AssurX
AssurX is a privately held, web-native enterprise quality management and regulatory compliance software vendor serving pharmaceutical, medical device, energy/utilities, and manufacturing buyers with pre-validated EQMS and NERC compliance modules delivered via cloud SaaS or on-premises.
- Company typePrivate
- Founded2000
- HeadquartersReno, United States
- Headcount51–100
- GTM typeB2B
- OfferingSoftware
What AssurX does
AssurX is a private enterprise software company that sells a unified, web-native quality management and regulatory compliance platform to organizations in highly regulated industries. The platform, originally architected in 1998 and formally incorporated in 2000, is delivered from a single codebase that supports both multi-tenant cloud SaaS (hosted at Switch Tier 5 data centers with 99.99% uptime) and on-premises deployments with identical functionality. The portfolio centers on the Enterprise Quality Management Software (EQMS) suite covering CAPA, document, training, supplier quality, complaint, change, risk, audit, calibration, deviation, nonconformance, design control, EHS, quality management review, validation, and patch compliance modules, alongside specialized ECOS (Energy Compliance Operating System) for NERC-regulated utilities and eMDR/EU MDR modules for medical device manufacturers. The platform is pre-validated against FDA 21 CFR Part 11, EU Annex 11, ISO 13485, ISO 9001, NERC CIP, HIPAA, GDPR, and SOC 2 Type 2 / ISO 27001 controls, materially reducing customer time-to-value in validated environments.
AssurX monetizes through SaaS subscriptions, on-premises licenses (perpetual or annual), and a meaningful professional services and software-validation services overlay covering implementation, integration, data migration, training, and technical support. The go-to-market is enterprise field sales plus inside sales targeting pharmaceutical, biotech, medical device, energy/utilities, manufacturing, high tech/electronics, food & beverage, and oil & gas buyers, supported by an SI/reseller partner network (Sikich, BBA, FoxGuard, ICF, Launch Consulting, BPM, TE3), industry events (annual AssurX Summit, ASQ, GridSecCon), and a Customer Advisory Board of 93 members from 59 companies across 13 industries. Pricing is quote-based with no publicly disclosed tiers, consistent with enterprise ACVs. The company is self-funded (no disclosed funding rounds), privately held, headquartered in Reno, Nevada, and operates with 51-100 employees and a remote workforce model that has been in place for over 20 years.
AssurX firmographics
Firmographics- Name
- AssurX
- Legal name
- AssurX, Inc.
- Website
- https://assurx.com
- Company type
- Private
- Founded year
- 2000
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- AssurX is a privately held, web-native enterprise quality management and regulatory compliance software vendor serving pharmaceutical, medical device, energy/utilities, and manufacturing buyers with pre-validated EQMS and NERC compliance modules delivered via cloud SaaS or on-premises.
- Ownership category
- akta.pro rank
AssurX industry classification
Industry- Product category
- Enterprise Quality Management Software
- NAICS
- Software Publishers (5132)
- SIC
- Services-Prepackaged Software (7372)
- akta.pro primary industry
- Cloud Compliance, Audit & Continuous Controls Monitoring (CCM/GRC) (HDABAHAI)
- akta.pro secondary industries
- GxP Audits & Supplier Qualification (GMP/GCP/GLP/GDP) (HLAGAKAE), ESG Data Platforms, Controls & Audit Readiness (Data quality, internal controls) (EUAHAJAN), Business Rules & Decision Management Platforms (BRMS/DMN) (HDAEAKAG), Enterprise Application Reporting, BI & Analytics Enablement (BPAEAGAK)
Keywords
Where AssurX is headquartered
LocationHeadquarters
- HQ city
- Reno
- HQ country
- United States
- HQ region
- North America
Offices3 records
Markets served
AssurX business model
Business model- GTM type
- B2B
- Offering type
- Software
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Infrastructure, Operations
Revenue model
- SaaS Subscription (Cloud): Cloud-based subscription model with multi-tenant architecture providing secure, reliable access to quality and compliance management systems. Pay-as-you-go pricing model with lower upfront costs compared to traditional software.
- On-Premises License: On-premises licensing option for organizations requiring local deployment. Same software functionality as cloud version.
- Professional Services: Implementation, integration, data migration, and training services to support deployment and adoption of the quality management system.
- Software Validation Services: Validation services to ensure compliance with regulatory requirements, including FDA 21 CFR Part 11, EU Annex 11, and computer system validation.
- Technical Support Services: Ongoing technical support services providing 24/7 assistance with reported satisfaction ratings.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Subscription | Monthly | Cloud QMS (SaaS) - subscription-based access with multi-tenant architecture |
| One time/ perpetual license | Annual | On-Premises License - perpetual or subscription licensing for local deployment |
Go-to-market motion1 record
Distribution channels5 records
Marketing channels9 records
AssurX product offering
Product offeringCore offering
AssurX develops and sells an enterprise Quality Management System (EQMS) platform that automates quality and regulatory compliance processes including CAPA, document management, training, supplier quality, complaint handling, change management, risk management, audit management, deviation, nonconformance, and validation for highly regulated industries. The company also offers the Energy Compliance Operating System (ECOS) for NERC and regional compliance, with both products available as cloud SaaS or on-premises deployments from a single code base.
Product overview
AssurX is an enterprise quality management and regulatory compliance software platform offering a unified system built on compliance. The portfolio consists of two core product lines: the Enterprise Quality Management Software (EQMS) platform and the Energy Compliance Operating System (ECOS) for NERC compliance. The EQMS platform includes 16 integrated modules covering CAPA Management, Training Management, Document Management, Supplier Quality Management, Customer Quality Management, Complaint Management, Change Management, Risk Management, Audit Management, Calibration Management, Deviation Management, Nonconformance Management, Quality Management Review, EHS Incident Management, Validation Management, and Design Control. For medical device manufacturers, specialized modules include eMDR (FDA electronic reporting) and EU MDR (EU Medical Device Regulation). ECOS provides energy sector-specific compliance automation. All solutions come pre-validated and are available as cloud-based SaaS or on-premise deployments. Professional services cover implementation, integration, data migration, validation, training, and technical support.
Differentiator
Problem solved
Functional benefit
Quantifiable outcome
- 65% reduction in server maintenance costs and 90% reduction in licensing costs for a pharmaceutical manufacturer
- +5 more outcomes
Companies that use AssurX
Customer profileNamed customers20 records
Segments7 records
Ideal customer profiles4 records
AssurX technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- Yes
- API docs
- API detail
Core technology
AI maturity
App detail
Integration8 records
Feature6 records
AssurX partnerships and signals
Strategic signalPartnerships
Nine partnerships are on record, tiered core and minor.
- SwitchcoreSwitch provides Tier 5 data center hosting for AssurX's cloud infrastructure. The partnership delivers 100% renewable energy backup systems, military-grade physical security, and 99.99% uptime. AssurX has received a Sustainability Certificate for using 100% renewable energy within the Switch ecosystem.
- 3Analyticsminor3Analytics provides AI-driven GxP-compliant platform for literature surveillance, signal management, IMDRF coding, and complaint processing. Partnership delivers AI/ML/NLP-powered solutions across drug safety, medical devices, cosmetovigilance, and vaccines.
- SikichminorSikich provides professional services including consulting and implementation support for AssurX solutions, addressing business challenges across multiple dimensions.
- BBA Engineering Ltd.minorBBA provides engineering and environmental consulting services with expertise in Energy and Natural Resources industry. 20 offices in Canada, USA, and Chile provide local support for AssurX implementations.
- FoxGuard SolutionsminorFoxGuard designs, manufactures, and integrates cybersecurity, computing, and regulatory compliance solutions for critical infrastructure markets, offering complete Patch and Update Management Program for IT and OT assets.
- TE3minorTE3 provides management system professional services including ISO 9001:2015, API Q1, Q2, and 20E certifications with over 35 years combined experience in quality assurance and control.
- BPMminorBPM provides in-depth cybersecurity advisory services to critical infrastructure clients in electric generation/distribution, water treatment, oil/gas, and telecommunications sectors.
- Launch ConsultingminorLaunch Consulting guides organizations through digital transformation, helping medical device, energy & utilities, and other regulated industries implement the right technology.
- ICF InternationalminorICF provides NERC compliance consulting services since 2006 with experts serving clients in all eight NERC regions. Over 40 years of market leadership in energy consulting.
Scale indicators7 records
Recent moves7 records
Expansion highlights6 records
AssurX competitors and assessment
Company assessmentDirect peers
- MasterControl: MasterControl is a direct competitor offering an enterprise QMS platform for life sciences, medical device, and other regulated industries, with overlapping modules in CAPA, document control, training, audit, and supplier quality — directly comparable to AssurX EQMS in target customers and use cases.
- Veeva Systems (Vault QMS): Veeva's Vault Quality Suite competes head-to-head with AssurX in pharma and biotech EQMS, providing document, training, change, deviation, audit, and complaint management for the same regulated customers AssurX serves (Sanofi-Genzyme, Cardinal Health, Lantheus).
- ETQ (part of Hexagon): ETQ Reliance is a long-standing enterprise QMS for manufacturing and life sciences, now backed by Hexagon, with overlapping CAPA, document, supplier quality, and audit functionality. It targets very similar regulated mid-market and enterprise customers as AssurX.
- Sparta Systems / TrackWise (Honeywell): TrackWise is an enterprise QMS widely used in pharma, medical device, and discrete manufacturing for CAPA, deviations, complaints, and audits. Now part of Honeywell, it directly overlaps AssurX's regulated-industry quality and compliance workflows.
- Ideagen (Quality & Compliance suite, including Qumas and Intellect): Ideagen's quality and compliance suite (formerly Qumas and Intellect) competes in regulated industries EQMS, with document management, CAPA, audit, and supplier quality modules in the same pharma and energy segments AssurX targets.
Emerging players
- ComplianceQuest: ComplianceQuest is a cloud-native EQMS built natively on Salesforce targeting the same regulated verticals as AssurX (life sciences, manufacturing, medical device), offering modern UX, AI features, and a single platform for quality, safety, and supplier management.
- Greenlight Guru: Greenlight Guru is a purpose-built QMS for medical device companies — a direct vertical overlap with AssurX's medical device customer segment (Philips Spectranetics, Abbott Medical), offering design controls, risk management, and FDA submission-ready workflows.
- Qualio: Qualio is a cloud-native QMS targeting life sciences startups and mid-market, with overlapping document, training, CAPA, and audit management capabilities and competing for the same pharma/medical device buyers as AssurX.
Broad incumbents
- Siemens Opcenter (Quality): Siemens Opcenter Quality (formerly Camstar) is a broad manufacturing QMS used by large discrete manufacturers — the same cohort as AssurX's Siemens and Honeywell factory customers — with deep MES/QMS integration across global operations.
- SAP S/4HANA Quality Management: SAP's quality management modules embedded within S/4HANA compete as the default QMS for large enterprises already standardized on SAP ERP — a buyer profile AssurX explicitly targets (Abbott Medical, other SAP-shop customers) and seeks to integrate with rather than displace.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
AssurX social profiles
Digital presenceAssurX compliance and trust
Trust signalCompliance6 records
AssurX financial estimates
Financial estimateRevenue estimate
Valuation estimate
AssurX leadership team
Management profileNumber of profiles
Profiles12 records
AssurX funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
AssurX M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about AssurX
What does AssurX do?
AssurX develops and sells an enterprise Quality Management System (EQMS) platform that automates quality and regulatory compliance processes including CAPA, document management, training, supplier quality, complaint handling, change management, risk management, audit management, deviation, nonconformance, and validation for highly regulated industries. The company also offers the Energy Compliance Operating System (ECOS) for NERC and regional compliance, with both products available as cloud SaaS or on-premises deployments from a single code base.
Is AssurX a public or private company?
AssurX is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was AssurX founded?
AssurX was founded in 2000. It employs 51 to 100 people.
Where is AssurX based?
AssurX is headquartered in Reno, United States, in the North America region.
How does AssurX make money?
Five revenue lines are on record. SaaS Subscription (Cloud) is the primary driver. The others are on-Premises License, professional Services, software Validation Services and technical Support Services.
Who are AssurX's main competitors?
Direct peers on record are MasterControl, Veeva Systems (Vault QMS), ETQ (part of Hexagon), Sparta Systems / TrackWise (Honeywell) and Ideagen (Quality & Compliance suite, including Qumas and Intellect). Emerging players are ComplianceQuest, Greenlight Guru and Qualio. Broad incumbents are Siemens Opcenter (Quality) and SAP S/4HANA Quality Management.
Does AssurX have an API?
Yes. AssurX offers an open API that supports integrations with CRM, ERP, LIMS, MES, and popular platforms including Salesforce, Tableau, SAP, Power BI, and ServiceNow. The API enables customers to integrate the AssurX QMS platform with other business systems for seamless data exchange.
What industry is AssurX in?
AssurX's product category is Enterprise Quality Management Software. Its primary akta.pro industry code is HDABAHAI, Cloud Compliance, Audit & Continuous Controls Monitoring (CCM/GRC), with a secondary code of HLAGAKAE, GxP Audits & Supplier Qualification (GMP/GCP/GLP/GDP). Its NAICS code is 5132 and its SIC code is 7372.