Manage the Entire Audit Cycle

A Single Audit Solution to Engage the Entire Quality Value Chain

Audit Management Software for Regulated Companies

Audit is a major factor that demonstrates compliance with regulatory and customer requirements. However, the cost and complexities of most audit systems are keeping companies tied to outmoded paper-based or unconnected electronic systems.

If you want to establish a new audit system or improve your existing audit process, we can help you. AssurX audit management software is designed to automate and streamline all audit-related tasks and documentation. It facilitates internal audits and external audits (customer, regulatory agencies, other third parties) for compliance and continuous quality improvement.

Accelerate Compliance with Auditing Quality Management Rules

Regulatory bodies throughout the world, as well as ISO standards, require regular audits as an integral part of quality management. The FDA and its counterparts in the European Union, Canada, Australia, and Japan promote a global approach to audits through the Medical Device Single Audit Program. The initiative allows one audit for device firms to satisfy relevant requirements of participating regulatory bodies. AssurX is highly configurable, so you can easily add your own custom configurations based on your audit management requirements.

AssurX helps ensure safe and compliant products and services by addressing the requirements in:

21 CFR Part 11

21 CFR Part 820



GxP Standards

Diagnostic imaging agent manufacturer reduces operational and support costs by automating legacy and manual quality management processes into a single, powerful software platform.

Replacing legacy software quality systems with AssurX EQMS

AssurX Audit Management Software Aligns Business & Compliance Goals

AssurX can help  align your compliance efforts with your organization’s business goals. Use the audit process as a tool for examining specific processes, products or services for evaluation, decision making, and continuous quality improvement.

Here’s how AssurX audit management software can help you:

Watch a 13 Minute Video of the AssurX Audit Management Solution Now

See how to take advantage of AssurX’s powerful features to gain greater control of your audit management processes.

AssurX offers the entire QMS suite in a single, reliable platform. In the cloud or on-premise.

AssurX Quality Management and Regulatory Compliance Software

“Amazing system with endless configurable possibilities!”

The most helpful part of AssurX is the ability to configure it to our company needs. The biggest upside has been the ability to do away with the paper-based format we had…read the rest.

Jose C.
Quality System Software Administrator

“Very flexible and powerful”

With AssurX you can easily configure forms and workflows using the graphical tools provided.You can connect to multiple data sources quite easily. Their Professional Services team is full ofread the rest.

Sal D.
Principal Consultant

“I highly recommend AssurX as an EQMS system!”

AssurX is a Highly Configurable product and the Configuration specialist are very responsive. Using the Dev site as a template you can test out everything before migrating the rest.

Natalie P.
Quality System Software Administrator

AssurX: Quality & Compliance Systems for Every Enterprise

When you choose AssurX, you’re choosing decades of expertise in regulatory environments and innovation in quality management. Our unwavering focus on quality management means you’re getting a best-of-class solution, not a scaled-down or inflexible software solution.

One Platform. Every Solution.

Seamlessly integrate all quality management and regulatory compliance management processes with one software system. AssurX provides all core quality and compliance processes within the software system, eliminating the need to budget for and install individual quality “modules.” Pre-configured workflows are available to you from day one.

First, implement the solutions you need now, then seamlessly connect more as you are ready. No other system is easier to deploy, configure, and modify.

Audit Management

CAPA Management

Calibration Management

Change Management

Complaint Management

Customer Quality Management

Deviation Management

Document Management

EHS Incident Management

Nonconformance Management

Quality Management Review

Risk Management

Supplier Quality Management

Training Management

Validation Management Solution