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.
Key Takeaways…
Do you feel confident that you have all the key quality processes in place to support an audit, either announced or unplanned, with your current quality management solution? Properly organizing your quality data to help drive business decisions ensures you stay current on trending issues and allows you to be proactive vs. reactive.
During this webinar, AssurX will provide guidance on the steps needed to prepare for audits of all types, including internal audits, external customer audits, and regulatory compliance audits.
Highlights include:
- Best practices to leverage an automated platform for comprehensive documentation
- Demonstrate compliance to regulatory requirements
- Implement proactive measures to ensure continuous 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:
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:
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.
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.
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.
Reduce audit preparation time by building an electronic library of reusable audit questions and processes that can be automatically applied to new audits.
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.
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.
AssurX offers the entire QMS suite in a single, reliable platform. In the cloud or on-premise in addition to unparalleled professional services.
AssurX: Quality & Compliance Systems for Every Enterprise
The quality and compliance journey can be an obstacle course of changing regulations and standards in a dynamic global market. The AssurX enterprise quality management system (EQMS) and the AssurX Energy Compliance System (ECOS) help guide organizations through the complexities of any regulatory landscape.
Our dynamic, connected quality and compliance management solutions help guide your journey by automating processes to streamline event management, minimize risk, measure performance and facilitate change. The result is a proactive system that improves efficiency, compliance readiness, product quality, and customer satisfaction.
One Platform. Every Solution.
AssurX centralizes quality management and regulatory compliance processes within a single, configurable software platform. The system includes core quality and compliance workflows out of the box, eliminating the need for separate modules and reducing reliance on paper-based or disconnected systems.
Organizations can deploy the solutions they need today and add additional capabilities as requirements evolve. With pre-configured workflows, searchable data, and flexible integration options, AssurX supports efficient deployment, configuration, and long-term scalability across the enterprise.
