includes audit, CAPA, complaint, document, training, risk, change, deviation, nonconformance and supplier-quality processes.assurx.com · read 15 Oct 2026
- Deployment
- The same software is offered as SaaS or on-premises, and the vendor says customers can migrate between them.assurx.com · read 15 Oct 2026
- Documentation and support
- The supplier-quality page describes a detailed manual covering basic operations through complex configurations and an embedded AI chatbot.assurx.com · read 15 Oct 2026
- Document control
- Document management provides controlled revisions, approvals, electronic signatures, retention, permissions and audit trails, with links to training and quality events.assurx.com · read 15 Oct 2026
- Encryption
- The maker states that it uses 256-bit encryption for data in transit and at rest.assurx.com · read 7 Oct 2026
- Hosting architecture
- Cloud customers share the application platform but receive dedicated databases, with optional dedicated hardware and bandwidth.assurx.com · read 15 Oct 2026
