AssurX, Inc.

AssurX, Inc., founded March 1, 2000 and headquartered in Morgan Hill, California, sells enterprise quality management software (QMS) to regulated industries including pharmaceuticals, life sciences, medical devices, manufacturing, and energy & utilities.

The company's flagship product, the AssurX Enterprise QMS platform, provides CAPA (Corrective and Preventive Actions), deviation management, complaint handling, laboratory incident management, and compliance tracking. The platform holds ISO/IEC 27001:2022, SOC 2, and HIPAA certifications.

AssurX is privately held and bootstrapped, with no external venture capital funding over its 24+ year history. Employee count grew from 36 in December 2022 to 51 in September 2024. President & CEO Tamar June holds an 82% approval rating.

In the pharmaceutical sector, AssurX serves international pharmaceutical manufacturers including Servier, a global pharmaceutical and chemical company producing over 500 million boxes per year. The company maintains a dedicated pharmaceutical industry page and case studies covering GxP compliance, FDA regulations, and pharmaceutical quality management practices.

AssurX serves multiple regulated industries including pharmaceuticals, life sciences, medical devices, manufacturing, and energy & utilities; it is not pharma-only. The company maintains a dedicated pharmaceutical industry page covering regulatory compliance requirements specific to pharmaceutical manufacturing.

AssurX's pharmaceutical customer base includes Servier, an international pharmaceutical and chemical manufacturer producing over 500 million boxes per year. The Servier case study covers CAPA management, deviation tracking, complaint handling, laboratory incident management, and compliance management. The platform is designed to support GxP compliance and FDA regulatory requirements including 21 CFR Part 11.

Total customer count and the number or percentage of customers in the pharmaceutical sector are undisclosed. AssurX serves large pharmaceutical manufacturers, evidenced by the Servier implementation. FDA inspection pass rates and the total number of pharmaceutical customers are not published. The platform holds ISO/IEC 27001:2022, SOC 2, and HIPAA compliance certifications.

Revenue is undisclosed; AssurX is privately held with no public reporting requirements. The company has operated as a bootstrapped business since its March 2000 founding, with no external venture capital funding, per Crunchbase.

The quality management software market includes 432 active competitors, per Crunchbase's competitor analysis. Employee count increased from 36 in December 2022 to 51 in September 2024.

AssurX's flagship product is the AssurX Enterprise QMS platform, a quality management system for regulated industries. The platform provides CAPA (Corrective and Preventive Actions), deviation management, complaint handling, laboratory incident management, change control, and compliance management functionality.

The platform is built for configurability across pharmaceuticals, medical devices, and other regulated industries. User feedback highlights high configurability and CAPA tracking. The deployment model (cloud-native SaaS vs on-premise) is undisclosed. Integration capabilities with other enterprise systems are mentioned in pharmaceutical implementations, but specific technology partnerships are not disclosed. The platform holds ISO/IEC 27001:2022, SOC 2, and HIPAA certifications.

Technology partnerships with major cloud providers (AWS, Azure, Google Cloud) or enterprise software vendors (SAP, Oracle, Salesforce) are undisclosed. Implementation and consulting partner networks are not detailed on public-facing pages.

ISPE (International Society for Pharmaceutical Engineering) membership or participation in pharmaceutical industry groups is not mentioned in available sources. The company holds ISO/IEC 27001:2022, SOC 2, and HIPAA compliance certifications.

AssurX provides customer support and professional services for implementation and ongoing system use. Support hours (24/7 availability), regional support coverage, and supported languages are undisclosed. Validation service offerings for pharmaceutical customers are undisclosed. A user community, annual conference, or certification program is not mentioned in available sources.

User feedback describes "good support" alongside a "steep learning curve" and "complex initial configuration" for the AssurX platform.

AssurX holds ISO/IEC 27001:2022 (information security management), SOC 2 (service organization controls), and HIPAA (health information privacy) certifications. ISO 9001 certification status is undisclosed.

AssurX is listed on G2, Capterra, and Gartner Peer Insights. User reviews praise the platform's configurability, CAPA tracking, and customer support. User feedback also describes a steep learning curve and complex initial configuration. No Gartner Magic Quadrant, Forrester Wave, or other analyst recognition is documented.

President & CEO Tamar June holds an 82% approval rating. The company has operated since March 2000, a 24+ year history, in a market with 432 active competitors. No whitepapers, blogs, webinars, or speaking engagements are published.

AssurX maintains a web presence with a dedicated pharmaceutical industry page and customer case studies. The company has a LinkedIn presence at linkedin.com/company/assurx with 1,401 followers.

AssurX is listed on G2, Capterra, and Gartner Peer Insights. Customer case studies include the Servier implementation. Whether the company maintains an active resource center with whitepapers, webinars, or blog content, or offers product demos and free trials, is undisclosed.