About AssurX

Purpose-Built Software for Regulated Industries

AssurX was built to help organizations operating in highly regulated environments manage quality, compliance, and operational risk with confidence.

Built on decades of experience supporting regulated organizations, the AssurX Platform provides configurable quality management and regulatory compliance software designed to support complex operational environments. Organizations use AssurX to maintain compliance standards, streamline critical workflows, manage risk, and support enterprise-wide governance—available through both cloud-based and on-premises subscription models.

Today, AssurX software is used by organizations across regulated industries, supporting operations on six continents and in more than 120 countries.

AssurX has global implementation worldwide in over 120 countries

COMPANIES AROUND THE WORLD TRUST ASSURX FOR THEIR QUALITY AND COMPLIANCE NEEDS

Duke Health uses AssurX Quality Management Software
AssurX QMS is used by Siemens
AssurX QMS is used by Sanofi-Genzyme
AssurX QMS is used by Honeywell
AssurX ECOS Compliance is used by Duke Energy
The Dollar Tree uses AssurX QMS
WL Gore uses AssurX Quality Management Software
Abbott Medical uses AssurX QMS
ITG Brands uses AssurX Quality Management Software

FAQ’s ABOUT ASSURX

No, we’ve been around for 25 years. In fact, we’ve been around longer than most of our competitors. Originally known as Intuitive Data Solutions, the founders changed the name to AssurX and incorporated in the state of California in March 2000.

We exist to provide the most configurable, adaptable and easy to use software platform that helps professionals effectively run their daily business. We do this by delivering complete solutions developed with a deep understanding of our clients’ needs and an honest dedication to our customers’ success. Our vision is to do for businesses what the mobile OS has done for people with a smartphone—keep the enterprise connected, informed, and coordinated. Our intention is to be the one software platform that empowers professionals to make informed decisions and easily orchestrate evolving business activities based on live intelligence from across the company.

We architected the AssurX EQMS product from the ground up in 1998 to be web-native. We launched the software in March 2000, and have built on that foundation ever since. We were the first web-based QMS system on the market. We were also the first to offer a single instance, multi-tenant, hosted (cloud) solution back in 2000.

We offer both SaaS and On-Prem licensing options. Our software is identical for both implementations, so we only have to maintain one source code. If you start on-prem, you can easily migrate to the cloud. And vice-versa.

Since we offer an open API, we support many integrations including CRM, ERP, LIMS, MES, including popular ones such as Salesforce, Tableau, SAP, Power BI, ServiceNow, etc. You can view more details here. 

Yes, AssurX thrives on customer-driven continuous improvement. Our Customer Advisory Board (CAB) is comprised of 93 individuals, represented by 59 companies in 13 industries. You can read more about it here. 

This quite common and often from companies who are unsatisfied with their current QMS system. We have done this with many QMS systems. Data mapping and migration is our expertise.

We begin with a migration assessment, map legacy data to AssurX structures, and validate through pilot workflows before full rollout.

Our servers are hosted in a private cloud at Switch, a Tier 5 datacenter. It’s much more reliable and secure than other commercially managed hosting providers. Read more about our SaaS offering. 

When we initially launched CATSWeb back in 2000, it was promoted as a Corrective Action Tracking System. Since those early days, our product has evolved exponentially. Today, our software is a full enterprise-level QMS and compliance system that incorporates all of the powerful features in CATSWeb and much more.

Yes, we are ISO27001:2022 certified and SOC 2 Type 2 compliant. In addition, we are also in compliance with HIPAA and GDPR. See our certifications.

Yes. AssurX supports adaptable workflows and configurable data structures so customers can meet 21 CFR Part 820, ISO 13485, ISO 9001, and similar standards.

Many. From medical device, pharma, biotech, food and cosmetics to electronics, aerospace, government, energy & utilities and general manufacturing. Basically anyone who is conscious of the quality of the products and services they provide.

What Sets Us Apart: Our Quality Policy

We’re committed to providing comprehensive and reliable quality and compliance management solutions through customer-driven continuous improvement.

QUALITY

AssurX is focused on delivering quality. We’ve learned from more than 20 years of targeted experience with hugely successful companies that the winners focus on customer satisfaction and product quality to drive profits and establish market leadership. Additionally, success begins with a relentless dedication to meeting our clients’ quality and compliance management needs and is backed with stable, reliable, innovative products. That’s the foundation and guiding force behind everything we do. Besides, if you’re in the business of quality and compliance, our job is to make your work easier and more profitable.

INNOVATION

We have a long history of innovation. From creating the first 100% web-based quality tracking application to offering the most comprehensive set of enterprise quality management and regulatory compliance solutions available today, we stay at the forefront of the industry. Above all, by keeping our business focused solely on quality and compliance, we’ve honed exceptional domain expertise, a motivated and talented workforce, and a clear vision for solving today’s global issues. We continue to use our focused expertise to create practical, flexible, and secure solutions that improve product and service quality, ease compliance procedures, enhance operations, and boost your bottom line.

TRUST

AssurX stands behind its products and services, and that’s why our customers stand behind us. We’ve earned continuous profitability and the highest customer satisfaction in the business. Among our many clients spanning dozens of industries globally, you’ll find customers who are not only successfully improving their operations with AssurX; you’ll find leading professionals ready to recommend us. At the same time, we are proudly the trusted quality and compliance management experts for some of the most prestigious businesses in the world.

“Why our employees love working at AssurX”

Stephanie Ojeda Director of Product Management,
Life Sciences & Manufacturing With a background of over 15 years in quality management, and having been a former AssurX customer myself, it's so fulfilling (and fun!) to be able to bring my perspective to the team. Shifting from a customer to actively contributing to the development and enhancement of our QMS solutions is so gratifying. Everyday, I get to use my experience to enhance existing solutions and work on creating new ones, making each day at AssurX exciting! Victoria Alestra Director of Software Quality Assurance "At AssurX, you have the freedom to grow. From the endless capabilities our software has to offer, to the boundless opportunities we have as employees, AssurX has fostered an environment that values teamwork and thrives on collaborating with customers. I am thankful to be part of the AssurX family, were I am valued, respected and surrounded by a fantastic team of understanding and remarkable people." Jim Yencer Director of Professional Services "At AssurX, I have helped countless customers improve the quality of their products and processes by helping them track quality and innovation at every level of a company with our software. So many times I have helped customers see the potential of AssurX and unleash their imaginations to track just about anything, and once they see what AssurX can do that's when they really begin to implement a Quality system that improves anything they want at the company." Maureen Charmack Project/Configuration Engineer "I was initially introduced to AssurX as a customer, where we developed solutions using the flexibility of the AssurX software. Since joining AssurX, I have had the opportunity to work with such a diverse group of customers and help them to grow their solutions to fit their needs. It’s exciting to be a member of the AssurX family that keeps evolving our solutions through teamwork and collaborating with our customers." Ryan Larson Account Manager
“Flexible? Check. Configurable? Yep. Creates efficiency? You bet.
AssurX offers a host of quality solutions all included in one tidy QMS package…creating tangible client value. I love guiding customers on how to make their jobs easier.” Rich Steurer Enterprise Sales Manager, Western Region “Working at AssurX gives me the opportunity to help prospects and clients from many different industries solve real business problems. I have a passion and enthusiasm for what I do and am very fortunate to have found an organization like AssurX, where the entire Team shares a similar outlook. Customer Success! One Team!” Tori Jim Yencer Maureen ryan rich AssurX Stephanie Ojeda Life Sciences Quality and Compliance Management Professional riding a horse on the beach

THE ONLY QUALITY & COMPLIANCE SOFTWARE YOU’LL EVER NEED.