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AssurX

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Configurable enterprise quality and regulatory compliance management software.

Corrective And Preventive Action Software Quality Management Software
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  • Deployment Cloud Based, On Premises
  • Starting price Custom
  • Free trial Not offered
  • Best for SMEs, Enterprises

What is AssurX?

AssurX is a configurable enterprise quality management and regulatory compliance platform for regulated industries such as life sciences, medical devices, and semiconductors. It provides pre-configured workflows out of the box for CAPA, complaints management, deviations, change management, audits, risk management, supplier quality, and document management, reducing reliance on paper-based or disconnected systems.

The platform supports 21 CFR Part 820, ISO 13485, ISO 9001, and similar standards, with an audit trail and electronic signature capability built to exceed 21 CFR Part 11 requirements. AssurX is available as either a cloud-based SaaS solution or an on-premise, platform-agnostic deployment. Pricing is not published; it depends on users, modules, and deployment type, and requires contacting sales.

Key Features of AssurX

AssurX lists 10 documented features, including CAPA management, Complaints management and Deviation tracking. The list below covers what the product does rather than how it is marketed.

  • CAPA management
  • Complaints management
  • Deviation tracking
  • Change management
  • Audit management
  • Risk management
  • Supplier quality management
  • Document management
  • Training management
  • 21 CFR Part 11 compliant audit trail and e-signatures

AssurX Pricing

AssurX lists 1 plan without published figures. Pricing is quoted on request.

Custom

Custom

Priced by users, modules, and deployment type

Request pricing

Subscription-based pricing for cloud or on-premise deployment; contact sales for a quote.

AssurX Specifications

AssurX is available on web app. It offers an API.

Deployment
  • Cloud Based
  • On Premises
Billing cycle
Yearly
Desktop
  • Web App
Languages
  • English
Built for
  • SMEs
  • Enterprises
Support
  • Email
  • Phone
  • Training
  • Tickets
Integrations
ERP and other enterprise business systems
Public API
Yes
Free trial
No
Free plan
No
Runs in browser
Yes
Customisable
Yes
Website
assurx.com

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AssurX FAQs

AssurX is available both as a cloud-based (SaaS) solution and as an on-premise, platform-agnostic deployment.

AssurX supports compliance with 21 CFR Part 820, ISO 13485, ISO 9001, and similar quality and regulatory standards.

No, AssurX does not publish pricing; costs depend on users, modules, and deployment type and require contacting sales.

It includes CAPA, complaints, deviations, change management, audits, risk management, supplier quality, and document management as pre-configured workflows.

Yes, its audit trail and e-signature capabilities are built to meet 21 CFR Part 11 requirements.