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
• ISO13485
• EU MDR
• GxP Standards

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.

Automated Audit Process

AssurX automates and streamlines the audit process, from audit preparation and scheduling through execution, collection of observations, verification, and completion. It provides standardized audit and checklists templates. In addition, AssurX provides the capability to conduct remote audits and collaborate with suppliers.

Advanced Audit Tools

AssurX automatically logs audit findings and manages the response and resolution process. Quality events such as CAPA can be launched from the audit process when required for a seamless resolution of the issues. Attach unlimited files to any audit findings and records.

Cutting-edge Dashboards

Equip your team with robust dashboards that provide visibility into the system, data, status, and metrics in a secure environment. All stakeholders will see how every audit, finding, task, and trend is being handled.

Audit Library

Reduce audit preparation time by building an electronic library of reusable audit questions and processes that can be automatically applied to new audits.

Robust Analytics/Reports

It’s not enough to conduct audits. You also need to be able to generate reports regularly to make sure audit findings are addressed properly. With AssurX, you can generate print-ready reports with full audit details. It’s easy to query and access audit findings and reports.

Audit Trail/E-Signatures

AssurX QMS cloud-based change management software eliminates infrastructure and maintenance costs. If your business needs require an on-premise solution, AssurX offers that option as well. Either option reduces costs through centralization and automation. Furthermore, if you choose to migrate to a cloud solution later, the platforms are indistinguishable, and the transition is seamless.