AssurX
by AssurX, Inc. · Healthcare & Life Sciences
Configurable enterprise QMS and compliance platform for life sciences and medical devices.
Updated August 2026 · By the ERP Research Editorial Team · Independent and vendor-neutral.
- Works with
SAP
Oracle- Deployment
- Cloud, On-premise
- Company size
- Mid-market, Enterprise
- Pricing
- Quote-based
- Founded
- 1993
- Headquarters
- Morgan Hill, California, United States
Overview
AssurX is a configurable enterprise quality management system (eQMS) and regulatory compliance platform aimed at pharmaceutical, biotech, medical device, and other regulated manufacturers. The company was originally founded as Intuitive Data Solutions in 1993 and incorporated as AssurX in California in 2000.
The platform closes the loop across quality processes: complaint handling, CAPA (corrective and preventive action), deviation management, nonconformance, change control, audit management, document control, training management, supplier quality, and risk management. Records originating in one process, such as a customer complaint or an audit finding, can trigger and connect to CAPA, training, and document-control workflows rather than living in separate systems.
AssurX is delivered as a cloud-based SaaS platform with an architecture the company describes as combining a multi-tenant front end with customer-dedicated back-end databases, and it is also offered on-premise. It publishes an open API and documents integration experience with enterprise systems including SAP, Oracle, Salesforce, PTC/Windchill (PLM), and MES platforms, positioning the QMS as a hub that connects to ERP, PLM, MES, LIMS, and CRM systems already in place at a customer.
Screenshots & demo
Demo video from the vendor's YouTube channel.
Modules & capabilities
AssurX covers 23 of 54 capabilities we track in this category (+1 partial)
43%- Document version control & approval workflowsVersion control and audit trailsSupported
- Electronic signaturesElectronic signatures on document approval and training completionSupported
- Training linked to document changesAutomatic training assignment on document release; training also triggered from CAPA/deviation/change-controlCore strength
- Training records & competency trackingJob-title and department-based training requirementsSupported
- SOP authoring & controlGeneral document control; no dedicated SOP module namedPartial
- Collaborative document authoringCollaborative authoring, review and approval routingSupported
- Role-based document access controlConfigurable, role-based dashboards across record typesSupported
“Not evidenced” means our research found no public documentation of this capability — the vendor may still offer it. Confirm on a demo.
Common use cases
- Centralizing complaint handling and regulatory reportability decisions for a medical device manufacturer
- Running CAPA investigations that trace back to the audit finding, complaint or deviation that triggered them
- Automating document approval routing and tying document release directly to employee training assignments
- Managing supplier quality issues and corrective action requests across a multi-site supply chain
- Standardizing audit scheduling, checklists and finding tracking across internal and supplier audits
- Configuring role-specific dashboards so quality, regulatory and operations staff see only relevant tasks
- Connecting quality records to ERP, PLM or MES systems such as SAP, Oracle or PTC Windchill via open API
Strengths & considerations
Strengths
- Highly configurable workflow engine that lets customers model complaint, CAPA, audit, deviation and change processes without custom code
- Closed-loop data model connecting complaints, CAPA, audits, deviations, training and document control as linked records rather than silos
- Documented integration experience with SAP, Oracle, Salesforce and PTC/Windchill alongside an open API for ERP/PLM/MES/LIMS/CRM connectivity
- Available as both cloud SaaS and on-premise deployment
Used AssurX with your ERP? Rate it in 30 seconds — it helps every buyer after you.
Rate itERP integrations
AssurX documents integration experience connecting its QMS to SAP via API/custom integration; no productized connector or marketplace listing found.
AssurX documents integration experience connecting its QMS to Oracle via API/custom integration; no productized connector or marketplace listing found.
Connector details independently verified against vendor marketplaces and documentation; last checked 2026-08-20.
Pricing
Full AssurX pricing breakdown — cost at 25/100/500 seats, competitor rates & FAQs
AssurX does not publish list pricing; cost is quoted based on modules selected, user count and deployment model. Get an independent shortlist with pricing guidance below.
What does AssurX cost?
AssurX prices by quote, like most of this category. Here is what actually drives your number — and what to ask before you get one.
9 of the 12 vendors we track in this category publish no list price at all.
Technical & security
- Hosting
- SaaS (multi-tenant front end with customer-dedicated back-end databases) or on-premise
- Mobile app
- Yes
About the vendor
- Founded
- 1993
- Headquarters
- Morgan Hill, California, United States
- Employees
- 51-200
- Ownership
- Private
Alternatives to AssurX in Healthcare & Life Sciences
AssurX — frequently asked questions
What quality processes does AssurX cover?
AssurX covers complaint handling, CAPA, deviation management, nonconformance, change control, audit management, document control, training management, supplier quality and risk management as linked records in one platform.
Does AssurX integrate with ERP systems?
AssurX publishes an open API and documents integration experience connecting its QMS to enterprise systems including SAP, Oracle, Salesforce and PTC/Windchill, alongside ERP, PLM, MES, LIMS and CRM platforms generally.
Is AssurX cloud-based or on-premise?
AssurX is offered both as cloud-based SaaS and as an on-premise deployment. Its cloud architecture combines a multi-tenant front end with customer-dedicated back-end databases.
What industries use AssurX?
AssurX is used primarily by regulated manufacturers such as pharmaceutical, biotech and medical device companies, as well as food and beverage, energy and utilities, and high-tech manufacturing organizations.
How is AssurX priced?
AssurX pricing is quote-based; the company does not publish list prices, and cost depends on the modules selected, number of users and deployment model.
Compare AssurX head-to-head
The Healthcare & Life Sciences Buyer's Guide
Before you commit to AssurX, see how it sits against the 12 healthcare & life sciences systems we track — on capability, ERP integration depth and what each one actually charges for.
Healthcare & Life Sciences Buyer's Guide
12 systems compared · 2026
ERP Research
- AssurX compared side-by-side with 11 alternatives
- ERP integration checklist — what to verify before you shortlist
- The pricing questions that change the quote
- A AssurX evaluation brief, included with the guide
Healthcare & Life Sciences Buyer's Guide
Get pricing for AssurX
AssurX doesn't publish a price. Tell us your ERP, seat count and must-haves and we'll come back with an independent view of what it should cost you — and which alternatives are worth quoting alongside it.