Audit Management Software

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.

WEBINAR

Prepare for a Successful Audit Using an Automated QMS

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

ISO13485

EU MDR

GxP Standards

CASE STUDY

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

MRI System

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.

Generic background screen with the words "Quality Management and Regulatory Compliance Software" displayed in the foreground

“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 over...read 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-in-class solution.

You won’t be burdened with a scaled-down or inflexible quality management software solution. We’ve built the best solution to help you save time and maintain consistency.

Helpful equipment tool
Robotic arms
Helpful equipment tool
Wind turbines turning
Fan turning
Glass bottles stacked next to each other

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. This eliminates the need to budget for and install individual quality “modules.” Pre-configured workflows are available to you from day one with our quality management software.

AssurX is an exceptional platform that facilitates transitioning from a labor-intensive, paper-based process to a streamlined electronic system. By adopting AssurX, you can embrace the enhanced organization that comes with digitizing documents and files.

With AssurX, everything is easily searchable, allowing for quick retrieval and efficient information management. This level of organization drastically improves accessibility to records, reducing the time wasted.

First, implement the solutions you need now, then seamlessly connect more as you are ready. No other quality management system is easier to deploy, configure, and modify. Integrations with other software solutions make AssurX invaluable. Your data won’t be stuck in several silos. Instead, you’ll have one unified system for optimal efficiency.

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